Trial Outcomes & Findings for Study of E7046 in Subjects With Selected Advanced Malignancies (NCT NCT02540291)
NCT ID: NCT02540291
Last Updated: 2020-02-17
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 2 years)
Results posted on
2020-02-17
Participant Flow
Participants took part in the study at 2 sites in the United States and 1 site in France from 30 July 2015 to 27 February 2018.
A total of 31 participants with advanced malignancies were enrolled, of which 30 participants received study treatment. The study was terminated before the start of the cohort expansion part. The discontinuation of participants from study is presented in the overall study table below.
Participant milestones
| Measure |
E7046 125 mg
Participants received E7046 125 milligram (mg) capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 250 mg
Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 500 mg
Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 750 mg
Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
7
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
7
|
7
|
Reasons for withdrawal
| Measure |
E7046 125 mg
Participants received E7046 125 milligram (mg) capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 250 mg
Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 500 mg
Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 750 mg
Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
|---|---|---|---|---|
|
Overall Study
Death
|
7
|
7
|
5
|
7
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal Of Consent
|
0
|
1
|
0
|
0
|
|
Overall Study
Study Terminated By Sponsor
|
1
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of E7046 in Subjects With Selected Advanced Malignancies
Baseline characteristics by cohort
| Measure |
E7046 125 mg
n=8 Participants
Participants received E7046 125 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 250 mg
n=8 Participants
Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 500 mg
n=7 Participants
Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 750 mg
n=7 Participants
Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 12.15 • n=5 Participants
|
53.0 years
STANDARD_DEVIATION 17.10 • n=7 Participants
|
54.4 years
STANDARD_DEVIATION 13.40 • n=5 Participants
|
64.4 years
STANDARD_DEVIATION 10.18 • n=4 Participants
|
55.5 years
STANDARD_DEVIATION 13.82 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 2 years)Population: The FAS included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
E7046 125 mg
n=8 Participants
Participants received E7046 125 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 250 mg
n=8 Participants
Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 500 mg
n=7 Participants
Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 750 mg
n=7 Participants
Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
8 Participants
|
7 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
5 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (21 days)Population: The dose limiting toxicity (DLT) evaluable set included all participants who were evaluable for the DLTs and had taken at least 1 dose of E7046.
Outcome measures
| Measure |
E7046 125 mg
n=30 Participants
Participants received E7046 125 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 250 mg
Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 500 mg
Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 750 mg
Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of E7046
|
NA mg
MTD could not be determined due to the absence of DLTs.
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 (21 days)Population: The DLT evaluable set included all participants who were evaluable for the DLTs and had taken at least 1 dose of E7046.
Two RP2Ds were planned to be evaluated.
Outcome measures
| Measure |
E7046 125 mg
n=30 Participants
Participants received E7046 125 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 250 mg
Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 500 mg
Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 750 mg
Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
|---|---|---|---|---|
|
Recommended Phase 2 Dose (RP2D) of E7046
RP2D 1
|
250 mg
|
—
|
—
|
—
|
|
Recommended Phase 2 Dose (RP2D) of E7046
RP2D 2
|
500 mg
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose date until disease progression/recurrence (approximately up to 2 years)Population: The FAS included all participants who received at least 1 dose of study drug.
The ORR is the percentage of participants achieving a best overall response of confirmed immune-related partial response (irPR) + immune-related complete response (irCR), according to immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) v1.1, from first dose date until disease progression/recurrence.
Outcome measures
| Measure |
E7046 125 mg
n=8 Participants
Participants received E7046 125 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 250 mg
n=8 Participants
Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 500 mg
n=7 Participants
Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 750 mg
n=7 Participants
Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: From first dose date to the date of the first documentation of confirmed disease progression or death (approximately up to 2 years)Population: The FAS included all participants who received at least 1 dose of study drug.
PFS is defined as the time from first dose date to the date of the first documentation of confirmed disease progression or death, whichever occurs first, according to irRECIST v1.1. PFS was calculated using Kaplan-Meier product-limit method and Greenwood Formula.
Outcome measures
| Measure |
E7046 125 mg
n=8 Participants
Participants received E7046 125 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 250 mg
n=8 Participants
Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 500 mg
n=7 Participants
Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 750 mg
n=7 Participants
Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
1.5 months
Interval 1.1 to 4.0
|
1.4 months
Interval 1.1 to 4.1
|
1.3 months
Interval 1.2 to 1.6
|
1.3 months
Interval 0.9 to
Upper limit of confidence interval could not be calculated because of high number of participants that were censored from the analysis.
|
SECONDARY outcome
Timeframe: From the date of first documented confirmed irCR/irPR until the first documentation of confirmed disease progression or death (approximately up to 2 years)Population: The FAS included all participants who received at least 1 dose of study drug. No participants had irCR or irPR; therefore, the DOR could not be determined.
The DOR is defined as the time from the date of first documented confirmed irCR/irPR, according to irRECIST v1.1 until the first documentation of confirmed disease progression or death, whichever came first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the first dose date until disease progression/recurrence (approximately up to 2 years)Population: The FAS included all participants who received at least 1 dose of study drug.
The DCR is percentage of participants achieving best overall response of confirmed irCR, irPR, or immune-related stable disease (irSD) (lasting at least 5 weeks), according to irRECIST v1.1 from the first dose date until disease progression/recurrence.
Outcome measures
| Measure |
E7046 125 mg
n=8 Participants
Participants received E7046 125 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 250 mg
n=8 Participants
Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 500 mg
n=7 Participants
Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 750 mg
n=7 Participants
Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
0 percentage of participants
Interval 0.0 to 0.0
|
42.9 percentage of participants
Interval 9.9 to 81.6
|
SECONDARY outcome
Timeframe: From first dose date until disease progression/recurrence (approximately up to 2 years)Population: The FAS included all participants who received at least 1 dose of study drug.
The CBR is the percentage of participants achieving irPR + irCR + irSD (lasting at least 24 weeks), according to irRECIST v1.1 from first dose date until disease progression/recurrence.
Outcome measures
| Measure |
E7046 125 mg
n=8 Participants
Participants received E7046 125 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 250 mg
n=8 Participants
Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 500 mg
n=7 Participants
Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 750 mg
n=7 Participants
Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
|---|---|---|---|---|
|
Clinical Benefit Rate (CBR)
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
Adverse Events
E7046 125 mg
Serious events: 5 serious events
Other events: 7 other events
Deaths: 7 deaths
E7046 250 mg
Serious events: 6 serious events
Other events: 7 other events
Deaths: 7 deaths
E7046 500 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 5 deaths
E7046 750 mg
Serious events: 3 serious events
Other events: 7 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
E7046 125 mg
n=8 participants at risk
Participants received E7046 125 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 250 mg
n=8 participants at risk
Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 500 mg
n=7 participants at risk
Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 750 mg
n=7 participants at risk
Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiopulmonary failure
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
25.0%
2/8 • Number of events 2 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
General disorders
Death
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
General disorders
Fatigue
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
General disorders
Pyrexia
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Infections and infestations
Pneumonia
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Investigations
Blood bilirubin increased
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
25.0%
2/8 • Number of events 2 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
Other adverse events
| Measure |
E7046 125 mg
n=8 participants at risk
Participants received E7046 125 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 250 mg
n=8 participants at risk
Participants received E7046 250 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 500 mg
n=7 participants at risk
Participants received E7046 500 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
E7046 750 mg
n=7 participants at risk
Participants received E7046 750 mg capsules, orally, once daily, in continuous 21-day treatment cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
2/8 • Number of events 2 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
42.9%
3/7 • Number of events 3 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
25.0%
2/8 • Number of events 3 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
25.0%
2/8 • Number of events 2 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 3 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
2/8 • Number of events 2 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
25.0%
2/8 • Number of events 2 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
42.9%
3/7 • Number of events 5 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
42.9%
3/7 • Number of events 4 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
37.5%
3/8 • Number of events 3 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
42.9%
3/7 • Number of events 5 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
42.9%
3/7 • Number of events 3 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
25.0%
2/8 • Number of events 2 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
28.6%
2/7 • Number of events 3 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
General disorders
Chills
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
37.5%
3/8 • Number of events 3 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
42.9%
3/7 • Number of events 6 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
42.9%
3/7 • Number of events 3 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
General disorders
Malaise
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
General disorders
Oedema peripheral
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
25.0%
2/8 • Number of events 2 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
General disorders
Pyrexia
|
25.0%
2/8 • Number of events 2 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Investigations
Blood creatinine increased
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 2 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Investigations
Weight decreased
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
25.0%
2/8 • Number of events 3 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
2/8 • Number of events 2 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
25.0%
2/8 • Number of events 2 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
28.6%
2/7 • Number of events 4 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 2 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
28.6%
2/7 • Number of events 2 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
2/8 • Number of events 3 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 2 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 2 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
28.6%
2/7 • Number of events 2 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
12.5%
1/8 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
37.5%
3/8 • Number of events 3 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
25.0%
2/8 • Number of events 2 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • Number of events 2 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
25.0%
2/8 • Number of events 2 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
14.3%
1/7 • Number of events 1 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
0.00%
0/7 • From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place