Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099190
Status:
COMPLETED
Last Update Posted:
2009-04-28
First Post:
2004-12-10
Brief Title:
ARQ 501 in Combination With Docetaxel in Patients With Cancer
Sponsor:
ArQule Inc a subsidiary of Merck Sharp Dohme LLC a subsidiary of Merck Co Inc Rahway NJ USA
Organization:
ArQule Inc a subsidiary of Merck Sharp Dohme LLC a subsidiary of Merck Co Inc Rahway NJ USA
Study Overview
Official Title:
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
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None