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ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00102700
Recruitment Status : Completed
First Posted : February 2, 2005
Last Update Posted : April 29, 2009
Sponsor:
Information provided by:
ArQule

Tracking Information
First Submitted Date  ICMJE February 1, 2005
First Posted Date  ICMJE February 2, 2005
Last Update Posted Date April 29, 2009
Study Start Date  ICMJE January 2005
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2006)
Document progression free survival after treatment with ARQ 501 and gemcitabine
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Phase Ib: Define a maximum tolerated dose of ARQ 501 in combination with gemcitabine
  • Phase II: Document progression free survival after treatment with ARQ 501 and gemcitabine
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2006)
Document safety and efficacy of ARQ 501 in combination with gemcitabine
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer
Official Title  ICMJE A Phase II Study of ARQ 501 in Combination With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pancreatic Cancer
  • Adenocarcinoma
Intervention  ICMJE Drug: ARQ 501 in combination with gemcitabine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: March 20, 2006)
66
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
87
Actual Study Completion Date  ICMJE January 2007
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00102700
Other Study ID Numbers  ICMJE ARQ 501-212
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE ArQule
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ArQule
Verification Date April 2009

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