Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by:
ArQule
ClinicalTrials.gov Identifier:
NCT00102700
First received: February 1, 2005
Last updated: April 28, 2009
Last verified: April 2009

February 1, 2005
April 28, 2009
January 2005
January 2007   (final data collection date for primary outcome measure)
Document progression free survival after treatment with ARQ 501 and gemcitabine
  • Phase II: Document progression free survival after treatment with ARQ 501 and gemcitabine
  • Phase Ib: Define a maximum tolerated dose of ARQ 501 in combination with gemcitabine
Complete list of historical versions of study NCT00102700 on ClinicalTrials.gov Archive Site
Document safety and efficacy of ARQ 501 in combination with gemcitabine
  • Phase Ib: Safety and tolerability of ARQ 501 in combination with gemcitabine
  • Phase II: Document safety and efficacy of ARQ 501 in combination with gemcitabine
Not Provided
Not Provided
 
ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer
A Phase II Study of ARQ 501 in Combination With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma

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.

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
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pancreatic Cancer
  • Adenocarcinoma
Drug: ARQ 501 in combination with gemcitabine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
January 2007
January 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have a pathologically confirmed diagnosis of unresectable, metastatic pancreatic adenocarcinoma
  • Be treatment-naïve.
  • Have measurable disease per RECIST Criteria.
  • Be ≥18 years old.
  • Have a Karnofsky Performance Status (KPS) of ≥70%.
  • Have an estimated life expectancy of ≥12 weeks.
  • Be male or a non-pregnant, non-lactating female patient. Patients who are fertile agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, or cervical cap) to avoid pregnancy.
  • Have a negative serum or urine pregnancy test within 7 days prior to the first dose of study drug (if patient is a female of childbearing potential).
  • Sign a written informed consent form.
  • Have adequate organ function as indicated by acceptable laboratory values obtained within 7 days prior to the first dose of study drug.

Exclusion Criteria:

  • Have received any prior therapy for the treatment of their pancreatic malignancy (including chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational).
  • Have an active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
  • Are pregnant or lactating.
  • Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
  • Have any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
  • Have symptomatic or untreated central nervous system (CNS) metastases.
  • Have a known hypersensitivity to gemcitabine.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00102700
ARQ 501-212
Not Provided
Not Provided
ArQule
Not Provided
Not Provided
ArQule
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP