A Phase 1 Dose Escalation and Pharmacodynamic Study of ARQ 761 (Beta-Lapachone) in Adult Patients With Advanced Solid Tumors
This is an open label, dose escalation study of ARQ 761 administered intravenously at a
starting dose of 195 mg/m2 IV once weekly. 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
Pharmacokinetic assessments will be performed on days 1 and 15 of the first cycle. 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.
Patients receiving doses of ARQ 761 may be escalated a maximum of two times to the next
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
To determine the recommended Phase 2 dose (RP2D) of ARQ 761 administered intravenously.
Patients will receive an average of 4 cycles of ARQ 761 (corresponding with a treatment cycle of 16 weeks).
David E Gerber, MD
University of Texas Southwestern Medical Center
United States: Food and Drug Administration
Ph1 ARQ 761
|UT Southwestern Medical Center - Simmons Cancer Center||Dallas, Texas 75390|