A Safety and Efficacy Study of Intetumumab, Alone and in... | NCT00246012 | Trialant
NCT00246012
Sponsor
Centocor, Inc.
Status
Completed
Last Update Posted
Aug 19, 2013Estimated
Enrollment
144Actual
Phase
Phase 1Phase 2
Conditions
Melanoma
Interventions
Intetumumab
Dacarbazine
Placebo
Countries
United States
Germany
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00246012
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR006004
Secondary IDs
ID
Type
Description
Link
C1034T02
Other Identifier
Centocor, Inc
2004-002130-18
EudraCT Number
Brief Title
A Safety and Efficacy Study of Intetumumab, Alone and in Combination With Dacarbazine, in Participants With Stage 4 Melanoma
Official Title
A Phase 1/2, Multi-Center, Blinded, Randomized, Controlled Study of the Safety and Efficacy of the Human Monoclonal Antibody to Human α ν Integrins (CNTO 95), Alone and in Combination With Dacarbazine, in Subjects With Stage IV Melanoma
Acronym
Not provided
Organization
Centocor, Inc.INDUSTRY
Status Module
Record Verification Date
Jul 2013
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2005
Primary Completion Date
Jun 2008Actual
Completion Date
Feb 2009Actual
First Submitted Date
Oct 28, 2005
First Submission Date that Met QC Criteria
Oct 28, 2005
First Posted Date
Oct 31, 2005Estimated
Results Waived
Not provided
Results First Submitted Date
May 1, 2013
Results First Submitted that Met QC Criteria
Jul 17, 2013
Results First Posted Date
Aug 19, 2013Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 17, 2013
Last Update Posted Date
Aug 19, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Centocor, Inc.INDUSTRY
Collaborators
Name
Class
Janssen-Cilag Farmaceutica, S.R.L.
UNKNOWN
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the intetumumab, alone and in combination with dacarbazine, in patients with stage 4 melanoma.
Detailed Description
This is a Phase 1/2, multi-center, randomized (the study medication is assigned by chance) study. This study will be conducted in 2 Phases (Phase 1 and Phase 2). Phase 1 of this study will be non-randomized, open-label (all people know the identity of the intervention) and dose-escalation phase. It includes screening period and treatment period, which consists of 2 parts (Part 1 and Part 2). In Part 1, participants will receive 1 of 3 single dose levels of intetumumab [3 milligram per kilogram (mg/kg), 5 mg/kg or 10 mg/kg]. Part 2 will include 2 dose cohorts: dacarbazine plus intetumumab (5 mg/kg) or dacarbazine plus intetumumab (10 mg/kg). Phase 2 of this study will be randomized, blinded (neither physician nor participant knows the intervention which the participant will receive) and controlled (an inactive substance and other medication is compared with a study medication to test whether the medication has a real effect in this clinical study). This phase of the study will include screening period, treatment period (8 cycles of treatment with every cycle once in 3 weeks) and follow-up period (24 weeks). During the treatment period, participants will be randomly assigned to 1 of 4 treatment groups, Group 1: dacarbazine plus placebo, Group 2: intetumumab (5 mg/kg), Group 3: intetumumab (10 mg/kg) and Group 4: dacarbazine plus intetumumab. Randomization will be further based on the site of metastases and Eastern Cooperative Oncology Group performance status at Baseline. Single-medication intetumumab treatment groups will be open-label, while the dacarbazine plus intetumumab or placebo groups will be blinded. The total duration of the Phase 2 of this study will be up to 52 weeks or up to 76 weeks in case of extended dosing (extended administrations [up to 8 additional cycles] of the same assigned treatment will be allowed for participants that are responding to therapy with stable disease or better). Participants will be assessed for incidence of dose limiting toxicities, pharmacokinetics and tumor responses. Participants' safety will be monitored throughout the study.
Conditions Module
Conditions
Melanoma
Keywords
Melanoma
Neoplasm
CNTO 95
Dacarbazine
Intetumumab
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
144Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Intetumumab 3 mg/kg [Phase 1 (Part 1)]
Experimental
Intetumumab will be administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation is not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab will be discontinued in Part 1 and participants will be treated at the highest, documented safe dose level at which receptor saturation is observed.
Drug: Intetumumab
Intetumumab 5 mg/kg [Phase 1 (Part 1)]
Experimental
Intetumumab will be administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation is not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab will be discontinued in Part 1 and participants will be treated at the highest, documented safe dose level at which receptor saturation is observed.
Drug: Intetumumab
Intetumumab 10 mg/kg [Phase 1 (Part 1)]
Experimental
Intetumumab will be administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
Intetumumab will be administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). In Phase 2, intetumumab (5 mg/kg or 10 mg/kg) will be administered for 8 cycles until no evidence of disease progression or unacceptable toxicity. If a participant responds to therapy with stable disease (SD) or better, the participant will be eligible to receive up to 8 cycles of extended administrations.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs) - Phase 1
The DLT is defined as any Grade 3 or higher adverse event identified by the safety data monitoring committee as attributable to intetumumab except for hypersensitivity reactions, which are not considered DLTs unless there are 2 or more occurrences of greater than or equal to Grade 3 hypersensitivity reaction within a group.
Up to 21 days post-first infusion from the last treated participant in Phase 1
Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 1 (Part 1)
The maximum observed analyte concentration in serum was reported.
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
Area Under the Serum Concentration Versus Time Curve (AUC) of Intetumumab - Phase 1 (Part 1)
The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
Half-life of Intetumumab - Phase 1 (Part 1)
Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
Total Clearance (CL) of Intetumumab After Intravenous Administration - Phase 1 (Part 1)
The CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Achieved a Best Overall Tumor Response as Complete Response (CR) or Partial Response (PR) - Phase 2
The CR: complete disappearance of all measurable and non-measurable target lesions and PR: 50 percent (%) or more decrease in sum of the longest diameters of target lesion(s), with at least stable disease (SD) in all other evaluable disease in the absence of treatment failure. The best response achieved among all the evaluated time points was reported.
Other Outcomes
Measure
Description
Time Frame
Area Under the Concentration Versus Time Curve Between Zero to Infinite Time (AUCinf) of Intetumumab - Phase 1 (Part 1)
The AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed melanoma including ocular and mucosal
Radiographically measurable disease or measurable skin lesions
Prior chemotherapy for metastatic melanoma will be allowed for Phase 1, while previously untreated for melanoma by chemotherapy will be allowed for Phase 2
Agrees to protocol-defined use of effective contraception
Exclusion Criteria:
History of receiving murine or human/murine recombination products of human αν integrins
Known human immunodeficiency virus (HIV) positivity and clinically important active infection
Presence of bone metastases or malignant effusions (non-measurable lesions) and central nervous system metastases
Prior radiation to target lesions
Concurrent immunotherapy, biotherapy, radiotherapy, chemotherapy, or investigational therapy and therapeutic use of anticoagulation
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Centocor, Inc. Clinical Trial
Centocor, Inc.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Scottsdale
Arizona
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Intetumumab 3 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Austria
Belgium
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Intetumumab will be administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants respond to therapy with stable disease (SD) or better, they will be considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine will be administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Intetumumab will be administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants respond to therapy with SD or better, they will be considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine will be administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Drug: Intetumumab
Drug: Dacarbazine
Dacarbazine + placebo [Phase 2]
Experimental
Placebo will be administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine will be administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants are unable to tolerate dacarbazine even after 2 dose reductions, they will be given the option to continue with 10 mg/kg intetumumab alone.
Drug: Dacarbazine
Drug: Placebo
Intetumumab 5 mg/kg [Phase 2]
Experimental
Intetumumab will be administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants respond to therapy with SD or better, they are considered eligible to receive up to 8 cycles of extended administrations.
Drug: Intetumumab
Intetumumab 10 mg/kg [Phase 2]
Experimental
Intetumumab will be administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants respond to therapy with SD or better, they are considered eligible to receive up to 8 cycles of extended administrations.
Drug: Intetumumab
Dacarbazine + intetumumab 10 mg/kg [Phase 2]
Experimental
Intetumumab will be administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants respond to therapy with SD or better, they are considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine will be administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Commercially available dacarbazine will be administered intravenously over a 60-minute period (+30 minutes/-30 minutes) and prior to the intetumumab/placebo infusion. In case participants are unable to tolerate dacarbazine even after 2 dose reductions, they will be given the option to continue on intetumumab alone.
Placebo will be administered intravenously over a period of 2 hours (+15 minutes/-15 minutes).
Dacarbazine + placebo [Phase 2]
Volume of Distribution (Vz) of Intetumumab - Phase 1 (Part 1)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
Accumulation Ratio (R) of Intetumumab - Phase 1 (Part 1)
The R is obtained by dividing AUC at two different time points.
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
Progression-Free Survival (PFS) - Phase 2
The PFS was defined as the time from the date of randomization to the date of initial documented progressive disease (PD), or the date of initial documented symptomatic deterioration, or the date of death, whichever occurred first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as a reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions.
From the date of randomization to date of initial documented progressive disease or death, whichever occured first, as assessed upto 6 months after last dose of study medication
Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable)
Percentage of Participants Who Achieved CR - Phase 2
The CR: complete disappearance of all measurable and non-measurable target lesions. The participants who achieved CR as the best response were reported.
Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable)
Percentage of Participants Who Achieved Stable Disease (SD) - Phase 2
The SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive disease (PD), taking as a reference the smallest sum longest diameter since the treatment started. The participants who achieved SD as the best response were reported.
Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable)
Overall Survival (OS) - Phase 2
The OS is defined as the time from the date of randomization to the date of death due to any cause and was to be censored at the date that the subject is last known to be alive.
Every 3 months until death, until lost to follow-up, until withdrawal of consent, or until the Sponsor ends the study, as assessed up to 6 months post-last dose of study medication
Duration of Response - Phase 2
Time duration required to achieve a CR or PR.
From the time of initial documented response (CR or PR) to the first documented sign of progression, assessed up to 6 months post-last dose of study medication
Time to Worsening in Eastern Cooperative Oncology Group (ECOG) Performance Status - Phase 2
Eastern Cooperative Oncology (ECOG) performance status: Participants will be graded from 0 (Fully active, able to carry on all pre-disease activities without restriction) to 4 (Completely disabled, cannot carry on any self-care, totally confined to bed or chair). Worsening in ECOG score was defined as ≥ 1 point increase in ECOG score from baseline.
Baseline (within 7 days of first infusion of study medication), Day 1 of all 8 cycles, 3 weeks or 1 week post-last dose, 3 months and 6 months post-last dose of study medication
Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 2
The maximum observed analyte concentration in serum was reported.
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
Change From Baseline in Functional Assessment of Cancer Therapy-Melanoma Subscale (FACT-MS) Score - Phase 2
The FACT-MS subscale is used to evaluate health related quality of life. It consists of 16 items: 12 items related to physical well-being, 3 to emotional well-being and 1 to social well-being. Scores for all items will range from 0 to 4. Total score ranges from 0-64; higher score indicates a more positive quality of life.
Day 1 (pre-dose) of Cycles 1, 2, 3; and final visit (3 weeks post-last dose of study medication)
Change From Baseline in Brief Pain Inventory (BPI) Score - Phase 2
The BPI questionnaire is used to evaluate heath related quality of life. BPI allows participants to rate the severity of their pain on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).
Day 1 (pre-dose) of Cycles 1, 2, 3; and final visit (3 weeks post-last dose of study medication)
Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 1 (Part 2)
The maximum observed analyte concentration in serum was reported.
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
Area Under the Serum Concentration Versus Time Curve (AUC) of Intetumumab - Phase 1 (Part 2)
The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
Half-life of Intetumumab - Phase 1 (Part 2)
Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
Total Clearance (CL) of Intetumumab After Intravenous Administration - Phase 1 (Part 2)
The CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
Volume of Distribution (Vz) of Intetumumab - Phase 1 (Part 2)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
Accumulation Ratio (R) of Intetumumab - Phase 1 (Part 2)
The R is obtained by dividing AUC at two different time points.
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
Percentage of Participants Who Achieved a Best Overall Response as CR, PR, or SD - Phase 2
The CR: complete disappearance of all measurable and non-measurable target lesions and PR: 50% or more decrease in sum of the longest diameters of target lesion(s), with at least stable disease (SD) in all other evaluable disease in the absence of treatment failure.
Within 28 days of first infusion of study medication, within 1 week of the end of Cycles 2, 4, 6, 8; 3 months and 6 months post-last dose of study medication
La Jolla
California
United States
Santa Monica
California
United States
Walnut Creek
California
United States
Aurora
Colorado
United States
Washington D.C.
District of Columbia
United States
Miami
Florida
United States
Atlanta
Georgia
United States
Park Ridge
Illinois
United States
Beech Grove
Indiana
United States
Omaha
Nebraska
United States
Buffalo
New York
United States
New York
New York
United States
Philadelphia
Pennsylvania
United States
Nashville
Tennessee
United States
Dallas
Texas
United States
Seattle
Washington
United States
Berlin
Germany
Bonn
Germany
Buxtehude
Germany
Düsseldorf
Germany
Essen
Germany
Hanover
Germany
Jena
Germany
Kiel
Germany
Mannheim
Germany
Münster
Germany
Cambridge
United Kingdom
London
United Kingdom
Manchester
United Kingdom
Sheffield
United Kingdom
Southampton
United Kingdom
FG001
Intetumumab 5 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
FG002
Intetumumab 10 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
FG005
Dacarbazine + Placebo [Phase 2]
Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
FG006
Intetumumab 5 mg/kg [Phase 2]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
FG007
Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
FG008
Dacarbazine + Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0043 subjects
FG00532 subjects
FG00632 subjects
FG00733 subjects
FG00832 subjects
Treated
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0043 subjects
FG00531 subjects
FG00631 subjects
FG00733 subjects
FG00832 subjects
COMPLETED
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0054 subjects
FG0061 subjects
FG0075 subjects
FG0084 subjects
NOT COMPLETED
FG0003 subjects
FG0011 subjects
FG0022 subjects
FG0033 subjects
FG0043 subjects
FG00528 subjects
FG00631 subjects
FG00728 subjects
FG00828 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Disease progression
FG0003 subjects
FG0011 subjects
FG0022 subjects
FG0033 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Randomly assigned but not treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Intetumumab 3 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
BG001
Intetumumab 5 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
BG002
Intetumumab 10 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
BG005
Dacarbazine + Placebo [Phase 2]
Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
BG006
Intetumumab 5 mg/kg [Phase 2]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
BG007
Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
BG008
Dacarbazine + Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0023
BG0033
BG0043
BG00531
BG00631
BG00733
BG00832
BG009142
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00062.0± 10.82
BG00146.7± 6.66
BG00261.7± 11.59
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0011
BG002
Region of Enrollment
Number
Participants
Title
Denominators
Categories
Germany
Title
Measurements
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose Limiting Toxicities (DLTs) - Phase 1
The DLT is defined as any Grade 3 or higher adverse event identified by the safety data monitoring committee as attributable to intetumumab except for hypersensitivity reactions, which are not considered DLTs unless there are 2 or more occurrences of greater than or equal to Grade 3 hypersensitivity reaction within a group.
Safety population included all the participants who received at least 1 (partial or complete) dose of intetumumab/placebo or dacarbazine.
Posted
Number
Participants
Up to 21 days post-first infusion from the last treated participant in Phase 1
ID
Title
Description
OG000
Intetumumab 3 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
OG001
Intetumumab 5 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
OG002
Intetumumab 10 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 1 (Part 1)
The maximum observed analyte concentration in serum was reported.
The Pharmacokinetics (PK)-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab.
Posted
Mean
Standard Deviation
Microgram per milliliter (mcg/mL)
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
ID
Title
Description
OG000
Intetumumab 3 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
OG001
Intetumumab 5 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
Primary
Area Under the Serum Concentration Versus Time Curve (AUC) of Intetumumab - Phase 1 (Part 1)
The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Mean
Standard Deviation
mcg*day/mL
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
ID
Title
Description
OG000
Intetumumab 3 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
OG001
Intetumumab 5 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
Primary
Half-life of Intetumumab - Phase 1 (Part 1)
Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.
The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Mean
Standard Deviation
Days
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
ID
Title
Description
OG000
Intetumumab 3 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
OG001
Intetumumab 5 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
Primary
Total Clearance (CL) of Intetumumab After Intravenous Administration - Phase 1 (Part 1)
The CL is a quantitative measure of the rate at which a drug substance is removed from the body.
The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Mean
Standard Deviation
mL/day/kg
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
ID
Title
Description
OG000
Intetumumab 3 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
OG001
Intetumumab 5 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
Primary
Volume of Distribution (Vz) of Intetumumab - Phase 1 (Part 1)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Mean
Standard Deviation
mL/kg
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
ID
Title
Description
OG000
Intetumumab 3 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
OG001
Intetumumab 5 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
Primary
Accumulation Ratio (R) of Intetumumab - Phase 1 (Part 1)
The R is obtained by dividing AUC at two different time points.
The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. Serum concentration data was insufficient to robustly estimate the accumulation ratio.
Posted
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
ID
Title
Description
OG000
Intetumumab 3 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
OG001
Intetumumab 5 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
Primary
Progression-Free Survival (PFS) - Phase 2
The PFS was defined as the time from the date of randomization to the date of initial documented progressive disease (PD), or the date of initial documented symptomatic deterioration, or the date of death, whichever occurred first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as a reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions.
The Intent-to-treat (ITT) population included all the participants who were randomly assigned to treatment.
Posted
Median
95% Confidence Interval
Days
From the date of randomization to date of initial documented progressive disease or death, whichever occured first, as assessed upto 6 months after last dose of study medication
ID
Title
Description
OG000
Dacarbazine + Placebo [Phase 2]
Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
OG001
Intetumumab 5 mg/kg [Phase 2]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
Secondary
Percentage of Participants Who Achieved a Best Overall Tumor Response as Complete Response (CR) or Partial Response (PR) - Phase 2
The CR: complete disappearance of all measurable and non-measurable target lesions and PR: 50 percent (%) or more decrease in sum of the longest diameters of target lesion(s), with at least stable disease (SD) in all other evaluable disease in the absence of treatment failure. The best response achieved among all the evaluated time points was reported.
The response-evaluable population included all the participants who were evaluable for response.
Posted
Number
Percentage of Participants
Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable)
ID
Title
Description
OG000
Dacarbazine + Placebo [Phase 2]
Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
OG001
Intetumumab 5 mg/kg [Phase 2]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
Secondary
Percentage of Participants Who Achieved CR - Phase 2
The CR: complete disappearance of all measurable and non-measurable target lesions. The participants who achieved CR as the best response were reported.
The response-evaluable population included all the participants who were evaluable for response.
Posted
Number
Percentage of Participants
Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable)
ID
Title
Description
OG000
Dacarbazine + Placebo [Phase 2]
Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
OG001
Intetumumab 5 mg/kg [Phase 2]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
Secondary
Percentage of Participants Who Achieved Stable Disease (SD) - Phase 2
The SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive disease (PD), taking as a reference the smallest sum longest diameter since the treatment started. The participants who achieved SD as the best response were reported.
The response-evaluable population included all the participants who were evaluable for response.
Posted
Number
Percentage of Participants
Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable)
ID
Title
Description
OG000
Dacarbazine + Placebo [Phase 2]
Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
OG001
Intetumumab 5 mg/kg [Phase 2]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
Secondary
Overall Survival (OS) - Phase 2
The OS is defined as the time from the date of randomization to the date of death due to any cause and was to be censored at the date that the subject is last known to be alive.
The ITT population included all the participants who were randomly assigned to treatment.
Posted
Median
95% Confidence Interval
Days
Every 3 months until death, until lost to follow-up, until withdrawal of consent, or until the Sponsor ends the study, as assessed up to 6 months post-last dose of study medication
ID
Title
Description
OG000
Dacarbazine + Placebo [Phase 2]
Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
OG001
Intetumumab 5 mg/kg [Phase 2]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
Secondary
Duration of Response - Phase 2
Time duration required to achieve a CR or PR.
The response-evaluable population included all the participants who were evaluable for response. The results were reported as individual participant's listings, but not statistically summarized.
Posted
From the time of initial documented response (CR or PR) to the first documented sign of progression, assessed up to 6 months post-last dose of study medication
ID
Title
Description
OG000
Dacarbazine + Placebo [Phase 2]
Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
OG001
Intetumumab 5 mg/kg [Phase 2]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
OG002
Intetumumab 10 mg/kg [Phase 2]
Secondary
Time to Worsening in Eastern Cooperative Oncology Group (ECOG) Performance Status - Phase 2
Eastern Cooperative Oncology (ECOG) performance status: Participants will be graded from 0 (Fully active, able to carry on all pre-disease activities without restriction) to 4 (Completely disabled, cannot carry on any self-care, totally confined to bed or chair). Worsening in ECOG score was defined as ≥ 1 point increase in ECOG score from baseline.
The ITT population included all the participants who were randomly assigned to treatment.
Posted
Median
95% Confidence Interval
Days
Baseline (within 7 days of first infusion of study medication), Day 1 of all 8 cycles, 3 weeks or 1 week post-last dose, 3 months and 6 months post-last dose of study medication
ID
Title
Description
OG000
Dacarbazine + Placebo [Phase 2]
Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
OG001
Intetumumab 5 mg/kg [Phase 2]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
Secondary
Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 2
The maximum observed analyte concentration in serum was reported.
The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab.
Posted
Mean
Standard Deviation
mcg/mL
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
ID
Title
Description
OG000
Dacarbazine + Placebo [Phase 2]
Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
OG001
Intetumumab 5 mg/kg [Phase 2]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
OG002
Secondary
Change From Baseline in Functional Assessment of Cancer Therapy-Melanoma Subscale (FACT-MS) Score - Phase 2
The FACT-MS subscale is used to evaluate health related quality of life. It consists of 16 items: 12 items related to physical well-being, 3 to emotional well-being and 1 to social well-being. Scores for all items will range from 0 to 4. Total score ranges from 0-64; higher score indicates a more positive quality of life.
The ITT population included all the participants who were randomly assigned to treatment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.
Posted
Mean
Standard Deviation
Units on a scale
Day 1 (pre-dose) of Cycles 1, 2, 3; and final visit (3 weeks post-last dose of study medication)
ID
Title
Description
OG000
Dacarbazine + Placebo [Phase 2]
Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
OG001
Intetumumab 5 mg/kg [Phase 2]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
Secondary
Change From Baseline in Brief Pain Inventory (BPI) Score - Phase 2
The BPI questionnaire is used to evaluate heath related quality of life. BPI allows participants to rate the severity of their pain on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).
The ITT population included all the participants who were randomly assigned to treatment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.
Posted
Mean
Standard Deviation
Units on a scale
Day 1 (pre-dose) of Cycles 1, 2, 3; and final visit (3 weeks post-last dose of study medication)
ID
Title
Description
OG000
Dacarbazine + Placebo [Phase 2]
Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
OG001
Intetumumab 5 mg/kg [Phase 2]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
Secondary
Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 1 (Part 2)
The maximum observed analyte concentration in serum was reported.
The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Mean
Standard Deviation
Microgram per milliliter (mcg/mL)
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Secondary
Area Under the Serum Concentration Versus Time Curve (AUC) of Intetumumab - Phase 1 (Part 2)
The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Mean
Standard Deviation
mcg*day/mL
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Secondary
Half-life of Intetumumab - Phase 1 (Part 2)
Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.
The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Mean
Standard Deviation
Days
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Secondary
Total Clearance (CL) of Intetumumab After Intravenous Administration - Phase 1 (Part 2)
The CL is a quantitative measure of the rate at which a drug substance is removed from the body.
The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Mean
Standard Deviation
mL/day/kg
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Secondary
Volume of Distribution (Vz) of Intetumumab - Phase 1 (Part 2)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Mean
Standard Deviation
mL/kg
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Secondary
Accumulation Ratio (R) of Intetumumab - Phase 1 (Part 2)
The R is obtained by dividing AUC at two different time points.
The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. Serum concentration data was insufficient to robustly estimate the accumulation ratio.
Posted
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Other Pre-specified
Area Under the Concentration Versus Time Curve Between Zero to Infinite Time (AUCinf) of Intetumumab - Phase 1 (Part 1)
The AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Posted
Mean
Standard Deviation
mcg*day/mL
Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose
ID
Title
Description
OG000
Intetumumab 3 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
OG001
Intetumumab 5 mg/kg [Phase 1 (Part 1)]
Other Pre-specified
Percentage of Participants Who Achieved a Best Overall Response as CR, PR, or SD - Phase 2
The CR: complete disappearance of all measurable and non-measurable target lesions and PR: 50% or more decrease in sum of the longest diameters of target lesion(s), with at least stable disease (SD) in all other evaluable disease in the absence of treatment failure.
The response-evaluable population included all the participants who were evaluable for response.
Posted
Number
Percentage of Participants
Within 28 days of first infusion of study medication, within 1 week of the end of Cycles 2, 4, 6, 8; 3 months and 6 months post-last dose of study medication
ID
Title
Description
OG000
Dacarbazine + Placebo [Phase 2]
Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
OG001
Intetumumab 5 mg/kg [Phase 2]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
Time Frame
Day 1 up to Follow-up period (30 days post-last dose).
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Intetumumab 3 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
2
3
3
3
EG001
Intetumumab 5 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
1
3
3
3
EG002
Intetumumab 10 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
2
3
3
3
EG005
Dacarbazine + Placebo [Phase 2]
Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
9
31
30
31
EG006
Intetumumab 5 mg/kg [Phase 2]
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
4
31
30
31
EG007
Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
6
33
32
33
EG008
Dacarbazine + Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
7
32
30
32
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile Neutropenia
Blood and lymphatic system disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG004
Neutropenia
Blood and lymphatic system disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cyanosis
Cardiac disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Eye Haemorrhage
Eye disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Disease Progression
General disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
General Physical Health Deterioration
General disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Anaphylactic Reaction
Immune system disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Appendicitis
Infections and infestations
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Gastroenteritis Norovirus
Infections and infestations
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Infection
Infections and infestations
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Wound Infection
Infections and infestations
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Malignant Pleural Effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Metastases to Central Nervous System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neoplasm Progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Skin Neoplasm Bleeding
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tumour Haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cerebrovascular Accident
Nervous system disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypotonia
Nervous system disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Reversible Posterior Leukoencephalopathy Syndrome
Nervous system disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Spinal Cord Compression
Nervous system disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pneumonia Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pallor
Vascular disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA V10.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected3 at risk
EG0056 affected31 at risk
EG0061 affected31 at risk
EG0070 affected33 at risk
EG0087 affected32 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Palpitations
Cardiac disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperparathyroidism
Endocrine disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Eye Irritation
Eye disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Eye Pain
Eye disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lacrimation Increased
Eye disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ocular Discomfort
Eye disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Ocular Hyperaemia
Eye disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Uveitis
Eye disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Visual Acuity Reduced
Eye disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Vitreous Floaters
Eye disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Abdominal Tenderness
Gastrointestinal disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA V10.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0012 affected3 at risk
EG0020 affected3 at risk
EG003
Rectal Haemorrhage
Gastrointestinal disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0012 affected3 at risk
EG0020 affected3 at risk
EG003
Chest Pain
General disorders
MedDRA V10.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Chills
General disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0013 affected3 at risk
EG0020 affected3 at risk
EG003
Fatigue
General disorders
MedDRA V10.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0012 affected3 at risk
EG0020 affected3 at risk
EG003
Influenza Like Illness
General disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Infusion Site Extravasation
General disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Infusion Site Pain
General disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oedema Peripheral
General disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pain
General disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA V10.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0013 affected3 at risk
EG0020 affected3 at risk
EG003
Abscess
Infections and infestations
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Influenza
Infections and infestations
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Oral Herpes
Infections and infestations
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Rhinitis
Infections and infestations
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Sinusitis
Infections and infestations
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Procedural Pain
Injury, poisoning and procedural complications
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Wound Secretion
Injury, poisoning and procedural complications
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood Alkaline Phosphatase Increased
Investigations
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Blood Lactate Dehydrogenase Increased
Investigations
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Heart Rate Increased
Investigations
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Weight Decreased
Investigations
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Bone Pain
Musculoskeletal and connective tissue disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0012 affected3 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Musculoskeletal Stiffness
Musculoskeletal and connective tissue disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Tumour Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Disturbance in Attention
Nervous system disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA V10.0
Non-systematic Assessment
EG0003 affected3 at risk
EG0013 affected3 at risk
EG0022 affected3 at risk
EG003
Neuropathy Peripheral
Nervous system disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Libido Decreased
Psychiatric disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Menstruation Irregular
Reproductive system and breast disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Sexual Dysfunction
Reproductive system and breast disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA V10.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA V10.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pharyngolaryngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pulmonary Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Night Sweats
Skin and subcutaneous tissue disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA V10.0
Non-systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Vitiligo
Skin and subcutaneous tissue disorders
MedDRA V10.0
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Hot Flush
Vascular disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA V10.0
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
LTE60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Director
Centocor, Inc.
908-927-2116
ID
Term
D008545
Melanoma
D009369
Neoplasms
Ancestor Terms
ID
Term
D018358
Neuroendocrine Tumors
D017599
Neuroectodermal Tumors
D009373
Neoplasms, Germ Cell and Embryonal
D009370
Neoplasms by Histologic Type
D009380
Neoplasms, Nerve Tissue
D018326
Nevi and Melanomas
D012878
Skin Neoplasms
D009371
Neoplasms by Site
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C486839
intetumumab
D003606
Dacarbazine
Ancestor Terms
ID
Term
D014226
Triazenes
D009930
Organic Chemicals
D007093
Imidazoles
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
3 subjects
FG00525 subjects
FG00630 subjects
FG00727 subjects
FG00826 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
0 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
52.7
± 15.01
BG00466.0± 18.73
BG00563.5± 14.17
BG00667.3± 11.44
BG00761.5± 12.39
BG00857.2± 11.45
BG00961.8± 12.87
1
BG0031
BG0041
BG00513
BG0068
BG0077
BG00814
BG00947
Male
BG0002
BG0012
BG0022
BG0032
BG0042
BG00518
BG00623
BG00726
BG00818
BG00995
0
BG0030
BG0040
BG0059
BG00612
BG00710
BG00813
BG00944
United Kingdom
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0056
BG0069
BG0074
BG0085
BG00924
United States
Title
Measurements
BG0003
BG0013
BG0023
BG0033
BG0043
BG00516
BG00610
BG00719
BG00814
BG00974
3
OG0043
0
OG0040
OG002
Intetumumab 10 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
Units
Counts
Participants
OG0003
OG0013
OG0023
Title
Denominators
Categories
Title
Measurements
OG00094.44± 9.037
OG001199.45± 64.093
OG002306.86± 54.979
OG002
Intetumumab 10 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
Units
Counts
Participants
OG0001
OG0011
OG0023
Title
Denominators
Categories
Title
Measurements
OG000257.55± NAStandard deviation was not estimable based on one subject.
OG001503.71± NAStandard deviation was not estimable based on one subject.
OG0021479.07± 149.851
OG002
Intetumumab 10 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
Units
Counts
Participants
OG0001
OG0011
OG0023
Title
Denominators
Categories
Title
Measurements
OG0002.03± NAStandard deviation was not estimable based on one subject.
OG0012.13± NAStandard deviation was not estimable based on one subject.
OG0025.33± 1.001
OG002
Intetumumab 10 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
Units
Counts
Participants
OG0001
OG0011
OG0023
Title
Denominators
Categories
Title
Measurements
OG00011.85± NAStandard deviation was not estimable based on one subject.
OG0019.96± NAStandard deviation was not estimable based on one subject.
OG0026.79± 1.634
OG002
Intetumumab 10 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
Units
Counts
Participants
OG0001
OG0011
OG0023
Title
Denominators
Categories
Title
Measurements
OG00034.69± NAStandard deviation was not estimable based on one subject.
OG00130.63± NAStandard deviation was not estimable based on one subject.
OG00250.80± 4.981
OG002
Intetumumab 10 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG002
Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
OG003
Dacarbazine + Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Units
Counts
Participants
OG00032
OG00132
OG00233
OG00332
Title
Denominators
Categories
Title
Measurements
OG00054.0(41.0 to 85.0)
OG00142.0(39.0 to 43.0)
OG00242.0(40.0 to 48.0)
OG00375.0(43.0 to 121.0)
OG002
Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
OG003
Dacarbazine + Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Units
Counts
Participants
OG00031
OG00131
OG00233
OG00330
Title
Denominators
Categories
Title
Measurements
OG0009.7
OG0010
OG0026.1
OG0033.3
OG002
Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
OG003
Dacarbazine + Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Units
Counts
Participants
OG00031
OG00131
OG00233
OG00330
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG002
Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
OG003
Dacarbazine + Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Units
Counts
Participants
OG00031
OG00131
OG00233
OG00330
Title
Denominators
Categories
Title
Measurements
OG00032.3
OG00125.8
OG00224.2
OG00353.3
OG002
Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
OG003
Dacarbazine + Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Units
Counts
Participants
OG00032
OG00132
OG00233
OG00332
Title
Denominators
Categories
Title
Measurements
OG000233.0(175.0 to 356.0)
OG001298.0(213.0 to 343.0)
OG002426.0(257.0 to 614.0)
OG003333.5(253.0 to 536.0)
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
OG003
Dacarbazine + Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG002
Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
OG003
Dacarbazine + Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Units
Counts
Participants
OG00032
OG00132
OG00233
OG00332
Title
Denominators
Categories
Title
Measurements
OG000135.0(86.0 to NA)The upper limit of 95% confidence interval was not estimable due to inadequate events.
OG001226.0(52.0 to 226.0)
OG002194.0(113.0 to NA)The upper limit of 95% confidence interval was not estimable due to inadequate events.
OG003170.0(110.0 to 395.0)
Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
OG003
Dacarbazine + Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Units
Counts
Participants
OG00031
OG00131
OG00233
OG00332
Title
Denominators
Categories
Title
Measurements
OG000NA± NAParticipants in this group did not receive CNTO 95. Therefore, the data was not available for this group.
OG001131.18± 61.122
OG002240.81± 87.332
OG003219.47± 118.267
OG002
Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
OG003
Dacarbazine + Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Units
Counts
Participants
OG00032
OG00132
OG00233
OG00332
Title
Denominators
Categories
Baseline (Cycle 1) (n=23, 24, 26, 26)
Title
Measurements
OG00053.8± 8.26
OG00155.6± 5.29
OG00255.3± 6.91
OG00353.3± 8.22
Change at Cycle 2 (pre-dose) (n=20, 24, 22, 23)
Title
Measurements
OG000-2.2± 8.13
OG001-1.9± 5.21
OG002-2.9± 5.24
OG003
Change at Cycle 3 (pre-dose) (n = 19, 11, 5, 14)
Title
Measurements
OG000-2.6± 7.18
OG001-1.3± 5.90
OG0020.2± 0.84
OG003
Change at final visit (n = 15, 20, 20, 17)
Title
Measurements
OG000-5.7± 8.79
OG001-5.5± 7.08
OG002-2.2± 4.61
OG003
OG002
Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
OG003
Dacarbazine + Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
Units
Counts
Participants
OG00032
OG00132
OG00233
OG00332
Title
Denominators
Categories
Baseline (Cycle 1) (n=23, 23, 27, 25)
Title
Measurements
OG0001.3± 1.77
OG0012.0± 2.50
OG0020.9± 1.79
OG0032.2± 2.37
Change at Cycle 2 (pre-dose) (n=20, 22, 22, 22)
Title
Measurements
OG0000.9± 1.92
OG0010.0± 1.96
OG0020.5± 2.09
OG003
Change at Cycle 3 (pre-dose) (n = 19, 10, 6, 14)
Title
Measurements
OG0000.5± 2.41
OG0010.5± 1.27
OG0020.0± 0.63
OG003
Change at final visit (n = 15, 20, 20, 16)
Title
Measurements
OG0001.4± 2.85
OG0010.8± 1.80
OG0021.0± 1.96
OG003
Units
Counts
Participants
OG0003
OG0012
Title
Denominators
Categories
Title
Measurements
OG000118.47± 33.462
OG001220.87± 122.662
Units
Counts
Participants
OG0002
OG0011
Title
Denominators
Categories
Title
Measurements
OG000368.74± 36.056
OG001963.17± NAStandard deviation was not estimable based on one subject.
Units
Counts
Participants
OG0002
OG0011
Title
Denominators
Categories
Title
Measurements
OG0002.41± 0.559
OG0012.36± NAStandard deviation was not estimable based on one subject.
Units
Counts
Participants
OG0002
OG0011
Title
Denominators
Categories
Title
Measurements
OG00013.44± 1.537
OG00110.34± NAStandard deviation was not estimable based on one subject.
Units
Counts
Participants
OG0002
OG0011
Title
Denominators
Categories
Title
Measurements
OG00047.38± 16.187
OG00135.18± NAStandard deviation was not estimable based on one subject.
Units
Counts
Participants
OG0000
OG0010
Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
OG002
Intetumumab 10 mg/kg [Phase 1 (Part 1)]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
Units
Counts
Participants
OG0001
OG0011
OG0023
Title
Denominators
Categories
Title
Measurements
OG000257.80± NAStandard deviation was not estimable based on one subject.
OG001503.88± NAStandard deviation was not estimable based on one subject.
OG0021591.54± 213.858
OG002
Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
OG003
Dacarbazine + Intetumumab 10 mg/kg [Phase 2]
Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.