Solid Tumors Clinical Trial
Official title:
An Open-label, Multicenter, Multiple Dose, Phase 1 Study to Establish the Maximum Tolerated Dose of E7389 Liposomal Formulation in Patients With Solid Tumors
Study E7389-E044-112 is a Phase 1 study designed to assess the safety, tolerability and preliminary efficacy of eribulin-liposomal formulation (E7389-LF) in patients with solid tumors. This dose-escalation study will determine the maximum tolerated dose, dosing schedules tested, the dose schedule regimen with a more favorable tolerability profile, and a preliminary indication of efficacy.
This is a Phase 1 first-in-human, non-randomized (individuals will not be assigned by chance
to study treatments), open-label (individuals will know the identity of study treatments),
multicenter, 2-part, dose-escalation study to evaluate the safety, pharmacokinetics (study of
what the body does to a drug) of eribulin-LF administered intravenously to patients with
solid tumors. Each treatment cycle will be 21 days (Schedule 1) or 28 days (Schedule 1a or
2). Part 1 is the dose-escalation phase, which will be guided by pharmacokinetics and safety.
Three to 6 new patients will be enrolled in sequential cohorts (first cohort will receive the
starting dose and subsequent cohorts will receive increased doses of eribulin-LF). Enrollment
in each cohort will be staggered; the second and third participant in every cohort will not
be dosed until the first patient in that cohort completes 2 weeks of Cycle 1. If no
dose-limiting toxicities (DLTs) have been observed during the first 2 week of Cycle 1 in the
first patient, the second and third patients in the cohort will initiate treatment.
Enrollment will be first initiated into cohort 1 of Schedule 1 (dosing on Day 1 of 21 day
cycle). Interim analysis will be conducted upon completion of this cohort. The following
decisions will be made based upon the results of the interim analysis 1) proceed with
escalating to next dose level (cohort 2) of Schedule 1 (dosing on Day 1 of 21 day cycle) and
initiate cohort 1 of Schedule 2 (dosing on Day 1 and Day 15 of 28 day cycle), or 2)
discontinue plans to evaluate Schedule 2 and initiate Schedule 1a (dosing on Day 1 of 28 day
cycle).
After the last patient in each cohort completes Cycle 1, the safety for DLT determination
will be evaluated and a decision will be made on whether to escalate the dose in a new cohort
of 3 to 6 new patients. Dose escalation will halt when the maximum tolerated dose (MTD) is
reached. The total number of patients to be enrolled in Part 1 will depend on the dose level
at which the DLT will be achieved. After MTD for each schedule is determined, patients will
be enrolled into Expansion Part of the study to confirm safety and tolerability of each
dosing schedule. Nine to 12 patients will be treated with MTD for each schedule for 6 cycles.
The total study duration for each participant will be approximately 18 months.
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