Clinical Trial of ARQ 761 in Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

91

Participants

Timeline

Start Date

December 29, 2011

Primary Completion Date

February 28, 2017

Study Completion Date

March 31, 2019

Conditions
Solid Tumors
Interventions
DRUG

ARQ 761

ARQ 761 will be 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

DRUG

ARQ 761 Weekly Administration

"If you decide to participate in this study ARQ 761 (beta lapachone) will be given to you through your vein once a week via a Portacath or Hickman line (a device that will make it easier to access your central vein that will be placed under your skin in your upper chest)~You will receive the same dose of ARQ761 each week for 8 weeks. The total infusion time will be determined by your physician, it may be either 2 or 3 hours.~The beginning dose level will be 390 mg/m2."

DRUG

Bi-Weekly Administration of ARQ 761

"If you decide to participate in this study ARQ 761 (beta lapachone) will be given to you through your vein bi-weekly via a Portacath or Hickman line (a device that will make it easier to access your central vein that will be placed under your skin in your upper chest)~You will receive the same dose of ARQ761 bi-weekly for 8 weeks. The total infusion time will be determined by your physician, it may be either 2 or 3 hours.~The beginning dose level will be 390 mg/m2."

DRUG

Two Consecutive Weeks Administration of ARQ 761 with one week of rest

"If you decide to participate in this study ARQ 761 (beta lapachone) will be given to you through your vein once a week via a Portacath or Hickman line (a device that will make it easier to access your central vein that will be placed under your skin in your upper chest)~You will receive the same dose of ARQ761 for 2 consecutive weeks followed by one week of rest for 6 weeks. The total infusion time will be determined by your physician, it may be either 2 or 3 hours.~The beginning dose level will be 390 mg/m2."

Trial Locations (1)

75390

UT Southwestern Medical Center - Simmons Cancer Center, Dallas

All Listed Sponsors
collaborator

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

INDUSTRY

lead

University of Texas Southwestern Medical Center

OTHER

NCT01502800 - Clinical Trial of ARQ 761 in Advanced Solid Tumors | Biotech Hunter | Biotech Hunter