CompletedPhase 1

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

United States23 participantsStarted 2014-07-31

Plain-language summary

This is a Phase 1 study of eribulin mesylate in pediatric participants with recurrent or refractory solid tumors (excluding CNS), including lymphomas. Eribulin mesylate will be administered intravenously, once per day on Days 1 and 8 of a 21-day cycle. This study aims to determine the maximum tolerated dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of this regimen in Part A1 (participants greater than or equal to \[\>=\] 12 months and less than \[\<\] 18 years). Part A2 will enroll infants (greater than \[\>\] 6 months and \<12 months) one dose level behind the dose level at which participants in Part A1 are enrolling, in order to maximize safety for infant participants. Additionally, this study aims to describe the toxicities and the pharmacokinetics of eribulin mesylate when administered to children. In a preliminary manner, the antitumor effect of eribulin mesylate will also be described.

Who can participate

Age range6 Months – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea).
✓. Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (example Neulasta) or 7 days for short-acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair.
✓. Biologic (anti-neoplastic agent): At least 14 days after the last dose of a biologic agent. For agents that have known adverse events occurring beyond 14 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair.
✓. Immunotherapy: At least 42 days after the completion of any type of immunotherapy, example tumor vaccines.
✓. Monoclonal antibodies: At least 3 half-lives of the antibody after the last dose of a monoclonal antibody.
✓. X-ray telescope (XRT): At least 14 days after local palliative XRT (small port); At least 150 days must have elapsed if prior total body irradiation(TBI), craniospinal and/or entire spinal XRT or if \>=50% radiation of pelvis; At least 42 days must have elapsed if other substantial bone marrow (BM) radiation.

What they're measuring

Maximum Tolerated Dose (MTD) of Eribulin Mesylate

Timeframe: First dose of study drug (Baseline) up to Cycle 1 Day 21

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Timeframe: First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)

Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values

Timeframe: First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)

Number of Participants With Clinically Significant Vital Sign Values

Timeframe: First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)

Number of Participants With Clinically Significant Electrocardiogram (EKG)

Timeframe: First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)

T1/2: Terminal Half-life for Eribulin Mesylate

Timeframe: Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose

Cmax: Maximum Observed Plasma Concentration for Eribulin Mesylate

Trial details

NCT IDNCT02171260

SponsorEisai Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-01-28

Results submitted2018-06-18

View on ClinicalTrials.gov More Pediatrics trials

Plain-language summary

Who can participate

Age range6 Months – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea).
✓. Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (example Neulasta) or 7 days for short-acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair.
✓. Biologic (anti-neoplastic agent): At least 14 days after the last dose of a biologic agent. For agents that have known adverse events occurring beyond 14 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair.
✓. Immunotherapy: At least 42 days after the completion of any type of immunotherapy, example tumor vaccines.
✓. Monoclonal antibodies: At least 3 half-lives of the antibody after the last dose of a monoclonal antibody.
✓. X-ray telescope (XRT): At least 14 days after local palliative XRT (small port); At least 150 days must have elapsed if prior total body irradiation(TBI), craniospinal and/or entire spinal XRT or if \>=50% radiation of pelvis; At least 42 days must have elapsed if other substantial bone marrow (BM) radiation.