ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer

• ClinicalTrials.gov Identifier: NCT00102700
• Recruitment Status: Completed
• First Posted: February 2, 2005
• Last Update Posted: April 29, 2009
• Sponsor: ArQule
• Information provided by: ArQule

Tracking Information

• First Submitted Date: February 1, 2005
• First Posted Date: February 2, 2005
• Last Update Posted Date: April 29, 2009
• Study Start Date: January 2005
• Actual Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 20, 2006): Document progression free survival after treatment with ARQ 501 and gemcitabine

Original Primary Outcome Measures (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

• Current Secondary Outcome Measures (submitted: March 20, 2006): Document safety and efficacy of ARQ 501 in combination with gemcitabine

Original Secondary Outcome Measures (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: ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Pancreatic Cancer
• Adenocarcinoma

• Intervention: Drug: ARQ 501 in combination with gemcitabine
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: March 20, 2006): 66
• Original Enrollment (submitted: June 23, 2005): 87
• Actual Study Completion Date: January 2007
• Actual Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00102700
• Other Study ID Numbers: ARQ 501-212
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: ArQule
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: ArQule
• Verification Date: April 2009