E7050 in Combination With Cetuximab Versus Cetuximab Alon... | NCT01332266 | Trialant
NCT01332266
Sponsor
Eisai Inc.
Status
Completed
Last Update Posted
Jan 3, 2022Actual
Enrollment
95Actual
Phase
Phase 1Phase 2
Conditions
Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck
Interventions
E7050
Cetuximab
Countries
United States
South Korea
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01332266
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
E7050-702
Secondary IDs
ID
Type
Description
Link
2011-000773-31
EudraCT Number
Brief Title
E7050 in Combination With Cetuximab Versus Cetuximab Alone in the Treatment of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck
Official Title
An Open-Label, Multicenter, Randomized, Phase 1b/2 Study of E7050 in Combination With Cetuximab Versus Cetuximab Alone in the Treatment of Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck
Acronym
Not provided
Organization
Eisai Inc.INDUSTRY
Status Module
Record Verification Date
Dec 2017
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
Sep 19, 2011Actual
Primary Completion Date
Jan 31, 2016Actual
Completion Date
Sep 4, 2017Actual
First Submitted Date
Apr 7, 2011
First Submission Date that Met QC Criteria
Apr 8, 2011
First Posted Date
Apr 11, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 14, 2021
Results First Submitted that Met QC Criteria
Dec 3, 2021
Results First Posted Date
Jan 3, 2022Actual
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
Dec 3, 2021
Last Update Posted Date
Jan 3, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eisai Inc.INDUSTRY
Collaborators
Name
Class
PharmaBio Development Inc.
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
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 determine whether participants with platinum-resistant squamous cell carcinoma of the head and neck (SCCHN) who receive either E7050 administered with cetuximab or cetuximab alone experience greater benefit.
Detailed Description
This open-label, multicenter, randomized study will consist of a Phase 1b: a safety run-in period with 3 ascending doses of E7050 in combination with cetuximab; and a Phase 2 portion: a randomized 2-arm period. Approximately 95 participants with platinum-resistant squamous cell carcinoma of the head and neck will be enrolled in the study (10-15 participants in the Phase 1b portion and 80 participants in the Phase 2 portion). Participants will only participate in either the Phase 1b or the Phase 2 portion of the study.
In the Phase 2 portion, participants will receive study treatment (E7050 plus cetuximab or cetuximab alone) for approximately six 28-day cycles (24 weeks). Beyond 24 weeks, participants who are experiencing clinical benefit may continue E7050 plus cetuximab, cetuximab alone or E7050 alone (Arm 1), or may continue cetuximab alone (Arm 2), depending on the original randomization treatment arm, for as long as clinical benefit is sustained and the treatment is well tolerated.
Conditions Module
Conditions
Platinum-Resistant Squamous Cell Carcinoma of the Head and Neck
Phase 2: Arm 1; MTD E7050 + 250 mg cetuximab Arm 2; 250 mg cetuximab
Interventions: Drug cetuximab
Drug: E7050
Drug: Cetuximab
Phase 2
Active Comparator
Phase 2:
Arm 1; MTD E7050 + 250 mg/m2 cetuximab Arm 2; 250 mg/m2 cetuximab
Drug: E7050
Drug: Cetuximab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
E7050
Drug
E7050 given orally at 200, 300, or 400 mg once daily.
Active Comparator; Phase 1b: Cohort 1,2,and 3
Phase 2
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0)
DLT:adverse events graded as NCI CTCAEv4.0 occurring less than or equal to(<=)28 days after treatment.Events as: Non-hematological: 1)Grade greater than or equal to(>=)3 peripheral neuropathy; 2)Grade 3 fatigue or 2 point decline in eastern cooperative oncology group performance status that persisted for greater than(>)7 days; 3)Grade >=3 nausea,vomiting despite optimal antiemetic treatment; 4)Any nonhematologic toxicity of Grade >=3, with exceptions as alopecia,single laboratory values out of normal range,hypersensitivity reaction. Hematological 1)Grade 4 neutropenia lasting >7 days; 2)Febrile neutropenia as fever >=38.5 degree celsius with absolute neutrophil count less than(<)1.0*10^9 per liter(/L); 3)Grade 3 thrombocytopenia with nontraumatic bleeding requiring platelet transfusion; 4)Grade 4 thrombocytopenia with/without nontraumatic bleeding. Other 1)Study drug related death; 2)Toxicity that dose escalation committee believed to be DLT that was not covered by above DLT criteria.
Cycle 1 (Cycle length is equal to [=] 28 days)
Phase 1b: Plasma Concentration of Golvatinib When Given in Combination With Cetuximab
Phase 2: Number of Participants With Grade 3 or Higher Treatment-emergent Adverse Events (TEAEs)
TEAEs are defined as an adverse event that has an onset date, or a worsening in severity from baseline (pre-golvatinib), on or after the first dose of golvatinib. The severity was graded according to CTCAE v4.0. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to adverse event.
Up to 5 years 11 months
Secondary Outcomes
Measure
Description
Time Frame
Phase 2: Progression-free Survival (PFS)
PFS is defined as the time from the date of randomization until the earlier of the following two events: the date of PD or the date of death based on response evaluation criteria in solid tumor (RECIST) v1.1. PD is defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan Meier method. As planned, data for this endpoint was analyzed and collected till primary completion date.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Platinum-resistant (defined as failure to respond to treatment with a platinum agent or recurrence of disease after initial response to platinum within 12 months of completing therapy), locally advanced, recurrent and/or metastatic SCCHN, which is untreatable by surgical resection or radiation therapy
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2
Blood pressure must be well-controlled. Participants must have no history of hypertensive crisis or hypertensive encephalopathy; Adequate end organ function
Exclusion Criteria
Nasopharyngeal tumors
Previously received E7050, anti-angiogenic therapy, or anti-epidermal growth factor receptor (EGFR) therapy (prior anti-angiogenic/EGFR therapy is permitted in Phase 1b only. Prior cetuximab is permitted if administered in combination with radiation
Presence of brain metastases, unless the participant has received adequate treatment at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to randomization
Palliative radiotherapy is not permitted throughout the study period
Clinically significant hemoptysis
Serious non-healing wound, ulcer, or active bone fracture
Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for a major surgical procedure during the course of the study
Clinically significant gastrointestinal bleeding within 6 months prior to first dose.
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
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Tucson
Arizona
85715
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
This study consists of two phases Phase 1b and Phase 2. Phase 1b: 12 participants were enrolled and received the study treatment; Phase 2: 83 participants were enrolled and received the study treatment.
Recruitment Details
Participants took part in the study at 28 investigative sites in the Republic of Korea, Ukraine, United Kingdom, and the United States from 19 September 2011 to 04 September 2017.
Participants with platinum-resistant squamous cell carcinoma of the head and neck (SCCHN) received golvatinib 200 milligram (mg) tablets, orally, once daily (run-in period) and cetuximab 400 milligram per square meter (mg/m^2) intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles for determining maximum tolerated dose (MTD) or Recommended Phase 2 dose (RP2D), until the occurrence of progressive disease (PD), unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Periods
Title
Milestones
Reasons Not Completed
Phase 1b
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
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
Hungary
India
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
Golvatinib
Cetuximab
Drug
Cetuximab is given at an initial dose of 400 mg/m2 given as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a dose of 250 mg/m2 given as a 1-hour IV infusion on Day 8, Day 15, and Day 22 of Cycle 1, and Day 1, Day 8, Day 15, and Day 22 of each subsequent cycle.
Active Comparator; Phase 1b: Cohort 1,2,and 3
Phase 2
Phase 2: Number of Participants With Markedly Abnormal Vital Sign Values
Up to 4 years 4 months
Phase 2: Number of Participants With Markedly Abnormal Physical Examinations Findings
Physical examination was performed and included evaluation of 1) General appearance, 2) Head; Eyes; Ears; Nose; Throat (HEENT), 3) Neck, 4) Heart, 5) Chest (Including Lungs), 6) Abdomen, 7) Extremities, 8) Skin, 9) Lymph Nodes, and 10) neurological status. Here, number of participants with markedly abnormal physical examinations were reported.
Up to 4 years 4 months
Phase 2: Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Values
Up to 4 years 4 months
From the date of randomization until the earlier of the following two events: the date of PD or the date of death (Up to approximately 4 years 4 months)
Phase 2: Percentage of Participants With PFS at Week 12
PFS rate at week 12 is defined as the percentage of participants who were still alive without disease progression at 12 weeks from the date of randomization. PFS is defined as the time from the date of randomization until the earlier of the following two events: the date of PD or the date of death based on RECIST v1.1. PD is defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS rate was estimated and analyzed using Kaplan Meier method.
At Week 12
Phase 2: Time to Progression (TTP)
TTP is defined as the time from the date of randomization until the date of PD based on RECIST v1.1. PD is defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. TTP was estimated and analyzed using Kaplan Meier method. As planned, data for this endpoint was analyzed and collected till primary completion date.
From the date of randomization until the date of PD (Up to approximately 4 years 4 months)
Phase 2: Overall Survival (OS)
OS is defined as the time from the date of randomization until the date of death. OS was analyzed using Kaplan Meier method. As planned, data for this endpoint was analyzed and collected till primary completion date.
From the date of randomization until the date of death (Up to approximately 4 years 4 months)
Phase 2: Percentage of Participants With Overall Response
Overall response rate is defined as percentage of participants with complete response (CR) or partial response (PR) based on RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. As planned, data for this endpoint was analyzed and collected till primary completion date.
From the date of randomization until CR or PR (Up to approximately 4 years 4 months)
Participants with platinum-resistant SCCHN received golvatinib 300 mg tablets, orally, once daily (run-in period) and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles for determining MTD or RP2D, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Participants with platinum-resistant SCCHN received golvatinib 400 mg tablets, orally, once daily (run-in period) and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles for determining MTD or RP2D, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Participants with platinum-resistant SCCHN received golvatinib 400 mg (RP2D) tablets, orally, once daily and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
FG004
Phase 2: Arm 2: Cetuximab 400 mg/m^2
Participants with platinum-resistant SCCHN received cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the Investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
FG0004 subjects
FG0015 subjects
FG0023 subjects
FG0030 subjects
FG0040 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG0004 subjects
FG0015 subjects
FG0023 subjects
FG0030 subjects
FG0040 subjects
Type
Comment
Reasons
Death
FG0003 subjects
FG0013 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Phase 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00342 subjects
FG00441 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00342 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Safety population was defined as all participants enrolled and randomized into Phase 1b and Phase 2, except for those who drop out of study prior to receiving any study treatment, or were without any safety assessments following the first dose of study treatment.
Participants with platinum-resistant SCCHN received golvatinib 200 mg tablets, orally, once daily (run-in period) and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles for determining MTD or RP2D, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Participants with platinum-resistant SCCHN received golvatinib 300 mg tablets, orally, once daily (run-in period) and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles for determining MTD or RP2D, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Participants with platinum-resistant SCCHN received golvatinib 400 mg tablets, orally, once daily (run-in period) and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles for determining MTD or RP2D, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Participants with platinum-resistant SCCHN received golvatinib 400 mg (RP2D) tablets, orally, once daily and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
BG004
Phase 2: Arm 2: Cetuximab 400 mg/m^2
Participants with platinum-resistant SCCHN received cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the Investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0015
BG0023
BG00342
BG00441
BG00595
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
BG00070.0± 8.29
BG00158.8± 12.58
BG00259.3± 5.51
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
ECOG PS is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0=Fully Active (Most Favorable Activity); 1=Restricted activity but ambulatory; 2=Ambulatory but unable to carry out work activities; 3=Limited Self-Care; 4=Completely Disabled, No self-care (Least Favorable Activity); 5=Dead.
Count of Participants
Participants
Title
Denominators
Categories
ECOG: 0 (Fully Active)
Title
Measurements
BG0001
BG001
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
Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0)
DLT:adverse events graded as NCI CTCAEv4.0 occurring less than or equal to(<=)28 days after treatment.Events as: Non-hematological: 1)Grade greater than or equal to(>=)3 peripheral neuropathy; 2)Grade 3 fatigue or 2 point decline in eastern cooperative oncology group performance status that persisted for greater than(>)7 days; 3)Grade >=3 nausea,vomiting despite optimal antiemetic treatment; 4)Any nonhematologic toxicity of Grade >=3, with exceptions as alopecia,single laboratory values out of normal range,hypersensitivity reaction. Hematological 1)Grade 4 neutropenia lasting >7 days; 2)Febrile neutropenia as fever >=38.5 degree celsius with absolute neutrophil count less than(<)1.0*10^9 per liter(/L); 3)Grade 3 thrombocytopenia with nontraumatic bleeding requiring platelet transfusion; 4)Grade 4 thrombocytopenia with/without nontraumatic bleeding. Other 1)Study drug related death; 2)Toxicity that dose escalation committee believed to be DLT that was not covered by above DLT criteria.
Safety population was defined as all participants enrolled and randomized to treatment in study, except for those who drop out of the study prior to receiving any study treatment, or were without any safety assessments following the first dose of study treatment.
Participants with platinum-resistant SCCHN received 200 mg of golvatinib tablets orally, once daily (run-in period) and Cetuximab 400 mg/m^2 as intravenous infusion, once on day 1 of cycle 1, followed by 250 mg/m^2 as intravenous infusion, once on days 8, 15 and 22 of cycle 1 of 28-days treatment cycle for 6 subsequent cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Participants with platinum-resistant SCCHN received 300 mg of golvatinib tablets orally, once daily (run-in period) and Cetuximab 400 mg/m^2 as intravenous infusion, once on day 1 of cycle 1, followed by 250 mg/m^2 as intravenous infusion, once on days 8, 15 and 22 of cycle 1 of 28-days treatment cycle for 6 subsequent cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Participants with platinum-resistant SCCHN received 400 mg of golvatinib tablets orally, once daily (run-in period) and Cetuximab 400 mg/m^2 as intravenous infusion, once on day 1 of cycle 1, followed by 250 mg/m^2 as intravenous infusion, once on days 8, 15 and 22 of cycle 1 of 28-days treatment cycle for 6 subsequent cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Units
Counts
Participants
OG0004
OG0015
OG0023
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
Primary
Phase 1b: Plasma Concentration of Golvatinib When Given in Combination With Cetuximab
Data was not collected and analyzed for this outcome measure because no pharmacokinetic analysis was conducted in this study due to incomplete pharmacokinetic sample bioanalysis due to unresolved queries leading to inadequate calculations and limited data interpretability.
Participants with platinum-resistant SCCHN received 200 mg of golvatinib tablets orally, once daily (run-in period) and Cetuximab 400 mg/m^2 as intravenous infusion, once on day 1 of cycle 1, followed by 250 mg/m^2 as intravenous infusion, once on days 8, 15 and 22 of cycle 1 of 28-days treatment cycle for 6 subsequent cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Participants with platinum-resistant SCCHN received 300 mg of golvatinib tablets orally, once daily (run-in period) and Cetuximab 400 mg/m^2 as intravenous infusion, once on day 1 of cycle 1, followed by 250 mg/m^2 as intravenous infusion, once on days 8, 15 and 22 of cycle 1 of 28-days treatment cycle for 6 subsequent cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Primary
Phase 2: Number of Participants With Grade 3 or Higher Treatment-emergent Adverse Events (TEAEs)
TEAEs are defined as an adverse event that has an onset date, or a worsening in severity from baseline (pre-golvatinib), on or after the first dose of golvatinib. The severity was graded according to CTCAE v4.0. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to adverse event.
Safety population was defined as all participants enrolled and randomized to treatment in study, except for those who drop out of the study prior to receiving any study treatment, or were without any safety assessments following the first dose of study treatment.
Participants with platinum-resistant SCCHN received golvatinib 400 mg (RP2D) tablets, orally, once daily and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Primary
Phase 2: Number of Participants With Markedly Abnormal Vital Sign Values
Safety population was defined as all participants enrolled and randomized to treatment in study, except for those who drop out of the study prior to receiving any study treatment, or were without any safety assessments following the first dose of study treatment.
Participants with platinum-resistant SCCHN received golvatinib 400 mg (RP2D) tablets, orally, once daily and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
OG001
Phase 2: Arm 2: Cetuximab 400 mg/m^2
Participants with platinum-resistant SCCHN received cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the Investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Primary
Phase 2: Number of Participants With Markedly Abnormal Physical Examinations Findings
Physical examination was performed and included evaluation of 1) General appearance, 2) Head; Eyes; Ears; Nose; Throat (HEENT), 3) Neck, 4) Heart, 5) Chest (Including Lungs), 6) Abdomen, 7) Extremities, 8) Skin, 9) Lymph Nodes, and 10) neurological status. Here, number of participants with markedly abnormal physical examinations were reported.
Safety population was defined as all participants enrolled and randomized to treatment in study, except for those who drop out of the study prior to receiving any study treatment, or were without any safety assessments following the first dose of study treatment.
Participants with platinum-resistant SCCHN received golvatinib 400 mg (RP2D) tablets, orally, once daily and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
OG001
Phase 2: Arm 2: Cetuximab 400 mg/m^2
Primary
Phase 2: Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Values
Safety population was defined as all participants enrolled and randomized to treatment in study, except for those who drop out of the study prior to receiving any study treatment, or were without any safety assessments following the first dose of study treatment.
Participants with platinum-resistant SCCHN received golvatinib 400 mg (RP2D) tablets, orally, once daily and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
OG001
Phase 2: Arm 2: Cetuximab 400 mg/m^2
Participants with platinum-resistant SCCHN received cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the Investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Secondary
Phase 2: Progression-free Survival (PFS)
PFS is defined as the time from the date of randomization until the earlier of the following two events: the date of PD or the date of death based on response evaluation criteria in solid tumor (RECIST) v1.1. PD is defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan Meier method. As planned, data for this endpoint was analyzed and collected till primary completion date.
Modified Intent-to-Treat (MITT) analysis set included all participants randomized in the applicable study arm who received any comparator or study drug.
Posted
Median
95% Confidence Interval
weeks
From the date of randomization until the earlier of the following two events: the date of PD or the date of death (Up to approximately 4 years 4 months)
Participants with platinum-resistant SCCHN received golvatinib 400 mg (RP2D) tablets, orally, once daily and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Secondary
Phase 2: Percentage of Participants With PFS at Week 12
PFS rate at week 12 is defined as the percentage of participants who were still alive without disease progression at 12 weeks from the date of randomization. PFS is defined as the time from the date of randomization until the earlier of the following two events: the date of PD or the date of death based on RECIST v1.1. PD is defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS rate was estimated and analyzed using Kaplan Meier method.
MITT analysis set included all participants randomized in the applicable study arm who received any comparator or study drug.
Participants with platinum-resistant SCCHN received golvatinib 400 mg (RP2D) tablets, orally, once daily and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Secondary
Phase 2: Time to Progression (TTP)
TTP is defined as the time from the date of randomization until the date of PD based on RECIST v1.1. PD is defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. TTP was estimated and analyzed using Kaplan Meier method. As planned, data for this endpoint was analyzed and collected till primary completion date.
MITT analysis set included all participants randomized in the applicable study arm who received any comparator or study drug.
Posted
Median
95% Confidence Interval
weeks
From the date of randomization until the date of PD (Up to approximately 4 years 4 months)
Participants with platinum-resistant SCCHN received golvatinib 400 mg (RP2D) tablets, orally, once daily and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
OG001
Secondary
Phase 2: Overall Survival (OS)
OS is defined as the time from the date of randomization until the date of death. OS was analyzed using Kaplan Meier method. As planned, data for this endpoint was analyzed and collected till primary completion date.
MITT analysis set included all participants randomized in the applicable study arm who received any comparator or study drug. Here "Overall number of participants analyzed" signifies participants with events (death).
Posted
Median
95% Confidence Interval
weeks
From the date of randomization until the date of death (Up to approximately 4 years 4 months)
Participants with platinum-resistant SCCHN received golvatinib 400 mg (RP2D) tablets, orally, once daily and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
OG001
Phase 2: Arm 2: Cetuximab 400 mg/m^2
Participants with platinum-resistant SCCHN received cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the Investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Secondary
Phase 2: Percentage of Participants With Overall Response
Overall response rate is defined as percentage of participants with complete response (CR) or partial response (PR) based on RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. As planned, data for this endpoint was analyzed and collected till primary completion date.
MITT analysis set included all participants randomized in the applicable study arm who received any comparator or study drug.
Posted
Number
95% Confidence Interval
percentage of participants
From the date of randomization until CR or PR (Up to approximately 4 years 4 months)
Participants with platinum-resistant SCCHN received golvatinib 400 mg (RP2D) tablets, orally, once daily and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Participants with platinum-resistant SCCHN received golvatinib 200 mg tablets, orally, once daily (run-in period) and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles for determining MTD or RP2D, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Participants with platinum-resistant SCCHN received golvatinib 300 mg tablets, orally, once daily (run-in period) and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles for determining MTD or RP2D, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Participants with platinum-resistant SCCHN received golvatinib 400 mg tablets, orally, once daily (run-in period) and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles for determining MTD or RP2D, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Participants with platinum-resistant SCCHN received golvatinib 400 mg (RP2D) tablets, orally, once daily and cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by cetuximab 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
33
42
15
42
42
42
EG004
Phase 2: Arm 2: Cetuximab 400 mg/m^2
Participants with platinum-resistant SCCHN received cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the Investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
36
41
15
41
38
41
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal Pain
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected42 at risk
EG0040 events0 affected41 at risk
Nausea
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Upper Airway Obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Haemorrhage Subcutaneous
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pericardial Effusion
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Mechanical Ileus
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Oral Cavity Fistula
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Rectal Haemorrhage
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Adverse Drug Reaction
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pyelonephritis Acute
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Staphylococcal Infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Alcohol Poisoning
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Post Procedural Haemorrhage
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Fistula
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pain In Jaw
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Tumour Haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Depressed Level Of Consciousness
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Asphyxia
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Stridor
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal Pain
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG0038 events4 affected42 at risk
EG0041 events1 affected41 at risk
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0029 events2 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0022 events1 affected3 at risk
EG003
Blood Alkaline Phosphatase Increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0014 events3 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Blood Lactate Dehydrogenase Increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0004 events2 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0002 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0022 events2 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0002 events2 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0013 events1 affected5 at risk
EG0022 events2 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Blepharitis
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Chest Pain
General disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0002 events2 affected4 at risk
EG0012 events2 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Dermatitis Acneiform
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0006 events3 affected4 at risk
EG0010 events0 affected5 at risk
EG0023 events2 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0012 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0004 events3 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Face Oedema
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 17.0
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Flushing
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0003 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0002 events2 affected4 at risk
EG0012 events2 affected5 at risk
EG0022 events1 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0012 events2 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0003 events2 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0002 events2 affected4 at risk
EG0010 events0 affected5 at risk
EG0026 events2 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Localised Oedema
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Nasal Ulcer
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Neutrophil Count Decreased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0023 events1 affected3 at risk
EG003
Oedema Peripheral
General disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0023 events2 affected3 at risk
EG003
Paronychia
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Productive Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Protein Total Decreased
Investigations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 17.0
Systematic Assessment
EG0002 events1 affected4 at risk
EG0012 events2 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0023 events2 affected3 at risk
EG003
Skin Fissures
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Skin Ulcer
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Weight Decreased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Mucosal Inflammation
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Rash Maculo-Papular
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Lower Respiratory Tract Infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Oral Pain
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Palmar-Plantar Erythrodysaesthesia Syndrome
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Onychomadesis
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Eastern Cooperative Oncology Group Performance Status Worsened
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Tumour Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Anal pruritus
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Candida infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Oesophageal ulcer
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Otorrhoea
Ear and labyrinth disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG003
Pinguecula
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Substance-induced psychotic disorder
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG003
No pharmacokinetic analysis was conducted in this study due to incomplete pharmacokinetic sample bioanalysis due to unresolved queries leading to inadequate calculations and limited data interpretability.
Participants with platinum-resistant SCCHN received 400 mg of golvatinib tablets orally, once daily (run-in period) and Cetuximab 400 mg/m^2 as intravenous infusion, once on day 1 of cycle 1, followed by 250 mg/m^2 as intravenous infusion, once on days 8, 15 and 22 of cycle 1 of 28-days treatment cycle for 6 subsequent cycles until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG001
Phase 2: Arm 2: Cetuximab 400 mg/m^2
Participants with platinum-resistant SCCHN received cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the Investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Units
Counts
Participants
OG00042
OG00141
Title
Denominators
Categories
Title
Measurements
OG00021
OG00121
Units
Counts
Participants
OG00042
OG00141
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
Participants with platinum-resistant SCCHN received cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the Investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Units
Counts
Participants
OG00042
OG00141
Title
Denominators
Categories
General Appearance
Title
Measurements
OG0005
OG0016
HEENT
Title
Measurements
OG00020
OG00117
Neck
Title
Measurements
OG00024
OG00122
Heart
Title
Measurements
OG0001
OG0010
Chest (Including Lungs)
Title
Measurements
OG0004
OG0015
Abdomen
Title
Measurements
OG0006
OG0013
Extremities
Title
Measurements
OG0002
OG0010
Skin
Title
Measurements
OG0004
OG0015
Lymph Nodes
Title
Measurements
OG00013
OG00115
Neurologic
Title
Measurements
OG0003
OG0015
Units
Counts
Participants
OG00042
OG00141
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG001
Phase 2: Arm 2: Cetuximab 400 mg/m^2
Participants with platinum-resistant SCCHN received cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the Investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Units
Counts
Participants
OG00042
OG00141
Title
Denominators
Categories
Title
Measurements
OG00015.71(12.14 to 23.86)
OG00115.71(9.29 to 18.71)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
0.89
2-Sided
95
0.54
1.46
Superiority
OG001
Phase 2: Arm 2: Cetuximab 400 mg/m^2
Participants with platinum-resistant SCCHN received cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the Investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Units
Counts
Participants
OG00042
OG00141
Title
Denominators
Categories
Title
Measurements
OG00068.9(50.79 to 81.44)
OG00159.4(41.90 to 73.23)
Phase 2: Arm 2: Cetuximab 400 mg/m^2
Participants with platinum-resistant SCCHN received cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After 6 cycles, at the discretion of the Investigator, participants who experienced clinical benefit could continue for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.
Units
Counts
Participants
OG00042
OG00141
Title
Denominators
Categories
Title
Measurements
OG00015.43(12.14 to 23.14)
OG00116.00(9.29 to 19.14)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
1.03
2-Sided
95
0.61
1.73
Superiority
Units
Counts
Participants
OG00033
OG00136
Title
Denominators
Categories
Title
Measurements
OG00039.71(28.43 to 49.71)
OG00136.71(28.00 to 44.43)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
0.85
2-Sided
95
0.53
1.37
Superiority
OG001
Phase 2: Arm 2: Cetuximab 400 mg/m^2
Participants with platinum-resistant squamous cell carcinoma of the head and neck received cetuximab 400 mg/m^2 intravenous infusion, once on Day 1 of Cycle 1, followed by 250 mg/m^2 intravenous infusion, once on Days 8, 15 and 22 of Cycle 1 in a 28-days treatment cycle for up to 6 subsequent cycles. After six cycles, at the discretion of the Investigator, participants experienced clinical benefit have continued for as long as clinical benefit was sustained and the treatment was well tolerated, until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurred first.