Clinical Trial of ARQ 761 in Advanced Solid Tumors
To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 761 administered intravenously.
To determine the pharmacokinetic profile of ARQ 761
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Dose Escalation and Pharmacodynamic Study of ARQ 761 (Beta-Lapachone) in Adult Patients With Advanced Solid Tumors|
- Maximum Tolerated Dose (MTD) [ Time Frame: Patients will receive an average of 4 cycles of ARQ 761 (corresponding with a treatment cycle of 16 weeks). ] [ Designated as safety issue: Yes ]To determine the recommended Phase 2 dose (RP2D) of ARQ 761 administered intravenously.
- Pharmacokinetic profile of ARQ761 [ Time Frame: Samples will be drawn from each subject during first and fourth infusion of study drug ] [ Designated as safety issue: Yes ]Serial venous blood samples will be drawn from each subject during first and fourth infusion of study drug to determine the plasma levels of ARQ761.If the same dose is not administered for the first and fourth infusion of study drug, PK samples will only be collected after the first dose. PK samples to be collected at pre-infusion, 15min,30min, 55min (5 mins before end of infusion), 75 min, 2,4,6,h post infusion, 24h, 48h, and 168h
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Drug: ARQ 761
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 be considered.
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 consecutive cohorts.
|Contact: David E Gerber, MDemail@example.com|
|Contact: Melana Lindsey, MHSA||2146487094||melana.Lindsey@utsouthwestern.edu|
|United States, Texas|
|UT Southwestern Medical Center - Simmons Cancer Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Principal Investigator: David E Gerber, MD|
|Principal Investigator:||David E Gerber, MD||University of Texas Southwestern Medical Center|