ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer
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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
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Sponsor:
ArQule
Information provided by:
ArQule
Tracking Information | |||
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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 |
Document progression free survival after treatment with ARQ 501 and gemcitabine | ||
Original Primary Outcome Measures ICMJE |
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Change History | |||
Current Secondary Outcome Measures ICMJE |
Document safety and efficacy of ARQ 501 in combination with gemcitabine | ||
Original Secondary Outcome Measures ICMJE |
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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:
Secondary Objectives:
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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 |
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Condition ICMJE |
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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. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Enrollment ICMJE |
66 | ||
Original Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |