A Phase Ib Safety and Pharmacokinetic Study of ARQ 501 in Combination With Docetaxol in Adult Patients With Locally Advanced or Metastatic Carcinoma
ARQ 501 has demonstrated activity in vitro against a wide range of solid tumors including
lung, colorectal, breast, prostate, pancreatic, ovarian, and myeloma. To date, no
histological cancer type studied appears inherently resistant to treatment with ARQ 501. In
animal xenograft models of human tumors, ARQ 501 monotherapy has been effective in treating
ovarian, colon, prostate, and breast cancer. When used in combination with taxane therapy,
ARQ 501 has demonstrated efficacy in treating a variety of human cancers, including ovarian,
breast, and colon.
This study is designed to explore whether the addition of ARQ 501 to a once every three week
schedule of docetaxel is a safe and tolerable regimen. The study is designed to collect
safety and pharmacokinetic data on the combination regimen and to measure the antitumor
activity observed in patients.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the safety and tolerability of ARQ 501 in combination with docetaxel
C. Casey Cunningham, MD
Principal Investigator
Mary Crowley Medical Research Center
United States: Food and Drug Administration
ARQ 501-111
NCT00099190
December 2004
November 2006
Name | Location |
---|---|
Mary Crowley Medical Research Center | Dallas, Texas 75246 |