Trial Outcomes & Findings for Study to Evaluate the Safety and Tolerability of RXC004 in Advanced Malignancies (NCT NCT03447470)
NCT ID: NCT03447470
Last Updated: 2025-01-29
Results Overview
A DLT was defined as an adverse event or abnormal laboratory value. Haematological toxicity of CTCAE grade 4 or higher for more than 4 consecutive days. Grade 3 neutropenia of any duration accompanied by fever 38.5 degrees Celsius or higher. Grade 3 thrombocytopaenia with bleeding. Any other confirmed haematological toxicity CTCAE grade 4 or higher. Non-haematological toxicity CTCAE grade 3 or higher. Any other toxicity that is judged to be a DLT by the Safety Review Committee. An AE resulting in disrupted dosing \>14 days.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
46 participants
Primary outcome timeframe
AE data was collected after each cycle and until 30-day follow-up visit after study exit. The DLT period were assessed from the first dose until the end of 21 days of continuous dosing in each cycle until a Maximum Tolerated Dose (MTD) was identified.
Results posted on
2025-01-29
Participant Flow
Participants were enrolled into one of the modules of the study.
In Module 1, participants enrolled, into 6 arms at different dose levels: 0.5 mg; 1 mg; 1.5 mg; 2 mg; 3 mg; 10 mg. In Module 2, participants enrolled, into 2 arms at different dose levels (1.0 mg and 1.5 mg) of RXC004 in combination with Nivolumab. In Module 3, the enrolled participants received a dose of 2.0 mg of RXC004 at 2 weeks on/1 week off.
Participant milestones
| Measure |
Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg)
Patients were given 0.5 mg RXC004 monitored for Dose Limiting Toxicities.
|
Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg)
Patients were given 1.0 mg RXC004 monitored for Dose Limiting Toxicities.
|
Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg)
Patients were given 1.5 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg)
Patients were given 2.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg)
Patients were given 3.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg)
Patients were given 10.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 2 Arm 1 - RXC004 (1.0 mg) Plus Nivolumab
Patients were given 1.0 mg RXC004 in combination with a standard dose of Nivolumab and monitored for Dose Limiting Toxicities.
|
Module 2 Arm 2 - RXC004 (1.5 mg) Plus Nivolumab
Patients were given 1.5 mg RXC004 in combination with a standard dose of Nivolumab and monitored for Dose Limiting Toxicities.
|
Module 3 - Intermittent Schedules of Monotherapy RXC004
Patients were given RXC004 at 2 mg once a day (QD) for 2 weeks, followed by 1 week off for 21 day treatment cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
7
|
6
|
4
|
1
|
6
|
8
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
7
|
6
|
4
|
1
|
6
|
8
|
7
|
Reasons for withdrawal
| Measure |
Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg)
Patients were given 0.5 mg RXC004 monitored for Dose Limiting Toxicities.
|
Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg)
Patients were given 1.0 mg RXC004 monitored for Dose Limiting Toxicities.
|
Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg)
Patients were given 1.5 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg)
Patients were given 2.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg)
Patients were given 3.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg)
Patients were given 10.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 2 Arm 1 - RXC004 (1.0 mg) Plus Nivolumab
Patients were given 1.0 mg RXC004 in combination with a standard dose of Nivolumab and monitored for Dose Limiting Toxicities.
|
Module 2 Arm 2 - RXC004 (1.5 mg) Plus Nivolumab
Patients were given 1.5 mg RXC004 in combination with a standard dose of Nivolumab and monitored for Dose Limiting Toxicities.
|
Module 3 - Intermittent Schedules of Monotherapy RXC004
Patients were given RXC004 at 2 mg once a day (QD) for 2 weeks, followed by 1 week off for 21 day treatment cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
3
|
0
|
1
|
0
|
3
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
3
|
|
Overall Study
Treatment discontinued
|
3
|
2
|
4
|
6
|
2
|
1
|
2
|
4
|
3
|
Baseline Characteristics
Study to Evaluate the Safety and Tolerability of RXC004 in Advanced Malignancies
Baseline characteristics by cohort
| Measure |
Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg)
n=4 Participants
Patients were given 0.5 mg RXC004 monitored for Dose Limiting Toxicities.
|
Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg)
n=3 Participants
Patients were given 1.0 mg RXC004 monitored for Dose Limiting Toxicities.
|
Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg)
n=7 Participants
Patients were given 1.5 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg)
n=6 Participants
Patients were given 2.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg)
n=4 Participants
Patients were given 3.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg)
n=1 Participants
Patients were given 10.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 2 Arm 1 - RXC004 (1.0 mg) Plus Nivolumab
n=6 Participants
Patients were given 1.0 mg RXC004 in combination with a standard dose of Nivolumab and monitored for Dose Limiting Toxicities.
|
Module 2 Arm 2 - RXC004 (1.5 mg) Plus Nivolumab
n=8 Participants
Patients were given 1.5 mg RXC004 in combination with a standard dose of Nivolumab and monitored for Dose Limiting Toxicities.
|
Intermittent Schedules of Monotherapy RXC004 - Module 3
n=7 Participants
Patients were given RXC004 at 2 mg once a day (QD). Patients were treated for 2 weeks at the same dose, followed by 1 week off for 21 day treatment cycles.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
24 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
22 Participants
n=42 Participants
|
|
Age, Continuous
|
73 Years
n=5 Participants
|
57 Years
n=7 Participants
|
62 Years
n=5 Participants
|
67 Years
n=4 Participants
|
68.5 Years
n=21 Participants
|
59 Years
n=8 Participants
|
46.5 Years
n=8 Participants
|
64.5 Years
n=24 Participants
|
63 Years
n=42 Participants
|
63.2 Years
n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
22 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
24 Participants
n=42 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
40 Participants
n=42 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: AE data was collected after each cycle and until 30-day follow-up visit after study exit. The DLT period were assessed from the first dose until the end of 21 days of continuous dosing in each cycle until a Maximum Tolerated Dose (MTD) was identified.Population: RXC004 monotherapy was evaluated at 6 increasing doses.
A DLT was defined as an adverse event or abnormal laboratory value. Haematological toxicity of CTCAE grade 4 or higher for more than 4 consecutive days. Grade 3 neutropenia of any duration accompanied by fever 38.5 degrees Celsius or higher. Grade 3 thrombocytopaenia with bleeding. Any other confirmed haematological toxicity CTCAE grade 4 or higher. Non-haematological toxicity CTCAE grade 3 or higher. Any other toxicity that is judged to be a DLT by the Safety Review Committee. An AE resulting in disrupted dosing \>14 days.
Outcome measures
| Measure |
Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg)
n=3 Participants
Patients were given 0.5 mg RXC004 monitored for Dose Limiting Toxicities.
|
Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg)
n=3 Participants
Patients were given 1.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg)
n=6 Participants
Patients were given 1.5 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg)
n=6 Participants
Patients were given 2.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg)
n=4 Participants
Patients were given 3.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg)
n=1 Participants
Patients were given 10.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
|---|---|---|---|---|---|---|
|
Module 1 - Safety and Tolerability of RXC004 by Assessment of Whether Any Dose Limiting Toxicities (DLT) Arise From First Dose Until the End of 21 Days of Continuous Dosing:
Patients with any DLT
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Module 1 - Safety and Tolerability of RXC004 by Assessment of Whether Any Dose Limiting Toxicities (DLT) Arise From First Dose Until the End of 21 Days of Continuous Dosing:
Colitis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Module 1 - Safety and Tolerability of RXC004 by Assessment of Whether Any Dose Limiting Toxicities (DLT) Arise From First Dose Until the End of 21 Days of Continuous Dosing:
Diarrhoea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Module 1 - Safety and Tolerability of RXC004 by Assessment of Whether Any Dose Limiting Toxicities (DLT) Arise From First Dose Until the End of 21 Days of Continuous Dosing:
Enteritis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Module 1 - Safety and Tolerability of RXC004 by Assessment of Whether Any Dose Limiting Toxicities (DLT) Arise From First Dose Until the End of 21 Days of Continuous Dosing:
Pancreatitis
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: The DLT period will be assessed from the first dose until the end of 28 days of continuous dosing. This will be completed for each dose level until a Maximum Tolerated Dose (MTD) is identified. Estimated time 12 Months in totalPopulation: RXC004 (at 2 doses) was evaluated in combination with Nivolumab.
A DLT is defined as an adverse event or abnormal laboratory value. Haematological toxicity of CTCAE grade 4 or higher for more than 4 consecutive days. Grade 3 neutropenia of any duration accompanied by fever 38.5 degrees Celsius or higher. Grade 3 thrombocytopaenia with bleeding. Any other confirmed haematological toxicity CTCAE grade 4 or higher. Non-haematological toxicity CTCAE grade 3 or higher. Any other toxicity that is judged to be a DLT by the Safety Review Committee. An AE resulting in disrupted dosing \>14 days. Any grade 3 or higher immune-related adverse events
Outcome measures
| Measure |
Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg)
n=5 Participants
Patients were given 0.5 mg RXC004 monitored for Dose Limiting Toxicities.
|
Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg)
n=6 Participants
Patients were given 1.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg)
Patients were given 1.5 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg)
Patients were given 2.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg)
Patients were given 3.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg)
Patients were given 10.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
|---|---|---|---|---|---|---|
|
Module 2 - Safety and Tolerability of RXC004 in Combination With Nivolumab by Assessment of Whether Any Dose Limiting Toxicities (DLT) Arise From First Dose Until the End of 28 Days of Continuous Dosing.
Patients with any DLT
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Module 2 - Safety and Tolerability of RXC004 in Combination With Nivolumab by Assessment of Whether Any Dose Limiting Toxicities (DLT) Arise From First Dose Until the End of 28 Days of Continuous Dosing.
Drug-induced Liver Injury
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: The assessment period will be from the first dose until the end of 21 days of intermittent dosing or within 7 days of IP discontinuation.Population: RXC004 was evaluated at a dose of 2 mg monotherapy administered as an intermittent schedule of 2 weeks on/1 week off dosing
Haematological toxicity of CTCAE grade 4 or higher present for more than 4 consecutive days. Grade 3 neutropenia of any duration accompanied by fever 38.5 degrees Celsius or higher. Grade 3 thrombocytopaenia with bleeding. Any other confirmed haematological toxicity CTCAE grade 4 or higher. Non-haematological toxicity CTCAE grade 3 or higher. Any other toxicity that is judged to be a DLT by the Safety Review Committee. An AE resulting in disrupted dosing \>14 days. Any grade 3 or higher immune-related adverse events.
Outcome measures
| Measure |
Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg)
n=7 Participants
Patients were given 0.5 mg RXC004 monitored for Dose Limiting Toxicities.
|
Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg)
Patients were given 1.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg)
Patients were given 1.5 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg)
Patients were given 2.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg)
Patients were given 3.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg)
Patients were given 10.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
|---|---|---|---|---|---|---|
|
Module 3 - Safety and Tolerability of RXC004 at Intermittent Dosing Schedule.
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples were analyzed from 0 - 96 hours after administration to evaluate PK parameters on Cycle 0 Day 1.Population: PK parameter AUC (0-24) was analyzed at various dose levels ranging from 0.5 - 10 mg.
Area under the Curve, AUC (0-24) for RXC004 was calculated from the measurement of mean plasma concentration of RXC004 at various time points from 0 - 96 hours following single dose on Cycle 0 Day1.
Outcome measures
| Measure |
Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg)
n=4 Participants
Patients were given 0.5 mg RXC004 monitored for Dose Limiting Toxicities.
|
Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg)
n=3 Participants
Patients were given 1.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg)
n=7 Participants
Patients were given 1.5 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg)
n=6 Participants
Patients were given 2.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg)
n=4 Participants
Patients were given 3.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg)
n=1 Participants
Patients were given 10.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
|---|---|---|---|---|---|---|
|
Module 1 - PK Profile - AUC on Cycle 0 Day 1 (C0D1)
|
138.8 h*ng/ml
Standard Deviation 27.9
|
334.8 h*ng/ml
Standard Deviation 118.8
|
464.9 h*ng/ml
Standard Deviation 223.2
|
552.5 h*ng/ml
Standard Deviation 215.3
|
1350.6 h*ng/ml
Standard Deviation 217.8
|
2702.2 h*ng/ml
|
SECONDARY outcome
Timeframe: Samples were analyzed from 0 - 96 hours after administration to evaluate PK parameters on Cycle 0 Day 1.Population: PK parameter, C24, was analyzed at various dose levels ranging from 0.5 - 10 mg.
Mean Plasma concentration of RXC004 at 24 h post-dose calculated from the measurement of mean RXC004 concentrations at various time points from 0 - 96 hours following single dose on Cycle 0 Day1..
Outcome measures
| Measure |
Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg)
n=4 Participants
Patients were given 0.5 mg RXC004 monitored for Dose Limiting Toxicities.
|
Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg)
n=3 Participants
Patients were given 1.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg)
n=7 Participants
Patients were given 1.5 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg)
n=6 Participants
Patients were given 2.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg)
n=4 Participants
Patients were given 3.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg)
n=1 Participants
Patients were given 10.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
|---|---|---|---|---|---|---|
|
Module 1 - PK Profile - C24 on Cycle 0 Day 1 (C0D1)
|
1.74 ng/ml
Standard Deviation 0.86
|
5.28 ng/ml
Standard Deviation 3.66
|
7.26 ng/ml
Standard Deviation 4.67
|
6.55 ng/ml
Standard Deviation 4.62
|
16.05 ng/ml
Standard Deviation 4.71
|
49.5 ng/ml
|
SECONDARY outcome
Timeframe: Samples were analyzed from 0 - 96 hours after administration to evaluate PK parameters on Cycle 0 Day 1.Population: PK parameter Cmax was analyzed at various dose levels ranging from 0.5 - 10 mg.
Maximum plasma concentration (Cmax) of RXC004 following single dose calculated from the measurement of mean plasma concentration of RXC004 at various time points from 0 - 96 hours following single dose on Cycle 0 Day1..
Outcome measures
| Measure |
Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg)
n=4 Participants
Patients were given 0.5 mg RXC004 monitored for Dose Limiting Toxicities.
|
Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg)
n=3 Participants
Patients were given 1.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg)
n=7 Participants
Patients were given 1.5 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg)
n=6 Participants
Patients were given 2.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg)
n=4 Participants
Patients were given 3.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg)
n=1 Participants
Patients were given 10.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
|---|---|---|---|---|---|---|
|
Module 1 - PK Profile - Cmax on Cycle 0 Day 1 (C0D1)
|
20.58 ng/ml
Standard Deviation 3.07
|
47.77 ng/ml
Standard Deviation 18.68
|
69.59 ng/ml
Standard Deviation 33.1
|
84.03 ng/ml
Standard Deviation 36.83
|
198.50 ng/ml
Standard Deviation 57.81
|
369 ng/ml
|
SECONDARY outcome
Timeframe: Samples were analyzed from 0 - 96 hours after administration to evaluate PK parameters on Cycle 0 Day 1.Population: PK parameter Half-life was analyzed at various dose levels ranging from 0.5 - 10 mg.
Half-life of RXC004 following single dose on Cycle 0 Day1 calculated from the measurement of mean plasma concentration of RXC004 at various time points from 0 - 96 hours following single dose on Cycle 0 Day1..
Outcome measures
| Measure |
Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg)
n=4 Participants
Patients were given 0.5 mg RXC004 monitored for Dose Limiting Toxicities.
|
Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg)
n=3 Participants
Patients were given 1.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg)
n=7 Participants
Patients were given 1.5 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg)
n=6 Participants
Patients were given 2.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg)
n=4 Participants
Patients were given 3.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg)
n=1 Participants
Patients were given 10.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
|---|---|---|---|---|---|---|
|
Module 1 - PK Profile - Half-life From PK Analysis on Cycle 0 Day 1 (C0D1)
|
16.77 hours
Interval 11.8 to 30.2
|
15.04 hours
Interval 8.5 to 21.2
|
16.88 hours
Interval 7.8 to 22.5
|
15.37 hours
Interval 9.9 to 21.2
|
14.44 hours
Interval 11.6 to 26.3
|
20.0 hours
|
SECONDARY outcome
Timeframe: Samples were analyzed from 0 - 48 hours after administration to evaluate PK parameters on Cycle 0 Day 1.Population: PK parameter AUC(0-24) was analyzed at the indicated dose levels.
AUC was calculated from the measurement of mean plasma concentration of RXC004 at various time points from 0 - 48 hours following single dose of RXC004 in combination with Nivolumab on Cycle 0 Day1.
Outcome measures
| Measure |
Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg)
n=6 Participants
Patients were given 0.5 mg RXC004 monitored for Dose Limiting Toxicities.
|
Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg)
n=8 Participants
Patients were given 1.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg)
Patients were given 1.5 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg)
Patients were given 2.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg)
Patients were given 3.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg)
Patients were given 10.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
|---|---|---|---|---|---|---|
|
Module 2 - PK Profile - AUC on Cycle 0 Day 1 (C0D1)
|
303.3 h*ng/ml
Standard Deviation 93.57
|
431.23 h*ng/ml
Standard Deviation 109.63
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples were analyzed from 0 - 48 hours after administration to evaluate PK parameters on Cycle 0 Day 1.Population: PK parameter C24 was analyzed at the indicated dose levels.
Mean Plasma concentration of RXC004 at 24 h post-dose when given in combination with Nivolumab.
Outcome measures
| Measure |
Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg)
n=6 Participants
Patients were given 0.5 mg RXC004 monitored for Dose Limiting Toxicities.
|
Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg)
n=8 Participants
Patients were given 1.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg)
Patients were given 1.5 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg)
Patients were given 2.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg)
Patients were given 3.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg)
Patients were given 10.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
|---|---|---|---|---|---|---|
|
Module 2 - PK Profile - C24 on Cycle 0 Day 1 (C0D1)
|
6.18 ng/ml
Standard Deviation 6.75
|
7.54 ng/ml
Standard Deviation 3.12
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples were analyzed from 0 - 48 hours after administration to evaluate PK parameters on Cycle 0 Day 1.Population: PK parameter Cmax was analyzed at the indicated dose levels.
Maximum plasma concentration (Cmax) of RXC004 following single dose on Cycle 0 Day1 when given in combination with Nivolumab..
Outcome measures
| Measure |
Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg)
n=6 Participants
Patients were given 0.5 mg RXC004 monitored for Dose Limiting Toxicities.
|
Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg)
n=8 Participants
Patients were given 1.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg)
Patients were given 1.5 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg)
Patients were given 2.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg)
Patients were given 3.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg)
Patients were given 10.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
|---|---|---|---|---|---|---|
|
Module 2 - PK Profile - Cmax on Cycle 0 Day 1 (C0D1)
|
49.63 ng/ml
Standard Deviation 13.55
|
50.93 ng/ml
Standard Deviation 18.15
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples were analyzed from 0 - 48 hours after administration to evaluate PK parameters on Cycle 0 Day 1.Population: PK parameter Half-life was analyzed at the indicated dose levels.
Half-life of RXC004 following single dose on Cycle 0 Day1 when given in combination with Nivolumab.
Outcome measures
| Measure |
Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg)
n=5 Participants
Patients were given 0.5 mg RXC004 monitored for Dose Limiting Toxicities.
|
Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg)
n=7 Participants
Patients were given 1.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg)
Patients were given 1.5 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg)
Patients were given 2.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg)
Patients were given 3.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg)
Patients were given 10.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
|---|---|---|---|---|---|---|
|
Module 2 - PK Profile - Half-life From PK Analysis on Cycle 0 Day 1 (C0D1)
|
16.35 hours
Interval 9.9 to 22.1
|
10.31 hours
Interval 7.1 to 14.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples were analyzed from 0 - 48 hours after administration to evaluate PK parameters on Cycle 0 Day 1.Population: PK parameter AUC (0-24) was analyzed at the indicated dose level.
AUC was calculated from the measurement of mean plasma concentration of RXC004 at various time points from 0 - 48 hours following single dose of RXC004
Outcome measures
| Measure |
Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg)
n=7 Participants
Patients were given 0.5 mg RXC004 monitored for Dose Limiting Toxicities.
|
Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg)
Patients were given 1.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg)
Patients were given 1.5 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg)
Patients were given 2.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg)
Patients were given 3.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg)
Patients were given 10.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
|---|---|---|---|---|---|---|
|
Module 3 - PK Profile - AUC on Cycle 0 Day 1 (C0D1)
|
547.51 h*ng/ml
Standard Deviation 160.18
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples were analyzed from 0 - 48 hours after administration to evaluate PK parameters on Cycle 0 Day 1.Population: PK parameter C24 was analyzed at the indicated dose level.
Mean Plasma concentration of RXC004 at 24 h post-dose
Outcome measures
| Measure |
Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg)
n=7 Participants
Patients were given 0.5 mg RXC004 monitored for Dose Limiting Toxicities.
|
Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg)
Patients were given 1.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg)
Patients were given 1.5 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg)
Patients were given 2.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg)
Patients were given 3.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg)
Patients were given 10.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
|---|---|---|---|---|---|---|
|
Module 3 - PK Profile - C24 on Cycle 0 Day 1 (C0D1)
|
7.65 ng/ml
Standard Deviation 3.6
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples were analyzed from 0 - 48 hours after administration to evaluate PK parameters on Cycle 0 Day 1.Population: PK parameter Cmax was analyzed at the indicated dose level.
Maximum plasma concentration (Cmax) of RXC004 following single dose
Outcome measures
| Measure |
Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg)
n=7 Participants
Patients were given 0.5 mg RXC004 monitored for Dose Limiting Toxicities.
|
Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg)
Patients were given 1.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg)
Patients were given 1.5 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg)
Patients were given 2.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg)
Patients were given 3.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg)
Patients were given 10.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
|---|---|---|---|---|---|---|
|
Module 3 - PK Profile - Cmax on Cycle 0 Day 1 (C0D1)
|
84.87 ng/ml
Standard Deviation 34.56
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 0 Day 1Population: Samples were analyzed from 0 - 48 hours after administration to evaluate PK parameters on Cycle 0 Day 1.
Half-life of RXC004 following single dose.
Outcome measures
| Measure |
Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg)
n=7 Participants
Patients were given 0.5 mg RXC004 monitored for Dose Limiting Toxicities.
|
Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg)
Patients were given 1.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg)
Patients were given 1.5 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg)
Patients were given 2.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg)
Patients were given 3.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg)
Patients were given 10.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
|---|---|---|---|---|---|---|
|
Module 3 - PK Profile - Half-life on Cycle 0 Day 1 (C0D1)
|
10.5 hours
Interval 8.8 to 14.9
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg)
Serious events: 5 serious events
Other events: 0 other events
Deaths: 3 deaths
Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg)
Serious events: 3 serious events
Other events: 0 other events
Deaths: 1 deaths
Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Module 2 Arm 1 - RXC004 (1.0 mg) Plus Nivolumab
Serious events: 4 serious events
Other events: 0 other events
Deaths: 3 deaths
Module 2 Arm 2 - RXC004 (1.5 mg) Plus Nivolumab
Serious events: 4 serious events
Other events: 0 other events
Deaths: 3 deaths
Intermittent Schedules of Monotherapy RXC004 - Module 3
Serious events: 4 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Module 1 Arm 1 - Monotherapy RXC004 (0.5 mg)
n=4 participants at risk
Patients were given 0.5 mg RXC004 monitored for Dose Limiting Toxicities.
|
Module 1 Arm 2 - Monotherapy RXC004 (1.0 mg)
n=3 participants at risk
Patients were given 1.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 3 - Monotherapy RXC004 (1.5 mg)
n=7 participants at risk
Patients were given 1.5 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 4 - Monotherapy RXC004 (2.0 mg)
n=6 participants at risk
Patients were given 2.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 5 - Monotherapy RXC004 (3.0 mg)
n=4 participants at risk
Patients were given 3.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 1 Arm 6 - Monotherapy RXC004 (10.0 mg)
n=1 participants at risk
Patients were given 10.0 mg RXC004 and monitored for Dose Limiting Toxicities.
|
Module 2 Arm 1 - RXC004 (1.0 mg) Plus Nivolumab
n=6 participants at risk
Patients were given 1.0 mg RXC004 in combination with a standard dose of Nivolumab and monitored for Dose Limiting Toxicities.
|
Module 2 Arm 2 - RXC004 (1.5 mg) Plus Nivolumab
n=8 participants at risk
Patients were given 1.5 mg RXC004 in combination with a standard dose of Nivolumab and monitored for Dose Limiting Toxicities.
|
Intermittent Schedules of Monotherapy RXC004 - Module 3
n=7 participants at risk
Patients were given RXC004 at 2 mg once a day (QD). Patients were treated for 2 weeks at the same dose, followed by 1 week off for 21 day treatment cycles.
RXC004: RXC004 taken orally, inhibits porcupine (PORCN) and interacts with the wnt signaling pathway.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Lung Infection/Pneumonia
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
12.5%
1/8 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
14.3%
1/7 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/8 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
28.6%
2/7 • Number of events 2 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/8 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
14.3%
1/7 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Infections and infestations
Lower respiratory infection
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
12.5%
1/8 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
14.3%
1/7 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
14.3%
1/7 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
100.0%
1/1 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
12.5%
1/8 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
25.0%
1/4 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/8 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
25.0%
1/4 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/8 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
14.3%
1/7 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/8 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
25.0%
1/4 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/8 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
14.3%
1/7 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/8 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Infections and infestations
Escherichia Urinary tract infection
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
14.3%
1/7 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/8 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
33.3%
1/3 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/8 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
16.7%
1/6 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/8 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
16.7%
1/6 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/8 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
16.7%
1/6 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/8 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
12.5%
1/8 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
16.7%
1/6 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/8 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
16.7%
1/6 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/8 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
16.7%
1/6 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/8 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
16.7%
1/6 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/8 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
25.0%
1/4 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/8 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
25.0%
1/4 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/8 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
14.3%
1/7 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/8 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
14.3%
1/7 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/8 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
12.5%
1/8 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
|
Infections and infestations
Infection
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/3 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/6 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/4 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
16.7%
1/6 • Number of events 1 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/8 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
0.00%
0/7 • AE data was collected after each cycle and until 30-day follow-up visit after the last dose or study exit. The median duration of exposure for Module 1 was 7.0 weeks across all dose cohorts. For Module 2 - 7.1 weeks in the 1.0 mg group and 8.4 weeks in the 1.5 mg group; Module 3 - 5.0 weeks.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place