Trial Outcomes & Findings for A Study of [14 C]-Pevonedistat in Participants With Advanced Solid Tumors (NCT NCT03057366)
NCT ID: NCT03057366
Last Updated: 2019-11-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
8 participants
Primary outcome timeframe
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Results posted on
2019-11-18
Participant Flow
Participants took part in the study at 1 investigative site in Hungary from 11 May 2017 to 05 November 2018.
Participants with advanced solid tumors were enrolled in this two-part study to receive intravenous infusion of pevonedistat in Part A and pevonedistat in combination with chemotherapy in Part B (optional part). One participant from Part A consented for Part B but did not meet the eligibility criteria and never received study treatment in Part B.
Participant milestones
| Measure |
Part A: [14C]-Pevonedistat 25 mg/m^2
\[14C\]-pevonedistat (containing approximately 60-98 microcurie \[mCi\] \[approximately 2.22-3.626 megabecquerel (MBq)\] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A.
|
Part B: Pevonedistat + Paclitaxel and Carboplatin
Pevonedistat 20 mg/m\^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m\^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
Part B: Pevonedistat + Docetaxel
Pevonedistat 25 mg/m\^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|---|
|
Part A
STARTED
|
8
|
0
|
0
|
|
Part A
COMPLETED
|
8
|
0
|
0
|
|
Part A
NOT COMPLETED
|
0
|
0
|
0
|
|
Part B
STARTED
|
0
|
5
|
2
|
|
Part B
COMPLETED
|
0
|
5
|
2
|
|
Part B
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The safety analysis set is defined as all enrolled participants who received at least 1 dose of \[14C\]-pevonedistat during Part A.
Baseline characteristics by cohort
| Measure |
[14C]-Pevonedistat 25 mg/m^2
n=8 Participants
\[14C\]-pevonedistat (containing approximately 60-98 mCi \[approximately 2.22-3.626 MBq\] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A. Participants who completed Part A and provided consent for Part B continued treatment in Part B. Participants received pevonedistat 20 mg/m\^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m\^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles); or pevonedistat 25 mg/m\^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the chemotherapies in Part B.
|
|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 13.22 • n=93 Participants • The safety analysis set is defined as all enrolled participants who received at least 1 dose of \[14C\]-pevonedistat during Part A.
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants • The safety analysis set for Part A is defined as all enrolled participants who received at least 1 dose of \[14C\]-pevonedistat during Part A. All safety analyses in Part A was performed using the safety population for Part A.
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants • The safety analysis set for Part A is defined as all enrolled participants who received at least 1 dose of \[14C\]-pevonedistat during Part A. All safety analyses in Part A was performed using the safety population for Part A.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants • The safety analysis set for Part A is defined as all enrolled participants who received at least 1 dose of \[14C\]-pevonedistat during Part A. All safety analyses in Part A was performed using the safety population for Part A.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants • The safety analysis set for Part A is defined as all enrolled participants who received at least 1 dose of \[14C\]-pevonedistat during Part A. All safety analyses in Part A was performed using the safety population for Part A.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants • The safety analysis set for Part A is defined as all enrolled participants who received at least 1 dose of \[14C\]-pevonedistat during Part A. All safety analyses in Part A was performed using the safety population for Part A.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants • The safety analysis set for Part A is defined as all enrolled participants who received at least 1 dose of \[14C\]-pevonedistat during Part A. All safety analyses in Part A was performed using the safety population for Part A.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants • The safety analysis set for Part A is defined as all enrolled participants who received at least 1 dose of \[14C\]-pevonedistat during Part A. All safety analyses in Part A was performed using the safety population for Part A.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants • The safety analysis set for Part A is defined as all enrolled participants who received at least 1 dose of \[14C\]-pevonedistat during Part A. All safety analyses in Part A was performed using the safety population for Part A.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants • The safety analysis set for Part A is defined as all enrolled participants who received at least 1 dose of \[14C\]-pevonedistat during Part A. All safety analyses in Part A was performed using the safety population for Part A.
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants • The safety analysis set for Part A is defined as all enrolled participants who received at least 1 dose of \[14C\]-pevonedistat during Part A. All safety analyses in Part A was performed using the safety population for Part A.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants • The safety analysis set for Part A is defined as all enrolled participants who received at least 1 dose of \[14C\]-pevonedistat during Part A. All safety analyses in Part A was performed using the safety population for Part A.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants • The safety analysis set for Part A is defined as all enrolled participants who received at least 1 dose of \[14C\]-pevonedistat during Part A. All safety analyses in Part A was performed using the safety population for Part A.
|
|
Region of Enrollment
Hungary
|
8 Participants
n=93 Participants • The safety analysis set for Part A is defined as all enrolled participants who received at least 1 dose of \[14C\]-pevonedistat during Part A. All safety analyses in Part A was performed using the safety population for Part A.
|
|
Weight
|
82.38 kilogram (kg)
STANDARD_DEVIATION 15.777 • n=93 Participants • The safety analysis set for Part A is defined as all enrolled participants who received at least 1 dose of \[14C\]-pevonedistat during Part A. All safety analyses in Part A was performed using the safety population for Part A.
|
|
Height
|
165.9 centimeter (cm)
STANDARD_DEVIATION 8.85 • n=93 Participants • The safety analysis set for Part A is defined as all enrolled participants who received at least 1 dose of \[14C\]-pevonedistat during Part A. All safety analyses in Part A was performed using the safety population for Part A.
|
|
Body Mass Index (BMI)
|
29.58 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 4.674 • n=93 Participants • The safety analysis set for Part A is defined as all enrolled participants who received at least 1 dose of \[14C\]-pevonedistat during Part A. All safety analyses in Part A was performed using the safety population for Part A.
|
|
Body Surface Area (BSA)
|
1.943 square meter (m^2)
STANDARD_DEVIATION 0.2195 • n=93 Participants • The safety analysis set for Part A is defined as all enrolled participants who received at least 1 dose of \[14 C\]-pevonedistat during Part A. All safety analyses in Part A was performed using the safety population for Part A.
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The pharmacokinetic (PK) evaluable population included all enrolled participants who received the protocol-specified single \[14C\]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.
Outcome measures
| Measure |
Part A: [14C]-Pevonedistat 25 mg/m^2
n=7 Participants
\[14C\]-pevonedistat (containing approximately 60-98 mCi \[approximately 2.22-3.626 MBq\] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A.
|
Part B: Pevonedistat + Paclitaxel and Carboplatin
Pevonedistat 20 mg/m\^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m\^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
Part B: Pevonedistat + Docetaxel
Pevonedistat 25 mg/m\^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|---|
|
Part A: Cmax: Maximum Observed Plasma and Whole Blood Concentration for Pevonedistat
Plasma
|
234.3 nanogram per milliliter (ng/mL)
Standard Deviation 99.52
|
—
|
—
|
|
Part A: Cmax: Maximum Observed Plasma and Whole Blood Concentration for Pevonedistat
Whole blood
|
6862.9 nanogram per milliliter (ng/mL)
Standard Deviation 1595.22
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The PK evaluable population included all enrolled participants who received the protocol-specified single \[14C\]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.
Outcome measures
| Measure |
Part A: [14C]-Pevonedistat 25 mg/m^2
n=7 Participants
\[14C\]-pevonedistat (containing approximately 60-98 mCi \[approximately 2.22-3.626 MBq\] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A.
|
Part B: Pevonedistat + Paclitaxel and Carboplatin
Pevonedistat 20 mg/m\^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m\^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
Part B: Pevonedistat + Docetaxel
Pevonedistat 25 mg/m\^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|---|
|
Part A: Tmax: Time to Reach the Maximum Plasma and Whole Blood Concentration (Cmax) for Pevonedistat
Plasma
|
0.980 hour
Interval 0.95 to 1.5
|
—
|
—
|
|
Part A: Tmax: Time to Reach the Maximum Plasma and Whole Blood Concentration (Cmax) for Pevonedistat
Whole Blood
|
1.000 hour
Interval 0.98 to 1.53
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The PK evaluable population included all enrolled participants who received the protocol-specified single \[14C\]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.
Outcome measures
| Measure |
Part A: [14C]-Pevonedistat 25 mg/m^2
n=7 Participants
\[14C\]-pevonedistat (containing approximately 60-98 mCi \[approximately 2.22-3.626 MBq\] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A.
|
Part B: Pevonedistat + Paclitaxel and Carboplatin
Pevonedistat 20 mg/m\^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m\^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
Part B: Pevonedistat + Docetaxel
Pevonedistat 25 mg/m\^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|---|
|
Part A: AUClast: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Pevonedistat
Plasma
|
1446.9 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 374.46
|
—
|
—
|
|
Part A: AUClast: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Pevonedistat
Whole Blood
|
59284.0 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 10035.58
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The PK evaluable population included all enrolled participants who received the protocol-specified single \[14C\]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.
Outcome measures
| Measure |
Part A: [14C]-Pevonedistat 25 mg/m^2
n=7 Participants
\[14C\]-pevonedistat (containing approximately 60-98 mCi \[approximately 2.22-3.626 MBq\] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A.
|
Part B: Pevonedistat + Paclitaxel and Carboplatin
Pevonedistat 20 mg/m\^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m\^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
Part B: Pevonedistat + Docetaxel
Pevonedistat 25 mg/m\^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|---|
|
Part A: Cmax: Maximum Observed Plasma and Whole Blood TRA Concentration for [14C]-Pevonedistat Drug-related Material
Plasma
|
293.6 nanogram equivalent per milliliter
Standard Deviation 113.17
|
—
|
—
|
|
Part A: Cmax: Maximum Observed Plasma and Whole Blood TRA Concentration for [14C]-Pevonedistat Drug-related Material
Whole Blood
|
7336.6 nanogram equivalent per milliliter
Standard Deviation 1270.99
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The PK evaluable population included all enrolled participants who received the protocol-specified single \[14C\]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.
Outcome measures
| Measure |
Part A: [14C]-Pevonedistat 25 mg/m^2
n=7 Participants
\[14C\]-pevonedistat (containing approximately 60-98 mCi \[approximately 2.22-3.626 MBq\] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A.
|
Part B: Pevonedistat + Paclitaxel and Carboplatin
Pevonedistat 20 mg/m\^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m\^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
Part B: Pevonedistat + Docetaxel
Pevonedistat 25 mg/m\^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|---|
|
Part A: Tmax: Time to Reach the Maximum Plasma and Whole Blood TRA Concentration (Cmax) for [14C]-Pevonedistat Drug-related Material
Plasma
|
0.980 hour
Interval 0.95 to 1.5
|
—
|
—
|
|
Part A: Tmax: Time to Reach the Maximum Plasma and Whole Blood TRA Concentration (Cmax) for [14C]-Pevonedistat Drug-related Material
Whole Blood
|
0.980 hour
Interval 0.98 to 2.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The PK evaluable population included all enrolled participants who received the protocol-specified single \[14C\]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.
Outcome measures
| Measure |
Part A: [14C]-Pevonedistat 25 mg/m^2
n=7 Participants
\[14C\]-pevonedistat (containing approximately 60-98 mCi \[approximately 2.22-3.626 MBq\] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A.
|
Part B: Pevonedistat + Paclitaxel and Carboplatin
Pevonedistat 20 mg/m\^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m\^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
Part B: Pevonedistat + Docetaxel
Pevonedistat 25 mg/m\^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|---|
|
Part A: AUClast: Area Under the Plasma and Whole Blood TRA Concentration Curve From Time 0 to Time of the Last Quantifiable Concentration for [14C]-Pevonedistat Drug-related Material
Plasma
|
3547.3 hour*nanogram equivalent per milliliter
Standard Deviation 1106.56
|
—
|
—
|
|
Part A: AUClast: Area Under the Plasma and Whole Blood TRA Concentration Curve From Time 0 to Time of the Last Quantifiable Concentration for [14C]-Pevonedistat Drug-related Material
Whole Blood
|
133259.0 hour*nanogram equivalent per milliliter
Standard Deviation 32678.72
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The PK evaluable population included all enrolled participants who received the protocol-specified single \[14C\]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.
Outcome measures
| Measure |
Part A: [14C]-Pevonedistat 25 mg/m^2
n=7 Participants
\[14C\]-pevonedistat (containing approximately 60-98 mCi \[approximately 2.22-3.626 MBq\] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A.
|
Part B: Pevonedistat + Paclitaxel and Carboplatin
Pevonedistat 20 mg/m\^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m\^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
Part B: Pevonedistat + Docetaxel
Pevonedistat 25 mg/m\^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|---|
|
Part A: Aeurine,14C: Cumulative Amount of [14C]-Pevonedistat Excreted in Urine up to the Last Sampling Interval
|
19661.05 microgram equivalent (mcg eq)
Standard Deviation 4099.981
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The PK evaluable population included all enrolled participants who received the protocol-specified single \[14C\]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.
Outcome measures
| Measure |
Part A: [14C]-Pevonedistat 25 mg/m^2
n=7 Participants
\[14C\]-pevonedistat (containing approximately 60-98 mCi \[approximately 2.22-3.626 MBq\] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A.
|
Part B: Pevonedistat + Paclitaxel and Carboplatin
Pevonedistat 20 mg/m\^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m\^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
Part B: Pevonedistat + Docetaxel
Pevonedistat 25 mg/m\^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|---|
|
Part A: Aefeces,14C: Cumulative Amount of [14C]-Pevonedistat Excreted in Feces up to the Last Sampling Interval
|
25029.45 mcg eq
Standard Deviation 4333.04
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The PK evaluable population included all enrolled participants who received the protocol-specified single \[14C\]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.
Outcome measures
| Measure |
Part A: [14C]-Pevonedistat 25 mg/m^2
n=7 Participants
\[14C\]-pevonedistat (containing approximately 60-98 mCi \[approximately 2.22-3.626 MBq\] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A.
|
Part B: Pevonedistat + Paclitaxel and Carboplatin
Pevonedistat 20 mg/m\^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m\^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
Part B: Pevonedistat + Docetaxel
Pevonedistat 25 mg/m\^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|---|
|
Part A: Aetotal,14C: Total Cumulative Excretion of [14C]-Pevonedistat From the Body
|
44690.50 mcg eq
Standard Deviation 2090.833
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The PK evaluable population included all enrolled participants who received the protocol-specified single \[14C\]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.
Outcome measures
| Measure |
Part A: [14C]-Pevonedistat 25 mg/m^2
n=7 Participants
\[14C\]-pevonedistat (containing approximately 60-98 mCi \[approximately 2.22-3.626 MBq\] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A.
|
Part B: Pevonedistat + Paclitaxel and Carboplatin
Pevonedistat 20 mg/m\^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m\^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
Part B: Pevonedistat + Docetaxel
Pevonedistat 25 mg/m\^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|---|
|
Part A: Aeurine: Cumulative Amount of Pevonedistat Dose Excreted in Urine at 144-168 Hours Post-dose
|
1161.47 microgram (mcg)
Standard Deviation 266.413
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The PK evaluable population included all enrolled participants who received the protocol-specified single \[14C\]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.
Outcome measures
| Measure |
Part A: [14C]-Pevonedistat 25 mg/m^2
n=7 Participants
\[14C\]-pevonedistat (containing approximately 60-98 mCi \[approximately 2.22-3.626 MBq\] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A.
|
Part B: Pevonedistat + Paclitaxel and Carboplatin
Pevonedistat 20 mg/m\^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m\^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
Part B: Pevonedistat + Docetaxel
Pevonedistat 25 mg/m\^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|---|
|
Part A: Feurine: Cumulative Percentage of Pevonedistat Dose Excreted in Urine at 144-168 Hours Post-dose
|
2.45 percentage of dose
Standard Deviation 0.548
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dosePopulation: The PK evaluable population included all enrolled participants who received the protocol-specified single \[14C\]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.
Outcome measures
| Measure |
Part A: [14C]-Pevonedistat 25 mg/m^2
n=7 Participants
\[14C\]-pevonedistat (containing approximately 60-98 mCi \[approximately 2.22-3.626 MBq\] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A.
|
Part B: Pevonedistat + Paclitaxel and Carboplatin
Pevonedistat 20 mg/m\^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m\^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
Part B: Pevonedistat + Docetaxel
Pevonedistat 25 mg/m\^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|---|
|
Part A: Renal Clearance (CLR) for Pevonedistat
|
0.8343 liter per hour (L/hr)
Standard Deviation 0.27889
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: From first dose of study drug in Part A up to Day 31; Part B: From first dose of study drug in Part B up to Cycle 11 Day 35 (Cycle length is equal to [=] 21 days)Population: The safety analysis set is defined as all enrolled participants who received at least 1 dose of \[14C\]-pevonedistat during Part A.
Outcome measures
| Measure |
Part A: [14C]-Pevonedistat 25 mg/m^2
n=8 Participants
\[14C\]-pevonedistat (containing approximately 60-98 mCi \[approximately 2.22-3.626 MBq\] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A.
|
Part B: Pevonedistat + Paclitaxel and Carboplatin
n=5 Participants
Pevonedistat 20 mg/m\^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m\^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
Part B: Pevonedistat + Docetaxel
n=2 Participants
Pevonedistat 25 mg/m\^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
4 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
1 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 168 hours post-dosePopulation: The PK evaluable population included all enrolled participants who received the protocol-specified single \[14C\]-pevonedistat dose in Part A and did not received any excluded medications throughout the completion of Part A and had sufficient concentration-time data.
Outcome measures
| Measure |
Part A: [14C]-Pevonedistat 25 mg/m^2
n=7 Participants
\[14C\]-pevonedistat (containing approximately 60-98 mCi \[approximately 2.22-3.626 MBq\] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A.
|
Part B: Pevonedistat + Paclitaxel and Carboplatin
Pevonedistat 20 mg/m\^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m\^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
Part B: Pevonedistat + Docetaxel
Pevonedistat 25 mg/m\^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|---|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Pevonedistat in Plasma
|
49.3 percentage distribution of TRA
Standard Deviation 9.8
|
—
|
—
|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Metabolite-1 in Plasma
|
14.6 percentage distribution of TRA
Standard Deviation 4.9
|
—
|
—
|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Metabolite-2 in Plasma
|
21.5 percentage distribution of TRA
Standard Deviation 3.0
|
—
|
—
|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Metabolite-3 in Plasma
|
4.5 percentage distribution of TRA
Standard Deviation 0.6
|
—
|
—
|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Metabolite-7 in Plasma
|
0.8 percentage distribution of TRA
Standard Deviation 0.3
|
—
|
—
|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Metabolite-10b in Plasma
|
6.5 percentage distribution of TRA
Standard Deviation 2.1
|
—
|
—
|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Metabolite-16 in Plasma
|
1.0 percentage distribution of TRA
Standard Deviation 0.4
|
—
|
—
|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Metabolite-22 in Plasma
|
1.9 percentage distribution of TRA
Standard Deviation 0.8
|
—
|
—
|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Pevonedistat in Urine
|
10.5 percentage distribution of TRA
Standard Deviation 6.1
|
—
|
—
|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Metabolite-1 in Urine
|
46.5 percentage distribution of TRA
Standard Deviation 4.4
|
—
|
—
|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Metabolite-2 in Urine
|
19.1 percentage distribution of TRA
Standard Deviation 2.1
|
—
|
—
|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Metabolite-3 in Urine
|
9.9 percentage distribution of TRA
Standard Deviation 0.9
|
—
|
—
|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Metabolite-7 in Urine
|
1.8 percentage distribution of TRA
Standard Deviation 0.7
|
—
|
—
|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Metabolite-10b in Urine
|
3.5 percentage distribution of TRA
Standard Deviation 1.0
|
—
|
—
|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Metabolite-16 in Urine
|
6.1 percentage distribution of TRA
Standard Deviation 2.5
|
—
|
—
|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Metabolite-22 in Urine
|
1.3 percentage distribution of TRA
Standard Deviation 0.5
|
—
|
—
|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Metabolite-23 in Urine
|
0.8 percentage distribution of TRA
Standard Deviation 0.2
|
—
|
—
|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Metabolite-24 in Urine
|
1.7 percentage distribution of TRA
Standard Deviation 0.7
|
—
|
—
|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Pevonedistat in Feces
|
30.3 percentage distribution of TRA
Standard Deviation 9.9
|
—
|
—
|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Metabolite-1 in Feces
|
14.1 percentage distribution of TRA
Standard Deviation 8.3
|
—
|
—
|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Metabolite-2 in Feces
|
34.0 percentage distribution of TRA
Standard Deviation 4.0
|
—
|
—
|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Metabolite-3 in Feces
|
20.3 percentage distribution of TRA
Standard Deviation 2.9
|
—
|
—
|
|
Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces
Metabolite-7 in Feces
|
1.3 percentage distribution of TRA
Standard Deviation 0.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Cycle 11 (Cycle length =21 days)Population: The response-evaluable population included all participants who received at least 1 dose of study drug in Part B, had measurable disease as entry criteria for Part B, and had at least 1 post-baseline disease assessment.
The best overall response was defined as the participants with best response among complete response (CR) or partial response (PR) or stable disease (SD), or progressive disease (PD). It was assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than (\<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters as the best overall response after randomization. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
Outcome measures
| Measure |
Part A: [14C]-Pevonedistat 25 mg/m^2
n=5 Participants
\[14C\]-pevonedistat (containing approximately 60-98 mCi \[approximately 2.22-3.626 MBq\] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A.
|
Part B: Pevonedistat + Paclitaxel and Carboplatin
n=2 Participants
Pevonedistat 20 mg/m\^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m\^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
Part B: Pevonedistat + Docetaxel
Pevonedistat 25 mg/m\^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|---|
|
Part B: Number of Participants With Best Overall Response as Per Investigator's Assessment
CR
|
0 Participants
|
0 Participants
|
—
|
|
Part B: Number of Participants With Best Overall Response as Per Investigator's Assessment
PR
|
0 Participants
|
0 Participants
|
—
|
|
Part B: Number of Participants With Best Overall Response as Per Investigator's Assessment
SD
|
2 Participants
|
0 Participants
|
—
|
|
Part B: Number of Participants With Best Overall Response as Per Investigator's Assessment
PD
|
3 Participants
|
2 Participants
|
—
|
Adverse Events
Part A: [14C]-Pevonedistat 25 mg/m^2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Part B: Pevonedistat + Paclitaxel and Carboplatin
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Part B: Pevonedistat + Docetaxel
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Part A: [14C]-Pevonedistat 25 mg/m^2
n=8 participants at risk
\[14C\]-pevonedistat (containing approximately 60-98 mCi \[approximately 2.22-3.626 MBq\] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A.
|
Part B: Pevonedistat + Paclitaxel and Carboplatin
n=5 participants at risk
Pevonedistat 20 mg/m\^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m\^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
Part B: Pevonedistat + Docetaxel
n=2 participants at risk
Pevonedistat 25 mg/m\^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SARCOMA
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
FIBROSARCOMA
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
20.0%
1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
20.0%
1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
Other adverse events
| Measure |
Part A: [14C]-Pevonedistat 25 mg/m^2
n=8 participants at risk
\[14C\]-pevonedistat (containing approximately 60-98 mCi \[approximately 2.22-3.626 MBq\] of radioactive tracer), infusion, intravenously, single dose on Day 1 of Week 1 in Part A.
|
Part B: Pevonedistat + Paclitaxel and Carboplatin
n=5 participants at risk
Pevonedistat 20 mg/m\^2, infusion, intravenously, single dose, on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with paclitaxel 175 mg/m\^2, infusion, intravenously along with carboplatin AUC5, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
Part B: Pevonedistat + Docetaxel
n=2 participants at risk
Pevonedistat 25 mg/m\^2, infusion, intravenously, single dose on Days 1, 3 and 5 of each 21-days treatment cycle (up to 11 cycles), in combination with docetaxel 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-days treatment cycle (up to 11 cycles). Pevonedistat was administered after the docetaxel chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
40.0%
2/5 • Number of events 6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
100.0%
2/2 • Number of events 6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
25.0%
2/8 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
20.0%
1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Renal and urinary disorders
Urinary Retention
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
40.0%
2/5 • Number of events 5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
40.0%
2/5 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
50.0%
1/2 • Number of events 3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
General disorders
Asthenia
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
40.0%
2/5 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
50.0%
1/2 • Number of events 4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
General disorders
Pain
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
40.0%
2/5 • Number of events 4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
50.0%
1/2 • Number of events 3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
General disorders
Chest Pain
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
20.0%
1/5 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
General disorders
Fatigue
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
40.0%
2/5 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
20.0%
1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
General disorders
Swelling
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
20.0%
1/5 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
General disorders
Chills
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
20.0%
1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
40.0%
2/5 • Number of events 7 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
40.0%
2/5 • Number of events 6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
20.0%
1/5 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
20.0%
1/5 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
20.0%
1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Investigations
Blood Urea Increased
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
20.0%
1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Investigations
Weight Decreased
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
40.0%
2/5 • Number of events 5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
40.0%
2/5 • Number of events 4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
20.0%
1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
20.0%
1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
20.0%
1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
20.0%
1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mueller's Mixed Tumour
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
20.0%
1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
20.0%
1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Eye disorders
Conjunctival Haemorrhage
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
50.0%
1/2 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
20.0%
1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
20.0%
1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
|
Vascular disorders
Peripheral Venous Disease
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
20.0%
1/5 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
0.00%
0/2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Reported AEs and deaths are TEAEs that occurred between the first dose of the study drug and 30 days after the last dose of the study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER