NCT00099190

ARQ 501 in Combination With Docetaxel in Patients With Cancer

A Phase Ib Safety and Pharmacokinetic Study of ARQ 501 in Combination With Docetaxol in Adult Patients With Locally Advanced or Metastatic Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (planned)
• Sponsor: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety of ARQ 501 in combination with docetaxel in patients with advanced or metastatic cancer. In addition, the study is designed to observe the potential the combination of ARQ 501 and docetaxel have in treating cancer.

Detailed description

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.

Conditions

• Carcinoma

Interventions

Type	Name	Description
DRUG	ARQ 501

Timeline

• Start date: 2004-12-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2004-12-10
• Last updated: 2009-04-28

Locations

1 site across 1 country: United States