Trial Outcomes & Findings for Window of Opportunity Study of VS-6063 (Defactinib) in Surgical Resectable Malignant Pleural Mesothelioma Participants (NCT NCT02004028)
NCT ID: NCT02004028
Last Updated: 2024-02-20
Results Overview
percentage VS-6063 (defactinib)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Cohort 1, From Baseline to Day 12; Cohort 2, From Baseline to Day 35; Cohorts 3, From Baseline to Day 21; Cohorts 3, From Baseline to day 21 day.
Results posted on
2024-02-20
Participant Flow
Participant milestones
| Measure |
Cohort 1 VS-6063 (Defactinib)
Defactinib 400 mg BID for 12 Days
|
Cohort 2
Defactinib 400 mg BID for 35 Days
|
Cohort 3
Defactinib 400 mg BID for 21 Days
|
Cohort 4
Defactinib 100 mg BID for 21 Days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
5
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Window of Opportunity Study of VS-6063 (Defactinib) in Surgical Resectable Malignant Pleural Mesothelioma Participants
Baseline characteristics by cohort
| Measure |
Cohort 1
n=10 Participants
Defactinib 400 mg BID for 12 Days
|
Cohort 2
n=10 Participants
Defactinib 400 mg BID for 35 Days
|
Cohort 3
n=10 Participants
Defactinib 400 mg BID for 21 Days
|
Cohort 4
n=5 Participants
Defactinib 100 mg BID for 21 Days
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
75.9 years
STANDARD_DEVIATION 7.69 • n=5 Participants
|
70.6 years
STANDARD_DEVIATION 9.83 • n=7 Participants
|
71.7 years
STANDARD_DEVIATION 7.29 • n=5 Participants
|
66.6 years
STANDARD_DEVIATION 7.50 • n=4 Participants
|
71.9 years
STANDARD_DEVIATION 8.44 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
5 participants
n=4 Participants
|
35 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Cohort 1, From Baseline to Day 12; Cohort 2, From Baseline to Day 35; Cohorts 3, From Baseline to Day 21; Cohorts 3, From Baseline to day 21 day.percentage VS-6063 (defactinib)
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Defactinib 400 mg BID for 12 Days
|
Cohort 2
n=10 Participants
Defactinib 400 mg BID for 35 Days
|
Cohort 3
n=10 Participants
Defactinib 400 mg BID for 21 Days
|
Cohort 4
n=5 Participants
Defactinib 100 mg BID for 21 Days
|
|---|---|---|---|---|
|
Percentage of pFAK Inhibition in Tumor Tissue
|
NA percentage of pFAK inhibition in a tumor
True baseline sample were not available so post-treatment samples were compared with post-study surgical specimens which was not an accurate baseline measure.
|
NA percentage of pFAK inhibition in a tumor
True baseline sample were not available so post-treatment samples were compared with post-study surgical specimens which was not an accurate baseline measure.
|
85.6 percentage of pFAK inhibition in a tumor
Interval -12.57 to 100.0
|
NA percentage of pFAK inhibition in a tumor
Inhibition of tumor FAK was not included in Cohort 4, as per the protocol.
|
PRIMARY outcome
Timeframe: 0-24 hoursMaximum observed plasma concentration
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Defactinib 400 mg BID for 12 Days
|
Cohort 2
n=9 Participants
Defactinib 400 mg BID for 35 Days
|
Cohort 3
n=9 Participants
Defactinib 400 mg BID for 21 Days
|
Cohort 4
n=5 Participants
Defactinib 100 mg BID for 21 Days
|
|---|---|---|---|---|
|
Evaluate the Pharmacokinetics of VS-6063 (Defactinib), CMax
|
1052 ng/mL
Geometric Coefficient of Variation 126
|
1052 ng/mL
Geometric Coefficient of Variation 126
|
513 ng/mL
Geometric Coefficient of Variation 180
|
517 ng/mL
Geometric Coefficient of Variation 76
|
PRIMARY outcome
Timeframe: 0-8 hoursArea under plasma Concentration (AUC) 0 to t
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Defactinib 400 mg BID for 12 Days
|
Cohort 2
n=9 Participants
Defactinib 400 mg BID for 35 Days
|
Cohort 3
n=9 Participants
Defactinib 400 mg BID for 21 Days
|
Cohort 4
n=5 Participants
Defactinib 100 mg BID for 21 Days
|
|---|---|---|---|---|
|
Evaluate the Pharmacokinetics of VS-6063 (Defactinib), AUC (Area Under the Curve)
|
5280 ng*h/mL
Geometric Coefficient of Variation 136
|
5280 ng*h/mL
Geometric Coefficient of Variation 136
|
2753 ng*h/mL
Geometric Coefficient of Variation 198
|
1891 ng*h/mL
Geometric Coefficient of Variation 69
|
PRIMARY outcome
Timeframe: 0-24 hoursTime to Maximum concentration (Tmax)
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Defactinib 400 mg BID for 12 Days
|
Cohort 2
n=9 Participants
Defactinib 400 mg BID for 35 Days
|
Cohort 3
n=9 Participants
Defactinib 400 mg BID for 21 Days
|
Cohort 4
n=5 Participants
Defactinib 100 mg BID for 21 Days
|
|---|---|---|---|---|
|
Evaluate the Pharmacokinetics of VS-6063 (Defactinib), Median Tmax (h)
|
1 hour
Interval 1.0 to 4.0
|
1 hour
Interval 1.0 to 4.0
|
4 hour
Interval 2.0 to 8.0
|
1 hour
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: Cohort 1, 40 days; Cohort 2, 42 days; Cohort 3, 28 days; Cohort 4, 28 days.Population: Patients with at least one treatment-related treatment-emergent adverse events
Adverse events will be graded by the CTCAE (Common Terminology Criteria for Adverse Events) 4.0 and summarized according to the worst grade observed since the first treatment dose.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Defactinib 400 mg BID for 12 Days
|
Cohort 2
n=10 Participants
Defactinib 400 mg BID for 35 Days
|
Cohort 3
n=10 Participants
Defactinib 400 mg BID for 21 Days
|
Cohort 4
n=5 Participants
Defactinib 100 mg BID for 21 Days
|
|---|---|---|---|---|
|
Number of Patients With at Least One Adverse Event
|
10 Participants
|
10 Participants
|
10 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Cohort 1, 40 days; Cohort 2, 42 days; Cohort 3, 28 days; Cohort 4, 28 days.Modified RECIST criteria for assessment of response in malignant pleural mesothelioma Ann Oncol 2004. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the in the volume of target lesions; Progressive Disease (PD) at least a 20% increase in the volume of target lesions Stable Disease (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.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Defactinib 400 mg BID for 12 Days
|
Cohort 2
n=10 Participants
Defactinib 400 mg BID for 35 Days
|
Cohort 3
n=10 Participants
Defactinib 400 mg BID for 21 Days
|
Cohort 4
n=5 Participants
Defactinib 100 mg BID for 21 Days
|
|---|---|---|---|---|
|
To Evaluate the Tumor Response to VS-6063 (Defactinib)
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Evaluate the Tumor Response to VS-6063 (Defactinib)
Partial Response
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
To Evaluate the Tumor Response to VS-6063 (Defactinib)
Stable Disease
|
9 Participants
|
4 Participants
|
7 Participants
|
2 Participants
|
|
To Evaluate the Tumor Response to VS-6063 (Defactinib)
Progressive Disease
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
To Evaluate the Tumor Response to VS-6063 (Defactinib)
Non-Evaluable
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 2
Serious events: 2 serious events
Other events: 8 other events
Deaths: 1 deaths
Cohort 3
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Cohort 4
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=10 participants at risk
Defactinib 400 mg BID for 12 days
|
Cohort 2
n=10 participants at risk
Defactinib 400 mg BID for 35 days
|
Cohort 3
n=10 participants at risk
Defactinib 400 mg BID for 21 days
|
Cohort 4
n=5 participants at risk
Defactinib 100 mg BID for 21 days
|
|---|---|---|---|---|
|
Investigations
International Normalised Ratio increased
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/5 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
General disorders
Disease progression
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/5 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Infections and infestations
Wound Infection
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/5 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
1/5 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/5 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
1/5 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
Other adverse events
| Measure |
Cohort 1
n=10 participants at risk
Defactinib 400 mg BID for 12 days
|
Cohort 2
n=10 participants at risk
Defactinib 400 mg BID for 35 days
|
Cohort 3
n=10 participants at risk
Defactinib 400 mg BID for 21 days
|
Cohort 4
n=5 participants at risk
Defactinib 100 mg BID for 21 days
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
1/5 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
2/10 • Number of events 3 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/5 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Number of events 3 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
2/10 • Number of events 2 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
40.0%
2/5 • Number of events 2 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Nervous system disorders
Tremor
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/5 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
60.0%
6/10 • Number of events 6 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/5 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
2/10 • Number of events 2 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
80.0%
8/10 • Number of events 8 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
2/10 • Number of events 2 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
1/5 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
2/10 • Number of events 2 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/5 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
1/5 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
2/10 • Number of events 2 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
1/5 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
30.0%
3/10 • Number of events 3 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/5 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Vascular disorders
Hypertension
|
20.0%
2/10 • Number of events 2 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
2/10 • Number of events 2 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/5 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/5 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Injury, poisoning and procedural complications
Injury, poisoning, procedureal complications
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
2/10 • Number of events 5 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
1/5 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Investigations
Weight decreased
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/5 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
20.0%
2/10 • Number of events 2 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/5 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
2/10 • Number of events 2 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
1/5 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
2/10 • Number of events 2 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/5 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
40.0%
4/10 • Number of events 4 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
30.0%
3/10 • Number of events 6 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
30.0%
3/10 • Number of events 3 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/5 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
2/10 • Number of events 2 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/5 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Investigations
International normalised ratio increased
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
2/10 • Number of events 3 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/5 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Gastrointestinal disorders
Abdominal distension
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/5 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • Number of events 2 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
2/10 • Number of events 2 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/5 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
2/10 • Number of events 2 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
40.0%
4/10 • Number of events 4 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/5 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 2 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
30.0%
3/10 • Number of events 4 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
2/10 • Number of events 2 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
1/5 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
2/10 • Number of events 2 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
0.00%
0/10 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
1/5 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 2 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
30.0%
3/10 • Number of events 5 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
1/5 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
40.0%
4/10 • Number of events 4 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
10.0%
1/10 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
20.0%
1/5 • Number of events 1 • Cohort 1, 40 days Cohort 2, 42 days Cohort 3, 28 days Cohort 4, 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place