Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102700
Status:
COMPLETED
Last Update Posted:
2009-04-29
First Post:
2005-02-01
Brief Title:
ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic 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 II Study of ARQ 501 in Combination With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
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 study will document the safety and efficacy of the combination of ARQ 501 and gemcitabine in patients with treatment-naïve unresectable metastatic pancreatic adenocarcinoma
Detailed Description:
This is a single-arm non-randomized study of ARQ 501 in combination with gemcitabine in adult patients with treatment-naïve unresectable metastatic pancreatic adenocarcinoma The study objectives are
Primary Objective
Assess the overall response rate ORR of patients treated with ARQ 501 in combination with gemcitabine
Secondary Objectives
Determine time to tumor progression TTP of patients treated with ARQ 501 in combination with gemcitabine
Further characterize the safety of ARQ 501 in combination with gemcitabine
Primary Objective
Assess the overall response rate ORR of patients treated with ARQ 501 in combination with gemcitabine
Secondary Objectives
Determine time to tumor progression TTP of patients treated with ARQ 501 in combination with gemcitabine
Further characterize the safety of ARQ 501 in combination with gemcitabine
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