Solid Tumors Clinical Trial
Official title:
A Phase 1 Dose Escalation and Pharmacodynamic Study of ARQ 761 (Beta-Lapachone) in Adult Patients With Advanced Solid Tumors
Primary Objective:
To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 761
administered intravenously.
Secondary Objectives:
To determine the pharmacokinetic profile of ARQ 761 To assess the preliminary anti-tumor
activity of aRQ 761
This is an open label, dose escalation study of (-)-trans-3-(5,6-dihydro-4H-pyrrolo
[3,2,1-ij] quinolin-1-yl)-4(1Hindol-3-yl) pyrrolidine-2,5-dione (ARQ) 761. Drug
administration regimen was designed in two parts.
Part I is a single-arm, non-randomized dose-escalation study. Part II is a multi-arm,
randomized dose-escalation study. It is designed to establish the clinical tolerability and
MTD of ARQ 761 and a recommended Phase 2 dose (RP2D). This is the first-in-human study with
ARQ 761.
Part I ARQ 761 will be administered intravenously at a starting dose of 195 mg/m2 IV once
weekly. A cycle for any patient already enrolled will consist of weekly administration of ARQ
761 with cycles repeated every 4 weeks (28 days).
Part II Alternate dosing regimen of ARQ 761 will be evaluated at a starting dose of 390
mg/m2. ARQ 761 will be administered intravenously at the assigned duration (2 h or 3 h)
weekly, biweekly or for two consecutive weeks followed by one week of rest. Patient will be
randomized to Arm A, B or C after enrollment.
Depending on toxicities observed, up to seven treatment cohorts will be enrolled with dose
escalation occurring by doubling (first escalation) and 40% increments thereafter. If dosing
is tolerated at all levels and pharmacokinetic data suggest continued escalation is
warranted, additional dose levels will be considered. Patients enrolled and assessed for dose
limiting toxicities (DLTs) will be eligible for intra-patient dose escalation.
Pharmacokinetic assessments will be performed on the first and the forth infusion days
following the different regimen to maintain continuity among all treatment groups. Safety and
tolerability of ARQ 761 will be assessed for the duration of study treatment. Evaluation of
potential anti-tumor activity of ARQ 761 will be performed at regular intervals while
patients remain on study. Dose escalation of ARQ 761 will proceed until the maximum tolerated
dose or recommended Phase 2 dose is reached.
Intra-patient escalation from lower dose levels to successfully administered dose levels will
be allowed. In order for patients at lower dose levels to be eligible for dose escalation,
they must tolerate therapy without experiencing any DLT. In addition, prior to escalation, a
complete cohort of three patients must have completed two cycles of therapy at the higher
dose level without experiencing any DLTs. Patients receiving doses of ARQ 761 may be
escalated a maximum of two times to the next consecutive cohorts.
Subjects will be enrolled according to a 3+3 dose escalation scheme. Treatment will be
staggered such that the first patient treated at each dose level will receive his or her
initial infusion at least 1 week prior to subsequent patients in the same cohort. At least 3
patients within a dose cohort must complete the first cycle of therapy prior to enrolling
subjects at the next dose level.
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