ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer

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	Complete list of historical versions of study NCT00102700 on ClinicalTrials.gov Archive Site
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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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	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	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	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	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