MSC2015103B in Solid Tumors | NCT01453387 | Trialant
NCT01453387
Sponsor
EMD Serono
Status
Terminated
Last Update Posted
May 8, 2017Actual
Enrollment
28Actual
Phase
Phase 1
Conditions
Advanced Solid Tumor
Interventions
MSC2015103B
MSC2015103B
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
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
NCT01453387
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
EMR 200064-001
Secondary IDs
Not provided
Brief Title
MSC2015103B in Solid Tumors
Official Title
A Phase I Dose-Escalation First-In-Human Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Oral MEK Inhibitor MSC2015103B Administered With Two Different Treatment Schedules in Subjects With Advanced Solid Tumors
Acronym
Not provided
Organization
EMD SeronoINDUSTRY
Status Module
Record Verification Date
Mar 2017
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Due to an administrative reason
Expanded Access Info
No
Start Date
Sep 2011
Primary Completion Date
Jul 2013Actual
Completion Date
Jul 2013Actual
First Submitted Date
Sep 9, 2011
First Submission Date that Met QC Criteria
Oct 12, 2011
First Posted Date
Oct 17, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 8, 2016
Results First Submitted that Met QC Criteria
Mar 27, 2017
Results First Posted Date
May 8, 2017Actual
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
Mar 27, 2017
Last Update Posted Date
May 8, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
EMD SeronoINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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 main purpose of this study is to test the experimental drug, MSC2015103B at different dose levels and on different treatment schedules, to see whether it is safe and can be tolerated when given to subjects once a day one day per week over a 21-day period or once a day three times per week over a 21-day period. The investigators would also like to find out how MSC2015103B is broken down by the body.
Additional purposes of the trial are to assess side effects of MSC2015103B and to find out whether MSC2015103B has anti-cancer effects. In addition, the investigators would like to explore pharmacokinetics.
Detailed Description
Not provided
Conditions Module
Conditions
Advanced Solid Tumor
Keywords
MEK inhibitor
Solid Tumor
Phase I
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
28Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1 - MSC2015103B (Schedule 1)
Experimental
Drug: MSC2015103B
Part 1 - MSC2015103B (Schedule 2)
Experimental
Drug: MSC2015103B
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MSC2015103B
Drug
Schedule 1: MSC2015103B will be administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD establishment. Starting dose will be 150 microgram (mcg), which will be escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Subjects Who Experienced Dose-limiting Toxicities (DLT)
DLT was evaluated using the National cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. DLT was defined as any of the following AEs occurring during Cycle 1 that are not related to progressive disease (PD) at any dose level: Any Grade 3 or more non-hematological toxicity excluding: Grade 3 diarrhea or associated electrolyte abnormalities that were controlled with adequate and optimal therapies, Grade 3 liver function abnormalities which resolved within 7 days, vomiting. Grade 4 neutropenia of greater than (>) 5 days duration or Grade 3 febrile neutropenia, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding, any severe or life threatening AE or any AE or abnormality which impairs daily normal physiological functions, any treatment delay for 2 weeks or more due to adverse effects not related to PD. All events judged to be related by the Investigator to PD were excluded from the DLT definition.
Up to Day 21 of Cycle 1
Percentage of Subjects Who Experienced DLT
DLT was evaluated using the National cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. DLT was defined as any of the following AEs occurring during Cycle 1 that are not related to PD at any dose level: Any Grade 3 or more non-hematological toxicity excluding: Grade 3 diarrhea or associated electrolyte abnormalities that were controlled with adequate and optimal therapies, Grade 3 liver function abnormalities which resolved within 7 days, vomiting. Grade 4 neutropenia of greater than (>) 5 days duration or Grade 3 febrile neutropenia, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding, any severe or life threatening AE or any AE or abnormality which impairs daily normal physiological functions, any treatment delay for 2 weeks or more due to adverse effects not related to PD. All events judged to be related by the Investigator to PD were excluded from the DLT definition.
Up to Day 21 of Cycle 1
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Subjects Who Experienced Any Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation
An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. SAE (Serious adverse event) is defined as any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.. TEAEs are events between first dose of study drug up to the cut-off date (15 July 2013) and were absent before treatment or that worsened relative to pretreatment state.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Pathologically confirmed solid tumor preferably, but not exclusively, including pancreatic, thyroid, colorectal, non-small cell lung, endometrial, renal, breast, ovarian carcinoma, or melanoma which is locally advanced or metastatic, and either refractory after standard therapy for the disease or for which no effective standard therapy is available
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal to (<=) 1
Has read and understands the informed consent form and is willing and able to give informed consent. Fully understands requirements of and willing to comply with all trial visits and assessments
Evidence of measurable disease at trial entry as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.0.
Willing to provide archival tissue samples for molecular analysis
Other inclusion criteria as defined in protocol.
Exclusion Criteria
Bone marrow impairment as evidenced by hemoglobin less than (<) 9.0 gram per deciliter (g/dL), neutrophil count < 1.5 x 10^9 per liter (/L), and/or platelets <100 x 10^9/L per liter (/L)
Renal impairment as evidenced by serum creatinine greater than (>) 1.5 x upper limit of normal (ULN) and/or calculated creatinine clearance < 50 milliliter per minute (mL/min) (Cockcroft-Gault formula)
Liver function and liver cell integrity abnormality as defined by total bilirubin > 1.5 x ULN, or aspartate aminotransferase/alanine aminotransferase (AST/ALT) > 2.5 x ULN, for subjects with liver involvement AST/ALT > 5 x ULN. Subjects with albumin < 2.5 g/dL are also excluded
History of central nervous system (CNS) metastases.
History of difficulty of swallowing, malabsorption, or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the tested product.
Pregnant or nursing females Other exclusion criteria as defined in protocol.
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
Medical Responsible
Merck Serono, a division of Merck KGaA, Darmstadt, Germany
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Beth Israel Deaconess Medical Center
Boston
Massachusetts
United States
Dana-Farber Cancer Institute
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.
Enrolled: 28 subjects were screened for eligibility and all were randomized in to the trial.
Recruitment Details
First/Last subject (informed consent): 09 September 2011/18 April 2013. Study completion date: 15 July 2013, Clinical data cut-off date: 15 July 2013; Subjects were randomized at 3 centers in United States.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1 - MSC2015103B (Schedule 1)
MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until maximum tolerated dose (MTD) was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
FG001
Part 1 - MSC2015103B (Schedule 2)
MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00021 subjects
FG0017 subjects
COMPLETED
FG00021 subjects
FG0017 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
Baseline Characteristics Module
Baseline Analysis Population Description
Safety analysis set included all subjects who received at least one administration of the trial medication.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1 - MSC2015103B (Schedule 1)
MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until maximum tolerated dose (MTD) was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
BG001
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Outcome Measures Module
Outcome Measures
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 Subjects Who Experienced Dose-limiting Toxicities (DLT)
DLT was evaluated using the National cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. DLT was defined as any of the following AEs occurring during Cycle 1 that are not related to progressive disease (PD) at any dose level: Any Grade 3 or more non-hematological toxicity excluding: Grade 3 diarrhea or associated electrolyte abnormalities that were controlled with adequate and optimal therapies, Grade 3 liver function abnormalities which resolved within 7 days, vomiting. Grade 4 neutropenia of greater than (>) 5 days duration or Grade 3 febrile neutropenia, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding, any severe or life threatening AE or any AE or abnormality which impairs daily normal physiological functions, any treatment delay for 2 weeks or more due to adverse effects not related to PD. All events judged to be related by the Investigator to PD were excluded from the DLT definition.
Safety analysis set included all the subjects who received at least one administration of the trial medication.
Posted
Number
Subjects
Up to Day 21 of Cycle 1
Adverse Events Module
Frequency Threshold
0
Time Frame
From the initiation of the trial till data cut-off date (15 July 2013)
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
Part 1 - MSC2015103B (Schedule 1)
MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA Version 15.1
Non-systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 15.1
Non-systematic Assessment
More Info Module
Limitations and Caveats
The study was terminated early during Part 1 of the trial due to administrative reason. Pharmacodynamics evaluations were not performed due to early termination.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Point of Contact
Title
Organization
Phone
Extension
Email
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA
+49-6151-72-5200
service@merckgroup.com
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
No data available
No data is available for this block.
Non-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
Part 1 - MSC2015103B (Schedule 1)
MSC2015103B
Drug
Schedule 2: MSC2015103B will be administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose will be 150 mcg, and will be escalated to 200 mcg subsequently.
Part 1 - MSC2015103B (Schedule 2)
From the initiation of the trial till the data cut-off date 15 July 2013
Percentage of Subjects Who Experienced Clinically Significant Lab Abnormality Judged to be Related to the Trial Medication
Abnormal laboratory findings and other abnormal investigational findings which were associated with clinical signs and symptoms, lead to treatment discontinuation, or considered medically important by the investigator were reported as AEs.
From the initiation of the trial till the data cut-off date 15 July 2013
Number of Subjects Who Experienced Clinically Significant Lab Abnormality Judged to be Related to the Trial Medication
Abnormal laboratory findings and other abnormal investigational findings which were associated with clinical signs and symptoms, lead to treatment discontinuation, or considered medically important by the investigator were reported as AEs.
From the initiation of the trial till the data cut-off date 15 July 2013
Maximum Plasma Concentration (Cmax)
Schedule 1 : 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Days 1 and 17.
Time to Reach Maximum Plasma Concentration (Tmax)
Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17.
Apparent Terminal Half Life (T1/2)
The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination.
Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17.
Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-inf])
The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.
Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17.
AUC Versus Time Curve Within One Dosing Interval (AUC0-tau)
Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17.
Apparent Oral Clearance of the Drug From Plasma (CL/f)
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/f was influenced by the fraction absorbed.
Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1.
Apparent Volume of Distribution Associated to the Terminal Phase (Vz/f)
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed.
Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1.
ERK phosphorylation levels were to be assessed in peripheral blood mononuclear cells (PBMC) during the dose escalation
Schedule 1: Day 1: Pre-dose; Post-dose: 2, 4, 8, 24 hour; 48 or 72 hour; 48 or 96 hour, 168 hour; Day 15: Pre-dose; Schedule 2: Day 1: Pre-dose; Post-dose: 2, 8, 24, 48, 96 hour; Day 15: Pre-dose; Day 17: Pre-dose; Post-dose: 2, 8, and 24 hour
Percentage of Subjects With Overall Response
Overall response was to be confirmed by complete response (CR) or partial response (PR) using response evaluation criteria in solid tumours Version 1.0 (RECIST) during treatment. CR: The disappearance of all target and non-target lesions and normalization of tumor marker level; PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline.
Every 6 Weeks until complete response or till data cut-off date 15 July 2013
Percentage of Subjects With Clinical Benefit
Clinical benefit was to be confirmed by CR, PR or stable disease (SD) lasting at least 6 weeks (using RECIST v1.0) during treatment. CR: The disappearance of all target and non-target lesions and normalization of tumor marker level; PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started.
Every 6 Weeks until complete response or till data cut-off date 15 July 2013
Boston
Massachusetts
United States
Karmanos Cancer Institute
Detroit
Michigan
United States
Part 1 - MSC2015103B (Schedule 2)
MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
BG002
Total
Total of all reporting groups
21
BG0017
BG00228
Subjects
Title
Denominators
Categories
18 to less than (<) 45 years
Title
Measurements
BG0002
BG0010
BG0022
Greater than equal to (>=) 45 to <65 years
Title
Measurements
BG00010
BG0015
BG00215
>=65 years
Title
Measurements
BG0009
BG0012
BG00211
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0014
BG0028
Male
BG00017
BG0013
BG00220
ID
Title
Description
OG000
Part 1 - MSC2015103B (Schedule 1)
MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until maximum tolerated dose (MTD) was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
OG001
Part 1 - MSC2015103B (Schedule 2)
MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
Units
Counts
Participants
OG00021
OG0017
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
Primary
Percentage of Subjects Who Experienced DLT
DLT was evaluated using the National cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. DLT was defined as any of the following AEs occurring during Cycle 1 that are not related to PD at any dose level: Any Grade 3 or more non-hematological toxicity excluding: Grade 3 diarrhea or associated electrolyte abnormalities that were controlled with adequate and optimal therapies, Grade 3 liver function abnormalities which resolved within 7 days, vomiting. Grade 4 neutropenia of greater than (>) 5 days duration or Grade 3 febrile neutropenia, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding, any severe or life threatening AE or any AE or abnormality which impairs daily normal physiological functions, any treatment delay for 2 weeks or more due to adverse effects not related to PD. All events judged to be related by the Investigator to PD were excluded from the DLT definition.
Safety analysis set included all subjects who received at least one administration of the trial medication.
Posted
Number
Percentage of subjects
Up to Day 21 of Cycle 1
ID
Title
Description
OG000
Part 1 - MSC2015103B (Schedule 1)
MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
OG001
Part 1 - MSC2015103B (Schedule 2)
MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
Units
Counts
Participants
OG00021
OG0017
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
Secondary
Percentage of Subjects Who Experienced Any Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation
An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. SAE (Serious adverse event) is defined as any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.. TEAEs are events between first dose of study drug up to the cut-off date (15 July 2013) and were absent before treatment or that worsened relative to pretreatment state.
The safety analysis set included all the subjects who received at least one administration of the trial medication.
Posted
Number
Percentage of subjects
From the initiation of the trial till the data cut-off date 15 July 2013
ID
Title
Description
OG000
Part 1 - MSC2015103B (Schedule 1)
MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
OG001
Part 1 - MSC2015103B (Schedule 2)
MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
Units
Counts
Participants
OG00021
OG0017
Title
Denominators
Categories
TEAEs
Title
Measurements
OG000100.0
OG001100.0
Serious TEAEs
Title
Measurements
OG000
Secondary
Percentage of Subjects Who Experienced Clinically Significant Lab Abnormality Judged to be Related to the Trial Medication
Abnormal laboratory findings and other abnormal investigational findings which were associated with clinical signs and symptoms, lead to treatment discontinuation, or considered medically important by the investigator were reported as AEs.
The safety analysis set included all the subjects who received at least one administration of the trial medication.
Posted
Number
Percentage of subjects
From the initiation of the trial till the data cut-off date 15 July 2013
ID
Title
Description
OG000
Part 1 - MSC2015103B 200 mcg (Schedule 1)
The planned dose of MSC2015103B (150 mcg, 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg) was orally administered once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG001
Part 1 - MSC2015103B (Schedule 2)
The planned dose of MSC2015103B (150 mcg and 200 mcg) was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
Units
Counts
Participants
OG00021
OG0017
Title
Denominators
Categories
Aspartate aminotransferase increased
Title
Measurements
OG00014.3
OG0010.0
Decreased appetite
Title
Measurements
OG000
Secondary
Number of Subjects Who Experienced Clinically Significant Lab Abnormality Judged to be Related to the Trial Medication
Abnormal laboratory findings and other abnormal investigational findings which were associated with clinical signs and symptoms, lead to treatment discontinuation, or considered medically important by the investigator were reported as AEs.
The safety analysis set included all the subjects who received at least one administration of the trial medication.
Posted
Number
Subjects
From the initiation of the trial till the data cut-off date 15 July 2013
ID
Title
Description
OG000
Part 1 - MSC2015103B (Schedule 1)
The planned dose of MSC2015103B (150 mcg, 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg) was orally administered once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG001
Part 1 - MSC2015103B (Schedule 2)
The planned dose of MSC2015103B (150 mcg and 200 mcg) was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
Units
Counts
Participants
OG00021
OG0017
Title
Denominators
Categories
Aspartate aminotransferase increased
Title
Measurements
OG0003
OG0010
Decreased appetite
Title
Measurements
OG000
Secondary
Maximum Plasma Concentration (Cmax)
Pharmacokinetic analysis set included all the subjects who received at least 1 dose of MSC2015103B and provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. "n" signifies the number of subjects evaluable for the particular timepoint.
Posted
Geometric Mean
Full Range
Picogram per milliliter
Schedule 1 : 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Days 1 and 17.
ID
Title
Description
OG000
Part 1 - MSC2015103B 150 mcg (Schedule 1)
MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG001
Part 1 - MSC2015103B 200 mcg (Schedule 1)
MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG002
Part 1 - MSC2015103B 300 mcg (Schedule 1)
MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG003
Part 1 - MSC2015103B 450 mcg (Schedule 1)
MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG004
Part 1 - MSC2015103B 650 mcg (Schedule 1)
MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG005
Part 1 - MSC2015103B 1000 mcg (Schedule 1)
MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG006
Part 1 - MSC2015103B 1500 mcg (Schedule 1)
MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG007
Part 1 - MSC2015103B 150 mcg (Schedule 2)
MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
OG008
Part 1 - MSC2015103B 200 mcg (Schedule 2)
MSC2015103B 200 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
Units
Counts
Participants
OG0003
OG0014
OG0023
OG003
Title
Denominators
Categories
Week 1 (n=3, 4, 3, 3, 3, 3, 2, 3, 4)
Title
Measurements
OG00038.750(25.20 to 58.90)
OG00138.110(25.40 to 56.70)
OG00297.293(34.40 to 179.2)
Secondary
Time to Reach Maximum Plasma Concentration (Tmax)
Pharmacokinetic analysis set included all the subjects who received at least 1 dose of MSC2015103B and provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. "n" signifies the number of subjects evaluable for the particular timepoint.
Posted
Geometric Mean
Full Range
Hour
Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17.
ID
Title
Description
OG000
Part 1 - MSC2015103B 150 mcg (Schedule 1)
MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG001
Part 1 - MSC2015103B 200 mcg (Schedule 1)
MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG002
Part 1 - MSC2015103B 300 mcg (Schedule 1)
MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG003
Part 1 - MSC2015103B 450 mcg (Schedule 1)
MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG004
Part 1 - MSC2015103B 650 mcg (Schedule 1)
MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG005
Part 1 - MSC2015103B 1000 mcg (Schedule 1)
MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG006
Part 1 - MSC2015103B 1500 mcg (Schedule 1)
MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG007
Part 1 - MSC2015103B 150 mcg (Schedule 2)
MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
OG008
Part 1 - MSC2015103B 200 mcg (Schedule 2)
MSC2015103B 200 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
Units
Counts
Participants
OG0003
OG0014
OG0023
OG003
Title
Denominators
Categories
Week 1 (n=3,4,3,3,3,3,2,3,4)
Title
Measurements
OG0002.4478(1.833 to 4.000)
OG0015.2643(4.000 to 8.000)
OG0021.4422(1.000 to 2.000)
Secondary
Apparent Terminal Half Life (T1/2)
The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination.
Pharmacokinetic analysis set included all the subjects who received at least 1 dose of MSC2015103B and provided sufficient plasma concentrations of MSC2015103B measurement after the first dose."n" signifies the number of subjects evaluable for the particular timepoint.
Posted
Geometric Mean
Full Range
Hour
Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17.
ID
Title
Description
OG000
Part 1 - MSC2015103B 150 mcg (Schedule 1)
MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG001
Part 1 - MSC2015103B 200 mcg (Schedule 1)
MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG002
Part 1 - MSC2015103B 300 mcg (Schedule 1)
MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG003
Part 1 - MSC2015103B 450 mcg (Schedule 1)
MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG004
Part 1 - MSC2015103B 650 mcg (Schedule 1)
MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG005
Part 1 - MSC2015103B 1000 mcg (Schedule 1)
MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG006
Part 1 - MSC2015103B 1500 mcg (Schedule 1)
MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG007
Part 1 - MSC2015103B 150 mcg (Schedule 2)
MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
OG008
Part 1 - MSC2015103B 200 mcg (Schedule 2)
MSC2015103B 200 mcg was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
Units
Counts
Participants
OG0003
OG0014
OG0023
OG003
Title
Denominators
Categories
Week 1 (n=3,4,3,3,3,3,2,3,4)
Title
Measurements
OG000134.88(72.76 to 201.9)
OG001115.41(73.51 to 280.2)
OG00255.023(20.85 to 118.7)
Secondary
Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-inf])
The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.
Pharmacokinetic analysis set included all the subjects who have received at least 1 dose of MSC2015103B and provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. "n" signifies the number of subjects evaluable for the particular timepoint.
Posted
Geometric Mean
Full Range
Hour*picogram/milliliter
Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17.
ID
Title
Description
OG000
Part 1 - MSC2015103B 150 mcg (Schedule 1)
MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG001
Part 1 - MSC2015103B 200 mcg (Schedule 1)
MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG002
Part 1 - MSC2015103B 300 mcg (Schedule 1)
MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG003
Part 1 - MSC2015103B 450 mcg (Schedule 1)
MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG004
Part 1 - MSC2015103B 650 mcg (Schedule 1)
MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG005
Part 1 - MSC2015103B 1000 mcg (Schedule 1)
MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG006
Part 1 - MSC2015103B 1500 mcg (Schedule 1)
MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG007
Part 1 - MSC2015103B 150 mcg (Schedule 2)
MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
OG008
Part 1 - MSC2015103B 200 mcg (Schedule 2)
MSC2015103B 200 mcg was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
Units
Counts
Participants
OG0003
OG0014
OG0023
OG003
Title
Denominators
Categories
Week 1 (n=3,4,3,3,3,3,2,3,4)
Title
Measurements
OG0003644.7(1997 to 6477)
OG0013927.4(2513 to 5479)
OG0022249.9(829.0 to 4037)
Secondary
AUC Versus Time Curve Within One Dosing Interval (AUC0-tau)
Pharmacokinetic analysis set included all the subjects who received at least 1 dose of MSC2015103B and provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. "n" signifies the number of subjects evaluable for the particular timepoint.
Posted
Geometric Mean
Full Range
hours*picogram/milliliter
Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17.
ID
Title
Description
OG000
Part 1 - MSC2015103B 150 mcg (Schedule 1)
MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG001
Part 1 - MSC2015103B 200 mcg (Schedule 1)
MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG002
Part 1 - MSC2015103B 300 mcg (Schedule 1)
MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG003
Part 1 - MSC2015103B 450 mcg (Schedule 1)
MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG004
Part 1 - MSC2015103B 650 mcg (Schedule 1)
MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG005
Part 1 - MSC2015103B 1000 mcg (Schedule 1)
MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG006
Part 1 - MSC2015103B 1500 mcg (Schedule 1)
MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG007
Part 1 - MSC2015103B 150 mcg (Schedule 2)
MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
OG008
Part 1 - MSC2015103B 200 mcg (Schedule 2)
MSC2015103B 200 mcg was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
Units
Counts
Participants
OG0003
OG0014
OG0023
OG003
Title
Denominators
Categories
Week 1 (n=3,4,3,3,3,3,2,3,4)
Title
Measurements
OG0002072.8(1549 to 2789)
OG0012381.6(1947 to 3892)
OG0021752.7(725.1 to 3202)
Secondary
Apparent Oral Clearance of the Drug From Plasma (CL/f)
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/f was influenced by the fraction absorbed.
Pharmacokinetic analysis set included all the subjects who have received at least one dose of MSC2015103B and who have provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. "N" signifies the total number of subjects evaluable for this outcome measure.
Posted
Geometric Mean
Full Range
Liter/hour
Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1.
ID
Title
Description
OG000
Part 1 - MSC2015103B 150 mcg (Schedule 1)
MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG001
Part 1 - MSC2015103B 200 mcg (Schedule 1)
MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG002
Part 1 - MSC2015103B 300 mcg (Schedule 1)
MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG003
Part 1 - MSC2015103B 450 mcg (Schedule 1)
MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG004
Part 1 - MSC2015103B 650 mcg (Schedule 1)
MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG005
Part 1 - MSC2015103B 1000 mcg (Schedule 1)
MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG006
Part 1 - MSC2015103B 1500 mcg (Schedule 1)
MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG007
Part 1 - MSC2015103B 150 mcg (Schedule 2)
MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
OG008
Part 1 - MSC2015103B 200 mcg (Schedule 2)
MSC2015103B 200 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
Units
Counts
Participants
OG0003
OG0014
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG00041.156(23.16 to 75.11)
OG00150.924(36.51 to 79.57)
OG002133.34(74.30 to 361.9)
OG003
Secondary
Apparent Volume of Distribution Associated to the Terminal Phase (Vz/f)
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed.
Pharmacokinetic analysis set included all the subjects who received at least 1 dose of MSC2015103B and who provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. "n" signifies the number of subjects evaluable for the particular timepoint.
Posted
Geometric Mean
Full Range
Liter
Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1.
ID
Title
Description
OG000
Part 1 - MSC2015103B 150 mcg (Schedule 1)
MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG001
Part 1 - MSC2015103B 200 mcg (Schedule 1)
MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG002
Part 1 - MSC2015103B 300 mcg (Schedule 1)
MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG003
Part 1 - MSC2015103B 450 mcg (Schedule 1)
MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG004
Part 1 - MSC2015103B 650 mcg (Schedule 1)
MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG005
Part 1 - MSC2015103B 1000 mcg (Schedule 1)
MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG006
Part 1 - MSC2015103B 1500 mcg (Schedule 1)
MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
OG007
Part 1 - MSC2015103B 150 mcg (Schedule 2)
MSC2015103B 150 mcg was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
OG008
Part 1 - MSC2015103B 200 mcg (Schedule 2)
MSC2015103B 200 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
ERK phosphorylation levels were to be assessed in peripheral blood mononuclear cells (PBMC) during the dose escalation
As the trial was terminated early due to administrative reason, it was decided as per Statistical Analysis Plan not to evaluate the biomarker data for this study.
Posted
Schedule 1: Day 1: Pre-dose; Post-dose: 2, 4, 8, 24 hour; 48 or 72 hour; 48 or 96 hour, 168 hour; Day 15: Pre-dose; Schedule 2: Day 1: Pre-dose; Post-dose: 2, 8, 24, 48, 96 hour; Day 15: Pre-dose; Day 17: Pre-dose; Post-dose: 2, 8, and 24 hour
ID
Title
Description
OG000
Part 1 - MSC2015103B (Schedule 1)
MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg.
OG001
Part 1 - MSC2015103B (Schedule 2)
MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg.
Units
Counts
Participants
OG0000
OG0010
Secondary
Percentage of Subjects With Overall Response
Overall response was to be confirmed by complete response (CR) or partial response (PR) using response evaluation criteria in solid tumours Version 1.0 (RECIST) during treatment. CR: The disappearance of all target and non-target lesions and normalization of tumor marker level; PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline.
The efficacy analysis set included all subjects who received at least 1(non-zero) dose of MSC2015103B and had a baseline tumor assessment.
Posted
Number
percentage of subjects
Every 6 Weeks until complete response or till data cut-off date 15 July 2013
ID
Title
Description
OG000
Part 1 - MSC2015103B (Schedule 1)
MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg.
OG001
Part 1 - MSC2015103B (Schedule 2)
MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg.
Units
Counts
Participants
OG00021
OG0017
Title
Denominators
Categories
CR
Title
Measurements
OG0000
OG0010
PR
Title
Measurements
OG000
Secondary
Percentage of Subjects With Clinical Benefit
Clinical benefit was to be confirmed by CR, PR or stable disease (SD) lasting at least 6 weeks (using RECIST v1.0) during treatment. CR: The disappearance of all target and non-target lesions and normalization of tumor marker level; PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started.
The efficacy analysis set included all subjects who received at least 1(non-zero) dose of MSC2015103B and had a baseline tumor assessment.
Posted
Number
percentage of subjects
Every 6 Weeks until complete response or till data cut-off date 15 July 2013
ID
Title
Description
OG000
Part 1 - MSC2015103B (Schedule 1)
MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg.
OG001
Part 1 - MSC2015103B (Schedule 2)
MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg.
Units
Counts
Participants
OG00021
OG0017
Title
Denominators
Categories
Title
Measurements
OG00033.3
OG00128.6
4
21
21
21
EG001
Part 1 - MSC2015103B (Schedule 2)
MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
3
7
7
7
EG0001 affected21 at risk
EG0010 affected7 at risk
Nausea
Gastrointestinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Vomiting
Gastrointestinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Pneumonia
Infections and infestations
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0011 affected7 at risk
Septic shock
Infections and infestations
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Catheter site infection
Infections and infestations
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Haematuria
Renal and urinary disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Nephrolithiasis
Renal and urinary disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Feeding tube complication
Injury, poisoning and procedural complications
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
EG0004 affected21 at risk
EG0011 affected7 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0003 affected21 at risk
EG0010 affected7 at risk
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Bradycardia
Cardiac disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Palpitations
Cardiac disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Sinus tachycardia
Cardiac disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Aortic valve incompetence
Cardiac disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Aortic valve sclerosis
Cardiac disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Tachycardia
Cardiac disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Scleral haemorrhage
Eye disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Eyelid ptosis
Eye disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0005 affected21 at risk
EG0011 affected7 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0002 affected21 at risk
EG0011 affected7 at risk
Constipation
Gastrointestinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0013 affected7 at risk
Dental caries
Gastrointestinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0006 affected21 at risk
EG0010 affected7 at risk
Dry mouth
Gastrointestinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Gingival pain
Gastrointestinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Nausea
Gastrointestinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0003 affected21 at risk
EG0013 affected7 at risk
Retching
Gastrointestinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0002 affected21 at risk
EG0010 affected7 at risk
Stomatitis
Gastrointestinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0002 affected21 at risk
EG0011 affected7 at risk
Vomiting
Gastrointestinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0003 affected21 at risk
EG0011 affected7 at risk
Abdominal tenderness
Gastrointestinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Frequent bowel movements
Gastrointestinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Asthenia
General disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Axillary pain
General disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Breakthrough pain
General disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Chest pain
General disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Early satiety
General disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0011 affected7 at risk
Fatigue
General disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0009 affected21 at risk
EG0012 affected7 at risk
Influenza like illness
General disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0011 affected7 at risk
oedema
General disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Oedema peripheral
General disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0003 affected21 at risk
EG0011 affected7 at risk
Pyrexia
General disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0012 affected7 at risk
Device occlusion
General disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Gait disturbance
General disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Suprapubic pain
General disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Thirst
General disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Bile duct obstruction
Hepatobiliary disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Seasonal allergy
Immune system disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Bronchitis
Infections and infestations
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Laryngitis
Infections and infestations
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Nasopharyngitis
Infections and infestations
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Sepsis
Infections and infestations
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Tooth infection
Infections and infestations
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Tracheobronchitis
Infections and infestations
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0011 affected7 at risk
Catheter site infection
Infections and infestations
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Urinary tract infection
Infections and infestations
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0012 affected7 at risk
Arthropod bite
Injury, poisoning and procedural complications
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Overdose
Injury, poisoning and procedural complications
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Thermal burn
Injury, poisoning and procedural complications
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Excoriation
Injury, poisoning and procedural complications
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Alanine aminotransferase increased
Investigations
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Aspartate aminotransferase increased
Investigations
MedDRA Version 15.1
Non-systematic Assessment
EG0006 affected21 at risk
EG0010 affected7 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA Version 15.1
Non-systematic Assessment
EG0004 affected21 at risk
EG0011 affected7 at risk
Blood creatinine increased
Investigations
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Blood phosphorus decreased
Investigations
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Brain natriuretic peptide increased
Investigations
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Breathe sounds abnormal
Investigations
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Ejection fraction decreased
Investigations
MedDRA Version 15.1
Non-systematic Assessment
EG0002 affected21 at risk
EG0011 affected7 at risk
Gamma-glutamyl transferase increased
Investigations
MedDRA Version 15.1
Non-systematic Assessment
EG0004 affected21 at risk
EG0011 affected7 at risk
Haemoglobin decreased
Investigations
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
International normalised ratio increased
Investigations
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Protein total increased
Investigations
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Weight increased
Investigations
MedDRA Version 15.1
Non-systematic Assessment
EG0004 affected21 at risk
EG0010 affected7 at risk
Blood glucose increased
Investigations
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Electrocardiogram QT prolonged
Investigations
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Weight decreased
Investigations
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0006 affected21 at risk
EG0011 affected7 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0011 affected7 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0002 affected21 at risk
EG0010 affected7 at risk
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0002 affected21 at risk
EG0010 affected7 at risk
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0002 affected21 at risk
EG0011 affected7 at risk
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0011 affected7 at risk
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0002 affected21 at risk
EG0013 affected7 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0002 affected21 at risk
EG0011 affected7 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0013 affected7 at risk
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0011 affected7 at risk
Malnutrition
Metabolism and nutrition disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Backpain
Musculoskeletal and connective tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0002 affected21 at risk
EG0012 affected7 at risk
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0002 affected21 at risk
EG0010 affected7 at risk
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0011 affected7 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0004 affected21 at risk
EG0010 affected7 at risk
Dizziness
Nervous system disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0012 affected7 at risk
Headache
Nervous system disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0002 affected21 at risk
EG0011 affected7 at risk
Neuropathy peripheral
Nervous system disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Tremor
Nervous system disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Anxiety
Psychiatric disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0002 affected21 at risk
EG0010 affected7 at risk
Insomnia
Psychiatric disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0002 affected21 at risk
EG0010 affected7 at risk
Depression
Psychiatric disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Mood altered
Psychiatric disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Dysuria
Renal and urinary disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Proteinuria
Renal and urinary disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Urinary incontinence
Renal and urinary disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0011 affected7 at risk
Hydronephrosis
Renal and urinary disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Hydroureter
Renal and urinary disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Nocturia
Renal and urinary disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Obstructive uropathy
Renal and urinary disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Pollakiuria
Renal and urinary disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Renal failure
Renal and urinary disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Urinary hesitation
Renal and urinary disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Perineal pain
Reproductive system and breast disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0005 affected21 at risk
EG0010 affected7 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0002 affected21 at risk
EG0010 affected7 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0002 affected21 at risk
EG0010 affected7 at risk
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Laryngeal haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0002 affected21 at risk
EG0010 affected7 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0011 affected7 at risk
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0004 affected21 at risk
EG0010 affected7 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0002 affected21 at risk
EG0010 affected7 at risk
Night sweats
Skin and subcutaneous tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Pruritus generalized
Skin and subcutaneous tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Skin haemorrhage
Skin and subcutaneous tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Skin hypopigmentation
Skin and subcutaneous tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Swelling face
Skin and subcutaneous tissue disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Biliary drainage
Surgical and medical procedures
MedDRA Version 15.1
Non-systematic Assessment
EG0000 affected21 at risk
EG0011 affected7 at risk
Hypotension
Vascular disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Hypertension
Vascular disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0010 affected7 at risk
Orthostatic hypotension
Vascular disorders
MedDRA Version 15.1
Non-systematic Assessment
EG0001 affected21 at risk
EG0011 affected7 at risk
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The study as a whole will be published prior to any individual investigator publications. It is required that copies of all papers, abstracts, articles, etc. that contain study data are to be forward to the Sponsor for review 30 days prior to submission for publication.