Trial Outcomes & Findings for This is a Phase 1 Study of Eribulin Mesylate in Pediatric Participants With Recurrent or Refractory Solid Tumors (Excluding [Central Nervous System] CNS), Including Lymphomas (NCT NCT02171260)
NCT ID: NCT02171260
Last Updated: 2019-01-15
Results Overview
MTD: maximum dose at which \<one third participants had DLT in Cycle 1. DLT: Grade 3/4 drug-related non hematological toxicity (except Grade 3 nausea, vomiting of \<3 days, Grade 3 liver enzyme elevation with alanine transaminase/aspartate transaminase and gamma glutamyl transferase that returned to Grade \<=1 or baseline prior to next dose; Grade 3 fever, infection, hypophosphatemia, hypokalemia, hypocalcemia/hypomagnesemia responsive to oral supplementation). Non-hematological toxicity causing \>=14 days delay between treatment cycles. Haematological DLTs included: Grade 4 neutropenia/platelets\<75,000/mm\^3 on Day 8 that does not resolve to absolute neutrophil count \>=750/mm\^3 and platelets\>=75,000/mm\^3 by Day 11, neutropenia for \>7 days; platelet count \<25,000/mm\^3, or required platelet transfusion, on 2 separate days within 7-day period;Grade 3 thrombocytopenia complicated by bleeding and/or required platelet transfusion;myelosuppression causing \>14 days delay between treatment cycles.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
First dose of study drug (Baseline) up to Cycle 1 Day 21
Results posted on
2019-01-15
Participant Flow
Participants took part in the study at 18 investigative sites in the United States from 31 July 2014 to 28 January 2016.
In Part A1, a total of 23 participants of greater than or equal to (\>=) 12 months were enrolled, of which 22 were treated in the study. In Part A2, the study was open for the enrolment of infant participants of less than 12 months of age, however no participants were enrolled into this part.
Participant milestones
| Measure |
Part A1: Eribulin Mesylate 1.1 mg/m^2
Participants received eribulin mesylate (E7389) 1.1 milligram per square meter (mg/m\^2), intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 4 cycles, or until progressive disease (PD) or unacceptable toxicity or drug related dose-limiting toxicities (DLT's).
|
Part A1: Eribulin Mesylate 1.4 mg/m^2
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.8 mg/m^2
Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate PK Expansion
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of pharmacokinetics (PK).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
5
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
5
|
5
|
Reasons for withdrawal
| Measure |
Part A1: Eribulin Mesylate 1.1 mg/m^2
Participants received eribulin mesylate (E7389) 1.1 milligram per square meter (mg/m\^2), intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 4 cycles, or until progressive disease (PD) or unacceptable toxicity or drug related dose-limiting toxicities (DLT's).
|
Part A1: Eribulin Mesylate 1.4 mg/m^2
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.8 mg/m^2
Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate PK Expansion
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of pharmacokinetics (PK).
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Overall Study
Evidence of progressive disease
|
4
|
6
|
4
|
4
|
Baseline Characteristics
This is a Phase 1 Study of Eribulin Mesylate in Pediatric Participants With Recurrent or Refractory Solid Tumors (Excluding [Central Nervous System] CNS), Including Lymphomas
Baseline characteristics by cohort
| Measure |
Part A1: Eribulin Mesylate 1.1 mg/m^2
n=6 Participants
Participants received eribulin mesylate 1.1 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 4 cycles, or until PD or unacceptable toxicity or DLT's.
|
Part A1: Eribulin Mesylate 1.4 mg/m^2
n=6 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.8 mg/m^2
n=5 Participants
Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate PK Expansion
n=5 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
14.0 years
STANDARD_DEVIATION 3.52 • n=5 Participants
|
10.7 years
STANDARD_DEVIATION 2.25 • n=7 Participants
|
13.0 years
STANDARD_DEVIATION 3.24 • n=5 Participants
|
12.6 years
STANDARD_DEVIATION 5.50 • n=4 Participants
|
12.5 years
STANDARD_DEVIATION 3.69 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
18 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
|
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)
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
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
16 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
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: First dose of study drug (Baseline) up to Cycle 1 Day 21Population: The dose evaluable set (DES) included all participants who were judged as DLT evaluable as recorded in the database. In order to be DLT evaluable, all participants had to complete Cycle 1.
MTD: maximum dose at which \<one third participants had DLT in Cycle 1. DLT: Grade 3/4 drug-related non hematological toxicity (except Grade 3 nausea, vomiting of \<3 days, Grade 3 liver enzyme elevation with alanine transaminase/aspartate transaminase and gamma glutamyl transferase that returned to Grade \<=1 or baseline prior to next dose; Grade 3 fever, infection, hypophosphatemia, hypokalemia, hypocalcemia/hypomagnesemia responsive to oral supplementation). Non-hematological toxicity causing \>=14 days delay between treatment cycles. Haematological DLTs included: Grade 4 neutropenia/platelets\<75,000/mm\^3 on Day 8 that does not resolve to absolute neutrophil count \>=750/mm\^3 and platelets\>=75,000/mm\^3 by Day 11, neutropenia for \>7 days; platelet count \<25,000/mm\^3, or required platelet transfusion, on 2 separate days within 7-day period;Grade 3 thrombocytopenia complicated by bleeding and/or required platelet transfusion;myelosuppression causing \>14 days delay between treatment cycles.
Outcome measures
| Measure |
Part A1: All Participants
n=20 Participants
All participants received eribulin mesylate 1.1 mg/m\^2 or 1.4 mg/m\^2 or 1.8 mg/m\^2 or 1.4 mg/m\^2 in PK expansion, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to a maximum of 8 cycles or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.4 mg/m^2
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.8 mg/m^2
Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate PK Expansion
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Eribulin Mesylate
|
1.4 mg/m^2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)Population: The SAS included all participants who received at least one dose of study drug.
TEAEs were defined as those adverse events (AEs) that occurred (or worsened, if present at Baseline) after the first dose of study drug through 30 days after the last dose of study drug. An AE was defined as any untoward medical occurrence in a participants or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. A SAE was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect.
Outcome measures
| Measure |
Part A1: All Participants
n=6 Participants
All participants received eribulin mesylate 1.1 mg/m\^2 or 1.4 mg/m\^2 or 1.8 mg/m\^2 or 1.4 mg/m\^2 in PK expansion, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to a maximum of 8 cycles or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.4 mg/m^2
n=6 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.8 mg/m^2
n=5 Participants
Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate PK Expansion
n=5 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
6 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
2 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)Population: The SAS included all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Part A1: All Participants
n=6 Participants
All participants received eribulin mesylate 1.1 mg/m\^2 or 1.4 mg/m\^2 or 1.8 mg/m\^2 or 1.4 mg/m\^2 in PK expansion, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to a maximum of 8 cycles or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.4 mg/m^2
n=6 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.8 mg/m^2
n=5 Participants
Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate PK Expansion
n=5 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)Population: The SAS included all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Part A1: All Participants
n=6 Participants
All participants received eribulin mesylate 1.1 mg/m\^2 or 1.4 mg/m\^2 or 1.8 mg/m\^2 or 1.4 mg/m\^2 in PK expansion, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to a maximum of 8 cycles or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.4 mg/m^2
n=6 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.8 mg/m^2
n=5 Participants
Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate PK Expansion
n=5 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Vital Sign Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)Population: The SAS included all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Part A1: All Participants
n=6 Participants
All participants received eribulin mesylate 1.1 mg/m\^2 or 1.4 mg/m\^2 or 1.8 mg/m\^2 or 1.4 mg/m\^2 in PK expansion, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to a maximum of 8 cycles or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.4 mg/m^2
n=6 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.8 mg/m^2
n=5 Participants
Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate PK Expansion
n=5 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Electrocardiogram (EKG)
>30 millisecond (msec)
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Electrocardiogram (EKG)
>60 msec
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dosePopulation: The pharmacokinetic analysis set (PAS) included all participants who had sufficient PK data to derive at least one PK parameter. The PAS where data at specified timepoints was available.
Outcome measures
| Measure |
Part A1: All Participants
n=3 Participants
All participants received eribulin mesylate 1.1 mg/m\^2 or 1.4 mg/m\^2 or 1.8 mg/m\^2 or 1.4 mg/m\^2 in PK expansion, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to a maximum of 8 cycles or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.4 mg/m^2
n=6 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.8 mg/m^2
n=5 Participants
Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate PK Expansion
n=4 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
|
|---|---|---|---|---|
|
T1/2: Terminal Half-life for Eribulin Mesylate
|
37.00 hours
Interval 29.6 to 38.9
|
38.60 hours
Interval 23.3 to 44.3
|
44.00 hours
Interval 30.6 to 56.5
|
33.25 hours
Interval 30.2 to 45.9
|
PRIMARY outcome
Timeframe: Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dosePopulation: The PAS included all participants who had sufficient PK data to derive at least one PK parameter.
Outcome measures
| Measure |
Part A1: All Participants
n=6 Participants
All participants received eribulin mesylate 1.1 mg/m\^2 or 1.4 mg/m\^2 or 1.8 mg/m\^2 or 1.4 mg/m\^2 in PK expansion, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to a maximum of 8 cycles or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.4 mg/m^2
n=6 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.8 mg/m^2
n=5 Participants
Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate PK Expansion
n=5 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
|
|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for Eribulin Mesylate
|
353.8 nanogram/milliliter (ng/mL)
Standard Deviation 59.24
|
472.3 nanogram/milliliter (ng/mL)
Standard Deviation 158.23
|
382.6 nanogram/milliliter (ng/mL)
Standard Deviation 296.97
|
382.8 nanogram/milliliter (ng/mL)
Standard Deviation 247.05
|
PRIMARY outcome
Timeframe: Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dosePopulation: The PAS included all participants who had sufficient PK data to derive at least one PK parameter.
Outcome measures
| Measure |
Part A1: All Participants
n=6 Participants
All participants received eribulin mesylate 1.1 mg/m\^2 or 1.4 mg/m\^2 or 1.8 mg/m\^2 or 1.4 mg/m\^2 in PK expansion, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to a maximum of 8 cycles or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.4 mg/m^2
n=6 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.8 mg/m^2
n=5 Participants
Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate PK Expansion
n=5 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
|
|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Eribulin Mesylate
|
0.170 hours
Interval 0.12 to 0.32
|
0.170 hours
Interval 0.12 to 0.22
|
0.370 hours
Interval 0.08 to 0.5
|
0.300 hours
Interval 0.17 to 0.32
|
PRIMARY outcome
Timeframe: Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dosePopulation: The PAS included all participants who had sufficient PK data to derive at least one PK parameter.
Outcome measures
| Measure |
Part A1: All Participants
n=6 Participants
All participants received eribulin mesylate 1.1 mg/m\^2 or 1.4 mg/m\^2 or 1.8 mg/m\^2 or 1.4 mg/m\^2 in PK expansion, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to a maximum of 8 cycles or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.4 mg/m^2
n=6 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.8 mg/m^2
n=5 Participants
Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate PK Expansion
n=5 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
|
|---|---|---|---|---|
|
AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for Eribulin Mesylate
|
744.0 hour * nanogram per milliliter (h*ng/mL)
Standard Deviation 353.03
|
758.2 hour * nanogram per milliliter (h*ng/mL)
Standard Deviation 303.38
|
1363.0 hour * nanogram per milliliter (h*ng/mL)
Standard Deviation 1378.53
|
1010.8 hour * nanogram per milliliter (h*ng/mL)
Standard Deviation 538.94
|
PRIMARY outcome
Timeframe: Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dosePopulation: The PAS included all participants who had sufficient PK data to derive at least one PK parameter. The PAS where data at specified timepoints was available.
Outcome measures
| Measure |
Part A1: All Participants
n=3 Participants
All participants received eribulin mesylate 1.1 mg/m\^2 or 1.4 mg/m\^2 or 1.8 mg/m\^2 or 1.4 mg/m\^2 in PK expansion, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to a maximum of 8 cycles or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.4 mg/m^2
n=6 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.8 mg/m^2
n=5 Participants
Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate PK Expansion
n=4 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
|
|---|---|---|---|---|
|
AUC 0-inf: Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time for Eribulin Mesylate
|
654.3 h*ng/mL
Standard Deviation 342.72
|
830.5 h*ng/mL
Standard Deviation 331.14
|
1556.6 h*ng/mL
Standard Deviation 1619.37
|
907.8 h*ng/mL
Standard Deviation 493.59
|
PRIMARY outcome
Timeframe: Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dosePopulation: The PAS included all participants who had sufficient PK data to derive at least one PK parameter. The PAS where data at specified timepoints was available.
Outcome measures
| Measure |
Part A1: All Participants
n=3 Participants
All participants received eribulin mesylate 1.1 mg/m\^2 or 1.4 mg/m\^2 or 1.8 mg/m\^2 or 1.4 mg/m\^2 in PK expansion, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to a maximum of 8 cycles or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.4 mg/m^2
n=6 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.8 mg/m^2
n=5 Participants
Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate PK Expansion
n=4 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
|
|---|---|---|---|---|
|
CL: Clearance for Eribulin Mesylate
|
2226.7 milliliter per hour (mL/h)
Standard Deviation 957.10
|
1951.7 milliliter per hour (mL/h)
Standard Deviation 469.27
|
2483.8 milliliter per hour (mL/h)
Standard Deviation 1190.94
|
2348.8 milliliter per hour (mL/h)
Standard Deviation 1437.56
|
PRIMARY outcome
Timeframe: Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dosePopulation: The PAS included all participants who had sufficient PK data to derive at least one PK parameter. The PAS where data at pacified timepoints was available.
Outcome measures
| Measure |
Part A1: All Participants
n=3 Participants
All participants received eribulin mesylate 1.1 mg/m\^2 or 1.4 mg/m\^2 or 1.8 mg/m\^2 or 1.4 mg/m\^2 in PK expansion, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to a maximum of 8 cycles or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.4 mg/m^2
n=6 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.8 mg/m^2
n=5 Participants
Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate PK Expansion
n=4 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
|
|---|---|---|---|---|
|
Vd: Volume of Distribution for Eribulin Mesylate
|
75966.7 milliliter
Standard Deviation 34322.34
|
66766.7 milliliter
Standard Deviation 32230.40
|
89840.0 milliliter
Standard Deviation 43363.96
|
77525.0 milliliter
Standard Deviation 39176.64
|
SECONDARY outcome
Timeframe: First dose of study drug (Baseline) up to approximately Cycle 8 (21-days treatment cycle)Population: The SAS included all participants who received at least one dose of study drug.
Best Overall Response (BOR): best response recorded from start of study treatment until disease progression (PD) or recurrence based on response evaluation criteria in solid tumors (RECIST) version 1.1 for target and non-target lesions. Participants with evaluable disease were also eligible for assessment.
Outcome measures
| Measure |
Part A1: All Participants
n=6 Participants
All participants received eribulin mesylate 1.1 mg/m\^2 or 1.4 mg/m\^2 or 1.8 mg/m\^2 or 1.4 mg/m\^2 in PK expansion, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to a maximum of 8 cycles or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.4 mg/m^2
n=6 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.8 mg/m^2
n=5 Participants
Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate PK Expansion
n=5 Participants
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
|
|---|---|---|---|---|
|
Number of Participants With Best Overall Response
Stable Disease
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Best Overall Response
Partial Response
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Part A1: Eribulin Mesylate 1.1 mg/m^2
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A1: Eribulin Mesylate 1.4 mg/m^2
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A1: Eribulin Mesylate 1.8 mg/m^2
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A1: Eribulin Mesylate PK Expansion
Serious events: 4 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Part A1: Eribulin Mesylate 1.1 mg/m^2
n=6 participants at risk
Participants received eribulin mesylate 1.1 milligram mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 4 cycles, or until PD or unacceptable toxicity or DLT's.
|
Part A1: Eribulin Mesylate 1.4 mg/m^2
n=6 participants at risk
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.8 mg/m^2
n=5 participants at risk
Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate PK Expansion
n=5 participants at risk
Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
General disorders
Fatigue
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
General disorders
Pyrexia
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Infections and infestations
Device related infection
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
Other adverse events
| Measure |
Part A1: Eribulin Mesylate 1.1 mg/m^2
n=6 participants at risk
Participants received eribulin mesylate 1.1 milligram mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 4 cycles, or until PD or unacceptable toxicity or DLT's.
|
Part A1: Eribulin Mesylate 1.4 mg/m^2
n=6 participants at risk
Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate 1.8 mg/m^2
n=5 participants at risk
Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.
|
Part A1: Eribulin Mesylate PK Expansion
n=5 participants at risk
Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of PK.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
4/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
66.7%
4/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
60.0%
3/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Cardiac disorders
Tachycardia
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Ear and labyrinth disorders
Ear pain
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
60.0%
3/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
50.0%
3/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
80.0%
4/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
3/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
General disorders
Fatigue
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
General disorders
Malaise
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
General disorders
Non-cardiac chest pain
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
66.7%
4/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
General disorders
Pyrexia
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
3/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
4/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Investigations
Blood albumin decreased
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Investigations
Blood calcium decreased
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Investigations
Blood chloride decreased
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Investigations
Blood glucose decreased
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Investigations
Blood potassium decreased
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Investigations
Blood sodium decreased
|
50.0%
3/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Investigations
Blood urine present
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Investigations
Haemoglobin decreased
|
50.0%
3/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
50.0%
3/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
80.0%
4/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Investigations
Lymphocyte count decreased
|
66.7%
4/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
50.0%
3/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
60.0%
3/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
80.0%
4/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Investigations
Neutrophil count decreased
|
83.3%
5/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
80.0%
4/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
80.0%
4/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Investigations
Protein urine present
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Investigations
Weight decreased
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Investigations
White blood cell count decreased
|
83.3%
5/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
83.3%
5/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
100.0%
5/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
80.0%
4/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
3/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
66.7%
4/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
50.0%
3/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
50.0%
3/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
50.0%
3/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
60.0%
3/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Nervous system disorders
Hypoaesthesia
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
40.0%
2/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
50.0%
3/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
60.0%
3/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
2/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
20.0%
1/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
16.7%
1/6 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
0.00%
0/5 • First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place