Trial Outcomes & Findings for Relative Bioavailability of Pimasertib in Cancer Patients (NCT NCT01992874)
NCT ID: NCT01992874
Last Updated: 2017-08-15
Results Overview
Maximum observed plasma concentration (Cmax) was calculated for Part A Pimasertib 60 mg Capsule and tablet.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
38 participants
Primary outcome timeframe
Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
Results posted on
2017-08-15
Participant Flow
First/last subject (informed consent): Nov 2013/Feb 2015. Clinical data cut-off: May 2014, Study completion date: Feb 2015
A total of 45 subjects were screened. 38 subjects were enrolled and received the trial medication completed two sequence cross-over Part A and further continued in open label Part B.
Participant milestones
| Measure |
Part A: Pimasertib Capsule Then Pimasertib Tablet
A single dose of 2 Pimasertib 30 mg capsule administered orally on Day 1 in first intervention period followed by a single dose of 3 Pimasertib 20 mg tablet single dose administered orally on Day 3, of Part A of the study. A washout period of 48 hours was maintained between the administration of the two treatments.
|
Part A: Pimasertib Tablet Then Pimasertib Capsule
A single dose of 3 Pimasertib 20 mg tablet administered orally on Day 1 in first intervention period followed by a single dose of 2 Pimasertib 30 mg capsule single dose administered orally on Day 3, of Part A of the study. A washout period of 48 hours was maintained between the administration of the two treatments.
|
Part B:Pimasertib Capsule
Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
|
|---|---|---|---|
|
Part A
STARTED
|
21
|
17
|
0
|
|
Part A
COMPLETED
|
21
|
17
|
0
|
|
Part A
NOT COMPLETED
|
0
|
0
|
0
|
|
Part B
STARTED
|
0
|
0
|
38
|
|
Part B
COMPLETED
|
0
|
0
|
38
|
|
Part B
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Relative Bioavailability of Pimasertib in Cancer Patients
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=38 Participants
It included all the subjects randomized to receive either Pimasertib 60 mg capsule and Pimasertib 60 mg tablet first in Part A and Pimasertib 60 mg capsule in Part B of the study.
|
|---|---|
|
Age, Continuous
|
60.6 years
STANDARD_DEVIATION 11.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3Population: Pharmacokinetic (PK) analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability.
Maximum observed plasma concentration (Cmax) was calculated for Part A Pimasertib 60 mg Capsule and tablet.
Outcome measures
| Measure |
Part A: Pimasertib 60 mg Capsule
n=37 Participants
A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
|
Part A: Pimasertib 60 mg Tablet
n=37 Participants
A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
|
Part B: Pimasertib Capsule
Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
254.6 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 75.7
|
314.1 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 84.2
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3Population: PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability.
Area under the plasma concentration-time curve from time zero to the last sampling time (AUC0-t) at which the concentration was at or above the lower limit of quantification.
Outcome measures
| Measure |
Part A: Pimasertib 60 mg Capsule
n=37 Participants
A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
|
Part A: Pimasertib 60 mg Tablet
n=37 Participants
A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
|
Part B: Pimasertib Capsule
Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Zero to the Last Quantifiable Concentration (AUC 0-t)
|
979.0 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 76.5
|
1060.7 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 73.0
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3Population: PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analysed) signifies the number of subjects analysed for this outcome measure.
Outcome measures
| Measure |
Part A: Pimasertib 60 mg Capsule
n=32 Participants
A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
|
Part A: Pimasertib 60 mg Tablet
n=36 Participants
A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
|
Part B: Pimasertib Capsule
Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC0-inf)
|
1110.3 h*ng/mL
Geometric Coefficient of Variation 74.2
|
1109.2 h*ng/mL
Geometric Coefficient of Variation 72.9
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3Population: PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability.
Outcome measures
| Measure |
Part A: Pimasertib 60 mg Capsule
n=37 Participants
A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
|
Part A: Pimasertib 60 mg Tablet
n=37 Participants
A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
|
Part B: Pimasertib Capsule
Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
|
|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
0.750 hour
Interval 0.25 to 4.05
|
0.517 hour
Interval 0.25 to 3.93
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3Population: PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analyzed) signifies the number of subjects analysed for this outcome measure.
Outcome measures
| Measure |
Part A: Pimasertib 60 mg Capsule
n=32 Participants
A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
|
Part A: Pimasertib 60 mg Tablet
n=36 Participants
A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
|
Part B: Pimasertib Capsule
Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
|
|---|---|---|---|
|
Apparent Terminal Half-life (t1/2)
|
4.38 hour
Interval 1.65 to 8.15
|
4.47 hour
Interval 0.71 to 6.21
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3Population: PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analyzed) signifies the number of subjects analysed for this outcome measure.
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
| Measure |
Part A: Pimasertib 60 mg Capsule
n=32 Participants
A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
|
Part A: Pimasertib 60 mg Tablet
n=36 Participants
A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
|
Part B: Pimasertib Capsule
Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
|
|---|---|---|---|
|
Apparent Total Body Clearance (CL/f)
|
54.041 liter per hour (L/h)
Geometric Coefficient of Variation 74.2
|
54.092 liter per hour (L/h)
Geometric Coefficient of Variation 72.9
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3Population: PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analyzed) signifies the number of subjects analysed for this outcome measure.
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Outcome measures
| Measure |
Part A: Pimasertib 60 mg Capsule
n=32 Participants
A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
|
Part A: Pimasertib 60 mg Tablet
n=36 Participants
A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
|
Part B: Pimasertib Capsule
Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
|
|---|---|---|---|
|
Apparent Volume of Distribution (Vz/f)
|
346.454 Liter
Geometric Coefficient of Variation 54.1
|
334.540 Liter
Geometric Coefficient of Variation 59.0
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3Population: PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analyzed) signifies the number of subjects analysed for this outcome measure.
Outcome measures
| Measure |
Part A: Pimasertib 60 mg Capsule
n=32 Participants
A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
|
Part A: Pimasertib 60 mg Tablet
n=36 Participants
A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
|
Part B: Pimasertib Capsule
Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
|
|---|---|---|---|
|
Terminal Rate Constant (λz)
|
0.16 1/h
Interval 0.09 to 0.42
|
0.15 1/h
Interval 0.11 to 0.98
|
—
|
SECONDARY outcome
Timeframe: From the first dose of study drug administration until 30 days after the last dose of study drug administration, assessed up to 14 MonthsPopulation: Safety analysis set included all subjects who received at least one dose of IMP.
An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug administration until 30 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pre treatment state.
Outcome measures
| Measure |
Part A: Pimasertib 60 mg Capsule
n=38 Participants
A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
|
Part A: Pimasertib 60 mg Tablet
n=37 Participants
A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
|
Part B: Pimasertib Capsule
n=38 Participants
Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
|
|---|---|---|---|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation
TEAEs
|
19 subjects
|
20 subjects
|
38 subjects
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation
Serious TEAEs
|
1 subjects
|
0 subjects
|
19 subjects
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation
TEAEs leading to discontinuation
|
0 subjects
|
0 subjects
|
13 subjects
|
SECONDARY outcome
Timeframe: Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 MonthsPopulation: Safety analysis set included all subjects who received at least one dose of IMP.
CR as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 defined as disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to less than (\<)10 millimeter (mm).
Outcome measures
| Measure |
Part A: Pimasertib 60 mg Capsule
n=38 Participants
A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
|
Part A: Pimasertib 60 mg Tablet
A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
|
Part B: Pimasertib Capsule
Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
|
|---|---|---|---|
|
Part B: Number of Subjects Who Experienced Complete Response (CR)
|
0 subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 MonthsPopulation: Safety analysis set included all subjects who received at least one dose of IMP.
PR as per RECIST v1.1 defined as 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Part A: Pimasertib 60 mg Capsule
n=38 Participants
A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
|
Part A: Pimasertib 60 mg Tablet
A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
|
Part B: Pimasertib Capsule
Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
|
|---|---|---|---|
|
Part B: Number of Subjects Who Experienced Partial Response (PR)
|
1 subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 MonthsPopulation: Safety analysis set included all subjects who received at least one dose of IMP.
SD as per RECIST v1.1 defined as neither shrinkage to qualify for PR nor increase to qualify for progressive disease (PD) taking the smallest sum diameters on study as reference. PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; PD = 20% increase in sum of diameters of target lesions; the appearance of \>=1 new lesions.
Outcome measures
| Measure |
Part A: Pimasertib 60 mg Capsule
n=38 Participants
A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
|
Part A: Pimasertib 60 mg Tablet
A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
|
Part B: Pimasertib Capsule
Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
|
|---|---|---|---|
|
Part B: Number of Subjects Who Experienced Stable Disease (SD)
|
10 subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 MonthsPopulation: Safety analysis set included all subjects who received at least one dose of IMP.
PD as per RECIST v1.1 defined as 20% increase in sum of diameters of target lesions; the appearance of \>=1 new lesions.
Outcome measures
| Measure |
Part A: Pimasertib 60 mg Capsule
n=38 Participants
A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
|
Part A: Pimasertib 60 mg Tablet
A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
|
Part B: Pimasertib Capsule
Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
|
|---|---|---|---|
|
Part B: Number of Subjects Who Experienced Progressive Disease (PD)
|
15 subjects
|
—
|
—
|
Adverse Events
Part A: Pimasertib 60 mg Capsule
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Part A: Pimasertib 60 mg Tablet
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Part B: Pimasertib Capsule (BID)
Serious events: 19 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: Pimasertib 60 mg Capsule
n=38 participants at risk
A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
|
Part A: Pimasertib 60 mg Tablet
n=37 participants at risk
A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
|
Part B: Pimasertib Capsule (BID)
n=38 participants at risk
Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
General disorders
Pyrexia
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
General disorders
Disease progression
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
General disorders
Fatigue
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Gastrointestinal disorders
Non-cardiac chest pain
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
General disorders
Oedema peripheral
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Infections and infestations
Pneumonia klebsiella
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Infections and infestations
Septic shock
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Nervous system disorders
Seizure
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Nervous system disorders
Syncope
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Vascular disorders
Hypertension
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Vascular disorders
Hypotension
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
Other adverse events
| Measure |
Part A: Pimasertib 60 mg Capsule
n=38 participants at risk
A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
|
Part A: Pimasertib 60 mg Tablet
n=37 participants at risk
A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
|
Part B: Pimasertib Capsule (BID)
n=38 participants at risk
Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
10.5%
4/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Blood and lymphatic system disorders
Anaemia
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
7.9%
3/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
7.9%
3/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Eye disorders
Vision blurred
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
10.8%
4/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
18.4%
7/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Eye disorders
Retinal detachment
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
23.7%
9/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Eye disorders
Visual impairment
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.7%
1/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
7.9%
3/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
10.5%
4/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Eye disorders
Macular detachment
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
10.5%
4/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Eye disorders
Dry eye
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
7.9%
3/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Eye disorders
Colour blindness acquired
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Eye disorders
Retinal exudates
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
16.2%
6/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
57.9%
22/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Gastrointestinal disorders
Nausea
|
7.9%
3/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.4%
2/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
34.2%
13/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
23.7%
9/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Gastrointestinal disorders
Stomatitis
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
18.4%
7/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.7%
1/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Gastrointestinal disorders
Dry mouth
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
General disorders
Fatigue
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
52.6%
20/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
General disorders
Oedema peripheral
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
26.3%
10/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
General disorders
Pyrexia
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
21.1%
8/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
General disorders
Chills
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
7.9%
3/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
7.9%
3/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
General disorders
Early satiety
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
7.9%
3/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Infections and infestations
Rash pustular
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
44.7%
17/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Investigations
Blood creatinine increased
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Investigations
Transaminases increased
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
10.5%
4/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.7%
1/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
10.5%
4/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.7%
1/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
18.4%
7/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Nervous system disorders
Headache
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
7.9%
3/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
7.9%
3/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Nervous system disorders
Syncope
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
7.9%
3/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.7%
1/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
15.8%
6/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
10.5%
4/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
10.5%
4/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.6%
1/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
2.7%
1/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
34.2%
13/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
15.8%
6/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
13.2%
5/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
7.9%
3/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Vascular disorders
Hypotension
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
7.9%
3/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
|
Vascular disorders
Hypertension
|
0.00%
0/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
0.00%
0/37 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
5.3%
2/38 • Baseline up to end of trial (before the start of a new anticancer therapy or 30 ± 2 days after the last investigational medicinal product administration.)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER