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Trial record 13 of 157 for:    eribulin

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 (BOLD 113)

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ClinicalTrials.gov Identifier: NCT02171260
Recruitment Status : Completed
First Posted : June 24, 2014
Results First Posted : December 24, 2018
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
Children's Oncology Group
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pediatrics
Solid Tumors
Intervention Drug: Eribulin Mesylate
Enrollment 23
Recruitment Details Participants took part in the study at 18 investigative sites in the United States from 31 July 2014 to 28 January 2016.
Pre-assignment Details 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.
Arm/Group Title Part A1: Eribulin Mesylate 1.1 mg/m^2 Part A1: Eribulin Mesylate 1.4 mg/m^2 Part A1: Eribulin Mesylate 1.8 mg/m^2 Part A1: Eribulin Mesylate PK Expansion
Hide Arm/Group Description 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). 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. 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. 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).
Period Title: Overall Study
Started 6 6 5 5
Completed 0 0 0 0
Not Completed 6 6 5 5
Reason Not Completed
Death             0             0             0             1
Physician Decision             1             0             1             0
Withdrawal by Subject             1             0             0             0
Evidence of progressive disease             4             6             4             4
Arm/Group Title Part A1: Eribulin Mesylate 1.1 mg/m^2 Part A1: Eribulin Mesylate 1.4 mg/m^2 Part A1: Eribulin Mesylate 1.8 mg/m^2 Part A1: Eribulin Mesylate PK Expansion Total
Hide Arm/Group Description 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 6 6 5 5 22
Hide Baseline Analysis Population Description
The safety analysis set (SAS) included all participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 5 participants 5 participants 22 participants
14.0  (3.52) 10.7  (2.25) 13.0  (3.24) 12.6  (5.50) 12.5  (3.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 5 participants 5 participants 22 participants
Female
1
  16.7%
4
  66.7%
3
  60.0%
2
  40.0%
10
  45.5%
Male
5
  83.3%
2
  33.3%
2
  40.0%
3
  60.0%
12
  54.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 5 participants 5 participants 22 participants
Hispanic or Latino
0
   0.0%
2
  33.3%
1
  20.0%
1
  20.0%
4
  18.2%
Not Hispanic or Latino
6
 100.0%
4
  66.7%
4
  80.0%
4
  80.0%
18
  81.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 5 participants 5 participants 22 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  16.7%
0
   0.0%
1
  20.0%
1
  20.0%
3
  13.6%
White
5
  83.3%
5
  83.3%
4
  80.0%
2
  40.0%
16
  72.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
  16.7%
0
   0.0%
2
  40.0%
3
  13.6%
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of Eribulin Mesylate
Hide Description 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.
Time Frame First dose of study drug (Baseline) up to Cycle 1 Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Part A1: All Participants
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: mg/m^2
1.4
2.Primary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
Hide Outcome Measure Data
Hide Analysis Population Description
The SAS included all participants who received at least one dose of study drug.
Arm/Group Title Part A1: Eribulin Mesylate 1.1 mg/m^2 Part A1: Eribulin Mesylate 1.4 mg/m^2 Part A1: Eribulin Mesylate 1.8 mg/m^2 Part A1: Eribulin Mesylate PK Expansion
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 6 5 5
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
6
 100.0%
6
 100.0%
5
 100.0%
5
 100.0%
SAEs
2
  33.3%
1
  16.7%
3
  60.0%
4
  80.0%
3.Primary Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values
Hide Description [Not Specified]
Time Frame First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
Hide Outcome Measure Data
Hide Analysis Population Description
The SAS included all participants who received at least one dose of study drug.
Arm/Group Title Part A1: Eribulin Mesylate 1.1 mg/m^2 Part A1: Eribulin Mesylate 1.4 mg/m^2 Part A1: Eribulin Mesylate 1.8 mg/m^2 Part A1: Eribulin Mesylate PK Expansion
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 6 5 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Number of Participants With Clinically Significant Vital Sign Values
Hide Description [Not Specified]
Time Frame First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
Hide Outcome Measure Data
Hide Analysis Population Description
The SAS included all participants who received at least one dose of study drug.
Arm/Group Title Part A1: Eribulin Mesylate 1.1 mg/m^2 Part A1: Eribulin Mesylate 1.4 mg/m^2 Part A1: Eribulin Mesylate 1.8 mg/m^2 Part A1: Eribulin Mesylate PK Expansion
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 6 5 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Primary Outcome
Title Number of Participants With Clinically Significant Electrocardiogram (EKG)
Hide Description [Not Specified]
Time Frame First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
Hide Outcome Measure Data
Hide Analysis Population Description
The SAS included all participants who received at least one dose of study drug.
Arm/Group Title Part A1: Eribulin Mesylate 1.1 mg/m^2 Part A1: Eribulin Mesylate 1.4 mg/m^2 Part A1: Eribulin Mesylate 1.8 mg/m^2 Part A1: Eribulin Mesylate PK Expansion
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 6 5 5
Measure Type: Count of Participants
Unit of Measure: Participants
>30 millisecond (msec)
1
  16.7%
1
  16.7%
1
  20.0%
0
   0.0%
>60 msec
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
6.Primary Outcome
Title T1/2: Terminal Half-life for Eribulin Mesylate
Hide Description [Not Specified]
Time Frame Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Part A1: Eribulin Mesylate 1.1 mg/m^2 Part A1: Eribulin Mesylate 1.4 mg/m^2 Part A1: Eribulin Mesylate 1.8 mg/m^2 Part A1: Eribulin Mesylate PK Expansion
Hide Arm/Group Description:
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 4 cycles, or until PD or unacceptable toxicity or DLT's.
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.
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.
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.
Overall Number of Participants Analyzed 3 6 5 4
Median (Full Range)
Unit of Measure: hours
37.00
(29.6 to 38.9)
38.60
(23.3 to 44.3)
44.00
(30.6 to 56.5)
33.25
(30.2 to 45.9)
7.Primary Outcome
Title Cmax: Maximum Observed Plasma Concentration for Eribulin Mesylate
Hide Description [Not Specified]
Time Frame Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PAS included all participants who had sufficient PK data to derive at least one PK parameter.
Arm/Group Title Part A1: Eribulin Mesylate 1.1 mg/m^2 Part A1: Eribulin Mesylate 1.4 mg/m^2 Part A1: Eribulin Mesylate 1.8 mg/m^2 Part A1: Eribulin Mesylate PK Expansion
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 6 5 5
Mean (Standard Deviation)
Unit of Measure: nanogram/milliliter (ng/mL)
353.8  (59.24) 472.3  (158.23) 382.6  (296.97) 382.8  (247.05)
8.Primary Outcome
Title Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Eribulin Mesylate
Hide Description [Not Specified]
Time Frame Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PAS included all participants who had sufficient PK data to derive at least one PK parameter.
Arm/Group Title Part A1: Eribulin Mesylate 1.1 mg/m2 Part A1: Eribulin Mesylate 1.4 mg/m2 Part A1: Eribulin Mesylate 1.8 mg/m2 Part A1: Eribulin Mesylate PK Expansion
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 6 5 5
Median (Full Range)
Unit of Measure: hours
0.170
(0.12 to 0.32)
0.170
(0.12 to 0.22)
0.370
(0.08 to 0.50)
0.300
(0.17 to 0.32)
9.Primary Outcome
Title AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for Eribulin Mesylate
Hide Description [Not Specified]
Time Frame Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PAS included all participants who had sufficient PK data to derive at least one PK parameter.
Arm/Group Title Part A1: Eribulin Mesylate 1.1 mg/m^2 Part A1: Eribulin Mesylate 1.4 mg/m^2 Part A1: Eribulin Mesylate 1.8 mg/m^2 Part A1: Eribulin Mesylate PK Expansion
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 6 5 5
Mean (Standard Deviation)
Unit of Measure: hour * nanogram per milliliter (h*ng/mL)
744.0  (353.03) 758.2  (303.38) 1363.0  (1378.53) 1010.8  (538.94)
10.Primary Outcome
Title AUC 0-inf: Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time for Eribulin Mesylate
Hide Description [Not Specified]
Time Frame Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Part A1: Eribulin Mesylate 1.1 mg/m^2 Part A1: Eribulin Mesylate 1.4 mg/m^2 Part A1: Eribulin Mesylate 1.8 mg/m^2 Part A1: Eribulin Mesylate PK Expansion
Hide Arm/Group Description:
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
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.
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.
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.
Overall Number of Participants Analyzed 3 6 5 4
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
654.3  (342.72) 830.5  (331.14) 1556.6  (1619.37) 907.8  (493.59)
11.Primary Outcome
Title CL: Clearance for Eribulin Mesylate
Hide Description [Not Specified]
Time Frame Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Part A1: Eribulin Mesylate 1.1 mg/m^2 Part A1: Eribulin Mesylate 1.4 mg/m^2 Part A1: Eribulin Mesylate 1.8 mg/m^2 Part A1: Eribulin Mesylate PK Expansion
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 3 6 5 4
Mean (Standard Deviation)
Unit of Measure: milliliter per hour (mL/h)
2226.7  (957.10) 1951.7  (469.27) 2483.8  (1190.94) 2348.8  (1437.56)
12.Primary Outcome
Title Vd: Volume of Distribution for Eribulin Mesylate
Hide Description [Not Specified]
Time Frame Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Part A1: Eribulin Mesylate 1.1 mg/m^2 Part A1: Eribulin Mesylate 1.4 mg/m^2 Part A1: Eribulin Mesylate 1.8 mg/m^2 Part A1: Eribulin Mesylate PK Expansion
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 3 6 5 4
Mean (Standard Deviation)
Unit of Measure: milliliter
75966.7  (34322.34) 66766.7  (32230.40) 89840.0  (43363.96) 77525.0  (39176.64)
13.Secondary Outcome
Title Number of Participants With Best Overall Response
Hide Description 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.
Time Frame First dose of study drug (Baseline) up to approximately Cycle 8 (21-days treatment cycle)
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Hide Analysis Population Description
The SAS included all participants who received at least one dose of study drug.
Arm/Group Title Part A1: Eribulin Mesylate 1.1 mg/m^2 Part A1: Eribulin Mesylate 1.4 mg/m^2 Part A1: Eribulin Mesylate 1.8 mg/m2 Part A1: Eribulin Mesylate PK Expansion
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 6 5 5
Measure Type: Count of Participants
Unit of Measure: Participants
Stable Disease
1
  16.7%
1
  16.7%
1
  20.0%
0
   0.0%
Partial Response
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part A1: Eribulin Mesylate 1.1 mg/m^2 Part A1: Eribulin Mesylate 1.4 mg/m^2 Part A1: Eribulin Mesylate 1.8 mg/m^2 Part A1: Eribulin Mesylate PK Expansion
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
Part A1: Eribulin Mesylate 1.1 mg/m^2 Part A1: Eribulin Mesylate 1.4 mg/m^2 Part A1: Eribulin Mesylate 1.8 mg/m^2 Part A1: Eribulin Mesylate PK Expansion
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%)   0/5 (0.00%)   1/5 (20.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Part A1: Eribulin Mesylate 1.1 mg/m^2 Part A1: Eribulin Mesylate 1.4 mg/m^2 Part A1: Eribulin Mesylate 1.8 mg/m^2 Part A1: Eribulin Mesylate PK Expansion
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/6 (33.33%)   1/6 (16.67%)   3/5 (60.00%)   4/5 (80.00%) 
Blood and lymphatic system disorders         
Febrile neutropenia  1  0/6 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/5 (0.00%) 
Neutropenia  1  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%) 
Gastrointestinal disorders         
Gingival pain  1  0/6 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  1/5 (20.00%) 
General disorders         
Fatigue  1  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%) 
Pyrexia  1  0/6 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/5 (0.00%) 
Infections and infestations         
Device related infection  1  0/6 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  1/5 (20.00%) 
Lung infection  1  0/6 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  1/5 (20.00%) 
Pneumonia  1  0/6 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  1/5 (20.00%) 
Metabolism and nutrition disorders         
Dehydration  1  0/6 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/5 (0.00%) 
Musculoskeletal and connective tissue disorders         
Joint swelling  1  1/6 (16.67%)  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%) 
Pain in extremity  1  1/6 (16.67%)  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Tumour pain  1  0/6 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/5 (0.00%) 
Nervous system disorders         
Hypoaesthesia  1  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%) 
Paraesthesia  1  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  1/6 (16.67%)  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%) 
Hypoxia  1  1/6 (16.67%)  0/6 (0.00%)  0/5 (0.00%)  2/5 (40.00%) 
Laryngeal haemorrhage  1  0/6 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  1/5 (20.00%) 
Pleural effusion  1  1/6 (16.67%)  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%) 
Tachypnoea  1  0/6 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  1/5 (20.00%) 
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part A1: Eribulin Mesylate 1.1 mg/m^2 Part A1: Eribulin Mesylate 1.4 mg/m^2 Part A1: Eribulin Mesylate 1.8 mg/m^2 Part A1: Eribulin Mesylate PK Expansion
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   6/6 (100.00%)   5/5 (100.00%)   5/5 (100.00%) 
Blood and lymphatic system disorders         
Anaemia  1  4/6 (66.67%)  4/6 (66.67%)  2/5 (40.00%)  3/5 (60.00%) 
Lymphopenia  1  1/6 (16.67%)  2/6 (33.33%)  1/5 (20.00%)  1/5 (20.00%) 
Neutropenia  1  0/6 (0.00%)  2/6 (33.33%)  1/5 (20.00%)  1/5 (20.00%) 
Cardiac disorders         
Palpitations  1  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  1/5 (20.00%) 
Tachycardia  1  1/6 (16.67%)  0/6 (0.00%)  1/5 (20.00%)  1/5 (20.00%) 
Ear and labyrinth disorders         
Ear pain  1  1/6 (16.67%)  0/6 (0.00%)  1/5 (20.00%)  0/5 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  1  2/6 (33.33%)  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%) 
Constipation  1  2/6 (33.33%)  2/6 (33.33%)  3/5 (60.00%)  0/5 (0.00%) 
Diarrhoea  1  0/6 (0.00%)  2/6 (33.33%)  1/5 (20.00%)  1/5 (20.00%) 
Dyspepsia  1  1/6 (16.67%)  0/6 (0.00%)  0/5 (0.00%)  1/5 (20.00%) 
Nausea  1  3/6 (50.00%)  3/6 (50.00%)  4/5 (80.00%)  1/5 (20.00%) 
Vomiting  1  3/6 (50.00%)  2/6 (33.33%)  2/5 (40.00%)  2/5 (40.00%) 
General disorders         
Fatigue  1  2/6 (33.33%)  1/6 (16.67%)  2/5 (40.00%)  2/5 (40.00%) 
Malaise  1  0/6 (0.00%)  1/6 (16.67%)  1/5 (20.00%)  0/5 (0.00%) 
Non-cardiac chest pain  1  2/6 (33.33%)  4/6 (66.67%)  1/5 (20.00%)  0/5 (0.00%) 
Pyrexia  1  0/6 (0.00%)  2/6 (33.33%)  2/5 (40.00%)  2/5 (40.00%) 
Injury, poisoning and procedural complications         
Contusion  1  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  1/5 (20.00%) 
Investigations         
Alanine aminotransferase increased  1  3/6 (50.00%)  2/6 (33.33%)  2/5 (40.00%)  1/5 (20.00%) 
Aspartate aminotransferase increased  1  4/6 (66.67%)  2/6 (33.33%)  2/5 (40.00%)  1/5 (20.00%) 
Blood albumin decreased  1  2/6 (33.33%)  1/6 (16.67%)  0/5 (0.00%)  1/5 (20.00%) 
Blood bilirubin increased  1  1/6 (16.67%)  0/6 (0.00%)  1/5 (20.00%)  1/5 (20.00%) 
Blood calcium decreased  1  1/6 (16.67%)  0/6 (0.00%)  1/5 (20.00%)  1/5 (20.00%) 
Blood chloride decreased  1  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  1/5 (20.00%) 
Blood creatinine increased  1  1/6 (16.67%)  1/6 (16.67%)  0/5 (0.00%)  1/5 (20.00%) 
Blood glucose decreased  1  1/6 (16.67%)  0/6 (0.00%)  1/5 (20.00%)  0/5 (0.00%) 
Blood phosphorus decreased  1  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  1/5 (20.00%) 
Blood potassium decreased  1  0/6 (0.00%)  1/6 (16.67%)  2/5 (40.00%)  1/5 (20.00%) 
Blood sodium decreased  1  3/6 (50.00%)  2/6 (33.33%)  0/5 (0.00%)  1/5 (20.00%) 
Blood urine present  1  0/6 (0.00%)  1/6 (16.67%)  1/5 (20.00%)  1/5 (20.00%) 
Electrocardiogram QT prolonged  1  0/6 (0.00%)  2/6 (33.33%)  1/5 (20.00%)  2/5 (40.00%) 
Haemoglobin decreased  1  3/6 (50.00%)  3/6 (50.00%)  4/5 (80.00%)  0/5 (0.00%) 
Lymphocyte count decreased  1  4/6 (66.67%)  3/6 (50.00%)  3/5 (60.00%)  4/5 (80.00%) 
Neutrophil count decreased  1  5/6 (83.33%)  2/6 (33.33%)  4/5 (80.00%)  2/5 (40.00%) 
Platelet count decreased  1  1/6 (16.67%)  2/6 (33.33%)  4/5 (80.00%)  2/5 (40.00%) 
Protein urine present  1  1/6 (16.67%)  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%) 
Weight decreased  1  1/6 (16.67%)  1/6 (16.67%)  2/5 (40.00%)  0/5 (0.00%) 
White blood cell count decreased  1  5/6 (83.33%)  5/6 (83.33%)  5/5 (100.00%)  4/5 (80.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1  3/6 (50.00%)  4/6 (66.67%)  2/5 (40.00%)  2/5 (40.00%) 
Hyperglycaemia  1  1/6 (16.67%)  2/6 (33.33%)  1/5 (20.00%)  1/5 (20.00%) 
Hypermagnesaemia  1  0/6 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  1/5 (20.00%) 
Hypoalbuminaemia  1  1/6 (16.67%)  3/6 (50.00%)  0/5 (0.00%)  2/5 (40.00%) 
Hypocalcaemia  1  1/6 (16.67%)  2/6 (33.33%)  1/5 (20.00%)  1/5 (20.00%) 
Hypoglycaemia  1  1/6 (16.67%)  0/6 (0.00%)  0/5 (0.00%)  1/5 (20.00%) 
Hypokalaemia  1  1/6 (16.67%)  1/6 (16.67%)  0/5 (0.00%)  2/5 (40.00%) 
Hyponatraemia  1  1/6 (16.67%)  0/6 (0.00%)  1/5 (20.00%)  1/5 (20.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  1/6 (16.67%)  0/6 (0.00%)  2/5 (40.00%)  1/5 (20.00%) 
Back pain  1  1/6 (16.67%)  1/6 (16.67%)  2/5 (40.00%)  0/5 (0.00%) 
Bone pain  1  1/6 (16.67%)  0/6 (0.00%)  1/5 (20.00%)  0/5 (0.00%) 
Musculoskeletal pain  1  2/6 (33.33%)  2/6 (33.33%)  0/5 (0.00%)  1/5 (20.00%) 
Neck pain  1  2/6 (33.33%)  0/6 (0.00%)  0/5 (0.00%)  1/5 (20.00%) 
Pain in extremity  1  3/6 (50.00%)  0/6 (0.00%)  0/5 (0.00%)  2/5 (40.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Tumour pain  1  0/6 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  1/5 (20.00%) 
Nervous system disorders         
Dizziness  1  0/6 (0.00%)  2/6 (33.33%)  0/5 (0.00%)  0/5 (0.00%) 
Headache  1  2/6 (33.33%)  3/6 (50.00%)  3/5 (60.00%)  1/5 (20.00%) 
Hypoaesthesia  1  1/6 (16.67%)  0/6 (0.00%)  0/5 (0.00%)  2/5 (40.00%) 
Paraesthesia  1  0/6 (0.00%)  1/6 (16.67%)  1/5 (20.00%)  0/5 (0.00%) 
Psychiatric disorders         
Anxiety  1  0/6 (0.00%)  2/6 (33.33%)  0/5 (0.00%)  0/5 (0.00%) 
Renal and urinary disorders         
Proteinuria  1  0/6 (0.00%)  1/6 (16.67%)  2/5 (40.00%)  2/5 (40.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  0/6 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  2/5 (40.00%) 
Dyspnoea  1  0/6 (0.00%)  2/6 (33.33%)  0/5 (0.00%)  1/5 (20.00%) 
Oropharyngeal pain  1  1/6 (16.67%)  3/6 (50.00%)  1/5 (20.00%)  1/5 (20.00%) 
Rhinorrhoea  1  0/6 (0.00%)  1/6 (16.67%)  1/5 (20.00%)  1/5 (20.00%) 
Skin and subcutaneous tissue disorders         
Alopecia  1  1/6 (16.67%)  2/6 (33.33%)  3/5 (60.00%)  0/5 (0.00%) 
Dry skin  1  2/6 (33.33%)  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%) 
Pruritus  1  2/6 (33.33%)  0/6 (0.00%)  1/5 (20.00%)  1/5 (20.00%) 
Vascular disorders         
Hypertension  1  1/6 (16.67%)  1/6 (16.67%)  1/5 (20.00%)  1/5 (20.00%) 
Hypotension  1  1/6 (16.67%)  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%) 
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Eisai Medical Services
Organization: Eisai, Inc.
Phone: 1-888-422-4743
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT02171260     History of Changes
Other Study ID Numbers: E7389-A001-113 (ADVL1314)
First Submitted: June 18, 2014
First Posted: June 24, 2014
Results First Submitted: June 18, 2018
Results First Posted: December 24, 2018
Last Update Posted: January 15, 2019