Trial Outcomes & Findings for A Study to Assess the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics (PK) of TAK-931 in Participants With Advanced Solid Tumors (NCT NCT03708211)
NCT ID: NCT03708211
Last Updated: 2020-12-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Cycle 0 Days 1 and 3 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle 0 length is equal to [=] 16 days)
Results posted on
2020-12-29
Participant Flow
Participants took part in the study at investigative sites in the Netherlands from 28 March 2019 to 03 December 2019.
Participants with advanced solid tumors were enrolled in 2-part cross-over design study to receive 1 of 2 treatment sequences in Part 1: TAK-931 80 mg PIC + TAK-931 80 mg tablet (Sequence A) or TAK-931 80 mg tablet + TAK-931 80 mg PIC (Sequence B). Part 2 of the study was not conducted due to the business decision, which was unrelated to safety.
Participant milestones
| Measure |
Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet
TAK-931 80 milligram (mg), powder in capsule (PIC), orally, once on Day 1, followed by TAK-931 80 mg tablet, orally, once on Day 3, further followed by TAK-931 50 mg PIC, orally, once daily from Days 5 to 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles, until progressive disease (PD), or unacceptable toxicity or any treatment discontinuation is determined.
|
Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC
TAK-931 80 mg, tablet, orally, once on Day 1, followed by TAK-931 80 mg PIC, orally, once on Day 3, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
8
|
Reasons for withdrawal
| Measure |
Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet
TAK-931 80 milligram (mg), powder in capsule (PIC), orally, once on Day 1, followed by TAK-931 80 mg tablet, orally, once on Day 3, further followed by TAK-931 50 mg PIC, orally, once daily from Days 5 to 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles, until progressive disease (PD), or unacceptable toxicity or any treatment discontinuation is determined.
|
Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC
TAK-931 80 mg, tablet, orally, once on Day 1, followed by TAK-931 80 mg PIC, orally, once on Day 3, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
|---|---|---|
|
Overall Study
Progressive Disease
|
10
|
7
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Other
|
2
|
0
|
Baseline Characteristics
A Study to Assess the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics (PK) of TAK-931 in Participants With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet
n=12 Participants
TAK-931 80 mg, PIC, orally, once on Day 1, followed by TAK-931 80 mg tablet, orally, once on Day 3, further followed by TAK-931 50 mg PIC, orally, once daily from Days 5 to 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles, until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC
n=8 Participants
TAK-931 80 mg, tablet, orally, once on Day 1, followed by TAK-931 80 mg PIC, orally, once on Day 3, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 9.36 • n=5 Participants
|
57.6 years
STANDARD_DEVIATION 12.69 • n=7 Participants
|
60.6 years
STANDARD_DEVIATION 10.78 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
26.56 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.165 • n=5 Participants
|
26.50 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 5.292 • n=7 Participants
|
26.53 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.610 • n=5 Participants
|
PRIMARY outcome
Timeframe: Cycle 0 Days 1 and 3 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle 0 length is equal to [=] 16 days)Population: The pharmacokinetic (PK) set included all participants who completed the protocol-specified dosing and had sufficient plasma TAK-931 concentration-time data to reliably estimate the PK parameter.
Outcome measures
| Measure |
TAK-931 80 mg PIC
n=20 Participants
TAK-931 80 mg, PIC, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
TAK-931 80 mg Tablet
n=20 Participants
TAK-931 80 mg, tablet, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
|---|---|---|
|
Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-931 Tablets in Reference to PIC
|
251.45 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 41.91
|
270.09 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 36.44
|
PRIMARY outcome
Timeframe: Cycle 0 Days 1 and 3 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle 0 length = 16 days)Population: The PK set included all participants who completed the protocol-specified dosing and had sufficient plasma TAK-931 concentration-time data to reliably estimate the PK parameter.
Outcome measures
| Measure |
TAK-931 80 mg PIC
n=20 Participants
TAK-931 80 mg, PIC, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
TAK-931 80 mg Tablet
n=20 Participants
TAK-931 80 mg, tablet, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
|---|---|---|
|
Part 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-931 Tablets in Reference to PIC
|
1869.0329 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 44.7484
|
1898.9016 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 45.2980
|
PRIMARY outcome
Timeframe: Cycle 0 Days 1 and 3 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle 0 length = 16 days)Population: The PK set included all participants who completed the protocol-specified dosing and had sufficient plasma TAK-931 concentration-time data to reliably estimate the PK parameter.
Outcome measures
| Measure |
TAK-931 80 mg PIC
n=20 Participants
TAK-931 80 mg, PIC, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
TAK-931 80 mg Tablet
n=20 Participants
TAK-931 80 mg, tablet, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
|---|---|---|
|
Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-931 Tablets in Reference to PIC
|
1901.1447 h*ng/mL
Geometric Coefficient of Variation 44.6999
|
1925.8648 h*ng/mL
Geometric Coefficient of Variation 45.2966
|
SECONDARY outcome
Timeframe: Cycle 0 Days 1 and 3 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle 0 length = 16 days)Population: The PK set included all participants who completed the protocol-specified dosing and had sufficient plasma TAK-931 concentration-time data to reliably estimate the PK parameter.
Outcome measures
| Measure |
TAK-931 80 mg PIC
n=20 Participants
TAK-931 80 mg, PIC, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
TAK-931 80 mg Tablet
n=20 Participants
TAK-931 80 mg, tablet, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
|---|---|---|
|
Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-931 as PIC and Tablets
|
1.6830 hour
Interval 0.917 to 4.117
|
1.9830 hour
Interval 0.483 to 4.033
|
SECONDARY outcome
Timeframe: Cycle 0 Days 1 and 3 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle 0 length = 16 days)Population: The PK set included all participants who completed the protocol-specified dosing and had sufficient plasma TAK-931 concentration-time data to reliably estimate the PK parameter.
Outcome measures
| Measure |
TAK-931 80 mg PIC
n=20 Participants
TAK-931 80 mg, PIC, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
TAK-931 80 mg Tablet
n=20 Participants
TAK-931 80 mg, tablet, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
|---|---|---|
|
Part 1, CL/F: Oral Clearance for TAK-931
|
42.0799 liter per hour (L/h)
Geometric Coefficient of Variation 44.6999
|
41.5397 liter per hour (L/h)
Geometric Coefficient of Variation 45.2966
|
SECONDARY outcome
Timeframe: Cycle 0 Days 1 and 3 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle 0 length = 16 days)Population: The PK set included all participants who completed the protocol-specified dosing and had sufficient plasma TAK-931 concentration-time data to reliably estimate the PK parameter.
Outcome measures
| Measure |
TAK-931 80 mg PIC
n=20 Participants
TAK-931 80 mg, PIC, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
TAK-931 80 mg Tablet
n=20 Participants
TAK-931 80 mg, tablet, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
|---|---|---|
|
Part 1, T1/2z: Terminal Disposition Phase Half-life for TAK-931
|
7.3250 hour
Geometric Coefficient of Variation 25.4121
|
7.3683 hour
Geometric Coefficient of Variation 18.6369
|
SECONDARY outcome
Timeframe: Baseline up to 8 monthsPopulation: The response-evaluable population included participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 postbaseline response. As planned, efficacy data was collected and analyzed as per sequence and in accordance with the study design.
ORR was defined as the percentage of participants achieving complete response (CR) and partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), CR was defined as disappearance of all lesions, PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
TAK-931 80 mg PIC
n=11 Participants
TAK-931 80 mg, PIC, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
TAK-931 80 mg Tablet
n=8 Participants
TAK-931 80 mg, tablet, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
|---|---|---|
|
Part 1: Overall Response Rate (ORR)
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of first documentation of PD or death due to any cause, whichever occurred first (up to 8 months)Population: The safety set included all participants who received any amount of study drug. As planned, efficacy data was collected and analyzed as per sequence and in accordance with the study design.
PFS was defined as the time from the date of randomization to the date of first documentation of PD or death due to any cause, whichever occured first. Per RECIST V1.1, PD was defined as at least a 20% increase in the SoD (Sum of Diameters) of target lesions, taking as a reference the smallest (nadir) SoD since (and including) baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 millimeter (mm).
Outcome measures
| Measure |
TAK-931 80 mg PIC
n=12 Participants
TAK-931 80 mg, PIC, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
TAK-931 80 mg Tablet
n=8 Participants
TAK-931 80 mg, tablet, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
|---|---|---|
|
Part 1: Progression-free Survival (PFS)
|
1.9 months
Interval 1.7 to 2.8
|
2.0 months
Interval 1.4 to 3.6
|
SECONDARY outcome
Timeframe: Baseline up to 8 monthsPopulation: The response-evaluable population included participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 postbaseline response. As planned, efficacy data was collected and analyzed as per sequence and in accordance with the study design.
DCR was defined as the percentage of participants with CR, PR plus stable disease (SD) greater than or equal to (\>=) 1 post baseline computed tomography (CT) scan evaluation from treatment initiation to qualify for DCR. Per RECIST v 1.1, CR was defined as disappearance of all lesions. PR was defined as at least a 30% decrease in the sum of the LD of lesions, taking as reference the baseline sum LD. PD was defined as at least a 20% increase in the SoD of target lesions, taking as a reference the smallest (nadir) SoD since (and including) baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
TAK-931 80 mg PIC
n=11 Participants
TAK-931 80 mg, PIC, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
TAK-931 80 mg Tablet
n=8 Participants
TAK-931 80 mg, tablet, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
|---|---|---|
|
Part 1: Disease Control Rate (DCR)
|
18.2 percentage of participants
|
25.0 percentage of participants
|
SECONDARY outcome
Timeframe: From the date of first documentation of a response to the date of first documentation of PD ( up to 8 months)Population: The response-evaluable population included participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 postbaseline response. Here overall number of participants "N" are those who had CR or PR. As planned, efficacy data was collected and analyzed as per sequence and in accordance with the study design.
DOR was defined as the time from the date of first documentation of a response to the date of first documentation of PD. Per RECIST v1.1, CR was defined as disappearance of all lesions, PR was defined as at least a 30% decrease in the sum of the LD of lesions, taking as reference the baseline sum LD. PD was defined as at least a 20% increase in the SoD of target lesions, taking as a reference the smallest (nadir) SoD since (and including) baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the start of the study drug up to Day 30 after the last dose of study drug (up to 8 months)Population: The safety set included all participants who received any amount of study drug. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
Outcome measures
| Measure |
TAK-931 80 mg PIC
n=12 Participants
TAK-931 80 mg, PIC, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
TAK-931 80 mg Tablet
n=8 Participants
TAK-931 80 mg, tablet, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
|---|---|---|
|
Part 1: Percentage of Participants With Serious Adverse Events (SAEs), Treatment-emergent Adverse Events (TEAEs), and TEAEs Leading to Discontinuation or Dose Modification
SAEs
|
16.7 percentage of participants
|
25.0 percentage of participants
|
|
Part 1: Percentage of Participants With Serious Adverse Events (SAEs), Treatment-emergent Adverse Events (TEAEs), and TEAEs Leading to Discontinuation or Dose Modification
TEAEs
|
91.7 percentage of participants
|
100 percentage of participants
|
|
Part 1: Percentage of Participants With Serious Adverse Events (SAEs), Treatment-emergent Adverse Events (TEAEs), and TEAEs Leading to Discontinuation or Dose Modification
TEAEs Leading to Discontinuation or Dose Modification
|
8.3 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From the start of the study drug up to Day 30 after the last dose of study drug (up to 8 months)Population: The safety set included all participants who received any amount of study drug. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) was defined as an adverse event with an onset that occurs after receiving study drug. A severity grade was defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. As per NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.
Outcome measures
| Measure |
TAK-931 80 mg PIC
n=12 Participants
TAK-931 80 mg, PIC, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
TAK-931 80 mg Tablet
n=8 Participants
TAK-931 80 mg, tablet, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
|---|---|---|
|
Part 1: Percentage of Participants With Grade 3 or Higher TEAEs
|
41.7 percentage of participants
|
37.5 percentage of participants
|
SECONDARY outcome
Timeframe: From the start of the study drug up to Day 30 after the last dose of study drug (up to 8 months)Population: The safety set included all participants who received any amount of study drug. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
Outcome measures
| Measure |
TAK-931 80 mg PIC
n=12 Participants
TAK-931 80 mg, PIC, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
TAK-931 80 mg Tablet
n=8 Participants
TAK-931 80 mg, tablet, orally, once, on Day 1 or Day 3 of Cycle 0, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
|---|---|---|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Eosinophils: Grade 0 to Grade 0
|
83.3 percentage of participants
|
87.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Eosinophils: Grade 0 to Grade 1
|
8.3 percentage of participants
|
0.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Eosinophils: Grade 1 to Grade 0
|
8.3 percentage of participants
|
12.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Hemoglobin: Grade 0 to Grade 0
|
33.3 percentage of participants
|
0.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Hemoglobin: Grade 0 to Grade 1
|
8.3 percentage of participants
|
12.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Hemoglobin: Grade 1 to Grade 0
|
8.3 percentage of participants
|
0.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Hemoglobin: Grade 1 to Grade 1
|
41.7 percentage of participants
|
50.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Hemoglobin: Grade 1 to Grade 2
|
8.3 percentage of participants
|
12.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Hemoglobin: Grade 1 to Grade 3
|
0.0 percentage of participants
|
12.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Hemoglobin: Grade 2 to Grade 2
|
0.0 percentage of participants
|
12.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Leukocytes: Grade 0 to Grade 0
|
41.7 percentage of participants
|
75.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Leukocytes: Grade 0 to Grade 1
|
41.7 percentage of participants
|
12.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Leukocytes: Grade 0 to Grade 2
|
16.7 percentage of participants
|
0.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Leukocytes: Grade 0 to Grade 3
|
0.0 percentage of participants
|
12.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Lymphocytes: Grade 0 to Grade 0
|
33.3 percentage of participants
|
50.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Lymphocytes: Grade 0 to Grade 1
|
16.7 percentage of participants
|
12.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Lymphocytes: Grade 0 to Grade 2
|
16.7 percentage of participants
|
12.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Lymphocytes: Grade 0 to Grade 3
|
8.3 percentage of participants
|
0.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Lymphocytes: Grade 1 to Grade 1
|
8.3 percentage of participants
|
0.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Lymphocytes: Grade 1 to Grade 2
|
16.7 percentage of participants
|
0.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Lymphocytes: Grade 2 to Grade 2
|
0.0 percentage of participants
|
12.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Lymphocytes: Grade 3 to Grade 2
|
0.0 percentage of participants
|
12.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Neutrophils: Grade 0 to Grade 0
|
83.3 percentage of participants
|
75.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Neutrophils: Grade 0 to Grade 2
|
8.3 percentage of participants
|
12.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Neutrophils: Grade 0 to Grade 3
|
8.3 percentage of participants
|
0.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Neutrophils: Grade 0 to Grade 4
|
0.0 percentage of participants
|
12.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Platelets: Grade 0 to Grade 0
|
100.0 percentage of participants
|
62.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Platelets: Grade 0 to Grade 1
|
0.0 percentage of participants
|
25.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Platelets: Grade 1 to Grade 1
|
0.0 percentage of participants
|
12.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Alanine Aminotransferase: Grade 0 to Grade 0
|
91.7 percentage of participants
|
62.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Alanine Aminotransferase: Grade 0 to Grade 1
|
0.0 percentage of participants
|
25.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Alanine Aminotransferase: Grade 1 to Grade 0
|
8.3 percentage of participants
|
0.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Alanine Aminotransferase: Grade 1 to Grade 1
|
0.0 percentage of participants
|
12.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Alkaline Phosphatase: Grade 0 to Grade 0
|
33.3 percentage of participants
|
0.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Alkaline Phosphatase: Grade 0 to Grade 1
|
16.7 percentage of participants
|
37.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Alkaline Phosphatase: Grade 1 to Grade 0
|
33.3 percentage of participants
|
25.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Alkaline Phosphatase: Grade 2 to Grade 0
|
8.3 percentage of participants
|
37.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Alkaline Phosphatase: Grade 3 to Grade 0
|
8.3 percentage of participants
|
0.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Aspartate Aminotransferase: Grade 0 to Grade 0
|
58.3 percentage of participants
|
50.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Aspartate Aminotransferase: Grade 0 to Grade 1
|
25.0 percentage of participants
|
0.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Aspartate Aminotransferase: Grade 1 to Grade 0
|
8.3 percentage of participants
|
12.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Aspartate Aminotransferase: Grade 1 to Grade 1
|
8.3 percentage of participants
|
25.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Aspartate Aminotransferase: Grade 2 to Grade 0
|
0.0 percentage of participants
|
12.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Bilirubin: Grade 0 to Grade 0
|
83.3 percentage of participants
|
87.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Bilirubin: Grade 0 to Grade 1
|
16.7 percentage of participants
|
12.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Creatinine: Grade 0 to Grade 0
|
66.7 percentage of participants
|
75.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Creatinine: Grade 0 to Grade 1
|
16.7 percentage of participants
|
0.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Creatinine: Grade 0 to Grade 2
|
8.3 percentage of participants
|
0.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Creatinine: Grade 1 to Grade 1
|
8.3 percentage of participants
|
25.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Glucose: Grade 0 to Grade 0
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Magnesium: Grade 0 to Grade 0
|
50.0 percentage of participants
|
50.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Magnesium: Grade 0 to Grade 1
|
8.3 percentage of participants
|
25.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Magnesium: Grade 1 to Grade 1
|
41.7 percentage of participants
|
25.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Potassium: Grade 0 to Grade 0
|
83.3 percentage of participants
|
62.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Potassium: Grade 0 to Grade 1
|
8.3 percentage of participants
|
12.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Potassium: Grade 0 to Grade 3
|
0.0 percentage of participants
|
12.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Potassium: Grade 1 to Grade 1
|
8.3 percentage of participants
|
12.5 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Sodium: Grade 0 to Grade 0
|
50.0 percentage of participants
|
75.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Sodium: Grade 0 to Grade 1
|
41.7 percentage of participants
|
25.0 percentage of participants
|
|
Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters
Sodium: Grade 1 to Grade 0
|
8.3 percentage of participants
|
0.0 percentage of participants
|
Adverse Events
Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet
n=12 participants at risk
TAK-931 80 mg, PIC, orally, once on Day 1, followed by TAK-931 80 mg tablet, orally, once on Day 3, further followed by TAK-931 50 mg PIC, orally, once daily from Days 5 to 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles, until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC
n=8 participants at risk
TAK-931 80 mg, tablet, orally, once on Day 1, followed by TAK-931 80 mg PIC, orally, once on Day 3, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
|---|---|---|
|
Gastrointestinal disorders
Ileus
|
16.7%
2/12 • Number of events 3 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
0.00%
0/8 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/12 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
12.5%
1/8 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/12 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
12.5%
1/8 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Infections and infestations
Cholecystitis infective
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
0.00%
0/8 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
Other adverse events
| Measure |
Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet
n=12 participants at risk
TAK-931 80 mg, PIC, orally, once on Day 1, followed by TAK-931 80 mg tablet, orally, once on Day 3, further followed by TAK-931 50 mg PIC, orally, once daily from Days 5 to 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles, until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC
n=8 participants at risk
TAK-931 80 mg, tablet, orally, once on Day 1, followed by TAK-931 80 mg PIC, orally, once on Day 3, further followed by TAK-931 50 mg PIC, orally, once daily from Day 5 to Day 16 in Cycle 0 (16-day treatment cycle), followed by a 7-day rest period, further followed by TAK-931 50 mg PIC, orally, once daily for up to 14 days in Cycle 1, followed by a 7-day rest period in 21-day treatment cycles until PD, or unacceptable toxicity or any treatment discontinuation is determined.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
25.0%
3/12 • Number of events 3 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
50.0%
4/8 • Number of events 6 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • Number of events 2 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
50.0%
4/8 • Number of events 4 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
2/12 • Number of events 5 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
37.5%
3/8 • Number of events 3 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
12.5%
1/8 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
12.5%
1/8 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
12.5%
1/8 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • Number of events 2 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
0.00%
0/8 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
0.00%
0/8 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
General disorders
Fatigue
|
50.0%
6/12 • Number of events 8 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
75.0%
6/8 • Number of events 10 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
General disorders
Oedema peripheral
|
0.00%
0/12 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
12.5%
1/8 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
4/12 • Number of events 7 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
25.0%
2/8 • Number of events 2 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
0.00%
0/8 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/12 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
12.5%
1/8 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
0.00%
0/8 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
12.5%
1/8 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
0.00%
0/8 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Investigations
Weight decreased
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
25.0%
2/8 • Number of events 2 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
12.5%
1/8 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Investigations
Blood creatinine increased
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
0.00%
0/8 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/12 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
12.5%
1/8 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Investigations
Platelet count decreased
|
0.00%
0/12 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
12.5%
1/8 • Number of events 2 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/12 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
37.5%
3/8 • Number of events 3 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/12 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
12.5%
1/8 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
0.00%
0/8 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/12 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
12.5%
1/8 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Infections and infestations
Otitis media
|
8.3%
1/12 • Number of events 2 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
0.00%
0/8 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Infections and infestations
Pneumonia
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
0.00%
0/8 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Infections and infestations
Rash pustular
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
0.00%
0/8 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
12.5%
1/8 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
12.5%
1/8 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
12.5%
1/8 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Nervous system disorders
Aphasia
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
0.00%
0/8 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Nervous system disorders
Disturbance in attention
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
0.00%
0/8 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
0.00%
0/8 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Nervous system disorders
Facial nerve disorder
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
0.00%
0/8 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/12 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
12.5%
1/8 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
12.5%
1/8 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
0.00%
0/8 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
0.00%
0/8 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/12 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
12.5%
1/8 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
12.5%
1/8 • Number of events 2 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/12 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
12.5%
1/8 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
0.00%
0/8 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Eye disorders
Dry eye
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
12.5%
1/8 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Hepatobiliary disorders
Hepatic pain
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
0.00%
0/8 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Injury, poisoning and procedural complications
Limb injury
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
0.00%
0/8 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/12 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
12.5%
1/8 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
|
Vascular disorders
Hypertension
|
8.3%
1/12 • Number of events 1 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
0.00%
0/8 • TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months)
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. As planned, safety data was collected and analyzed as per sequence and in accordance with the study design.
|
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