Trial record 1 of 2 for:
olaparib | Pancreatic cancer | United Kingdom
Study to Assess the Safety & Tolerability of a PARP Inhibitor in Combination With Gemcitabine in 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: NCT00515866 |
Recruitment Status :
Completed
First Posted : August 14, 2007
Last Update Posted : December 20, 2013
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
Tracking Information | |||||||
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First Submitted Date ICMJE | August 13, 2007 | ||||||
First Posted Date ICMJE | August 14, 2007 | ||||||
Last Update Posted Date | December 20, 2013 | ||||||
Study Start Date ICMJE | August 2007 | ||||||
Actual Primary Completion Date | October 2011 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
To establish the maximum tolerated dose (MTD) or a tolerable and effective dose of KU 0059436 in combination with gemcitabine [ Time Frame: assessed at each visit ] | ||||||
Original Primary Outcome Measures ICMJE |
To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with gemcitabine | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
To identify the dose-limiting toxicity of the combination therapy [ Time Frame: assessed at each visit ] | ||||||
Original Secondary Outcome Measures ICMJE |
To identify the dose-limiting toxicity of the combination therapy | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Study to Assess the Safety & Tolerability of a PARP Inhibitor in Combination With Gemcitabine in Pancreatic Cancer | ||||||
Official Title ICMJE | A Phase I, Open Label, Study of the Safety and Tolerability of KU-0059436 in Combination With Gemcitabine in the Treatment of Patients With Advanced Solid Tumours | ||||||
Brief Summary | The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with gemcitabine chemotherapy for the treatment of pancreatic cancer. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Pancreatic Neoplasms | ||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: 1
Gemcitabine + KU-0059436
Interventions:
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Publications * | Bendell J, O'Reilly EM, Middleton MR, Chau I, Hochster H, Fielding A, Burke W, Burris H 3rd. Phase I study of olaparib plus gemcitabine in patients with advanced solid tumours and comparison with gemcitabine alone in patients with locally advanced/metastatic pancreatic cancer. Ann Oncol. 2015 Apr;26(4):804-811. doi: 10.1093/annonc/mdu581. Epub 2015 Jan 7. | ||||||
* 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 | ||||||
Actual Enrollment ICMJE |
68 | ||||||
Original Estimated Enrollment ICMJE |
69 | ||||||
Actual Study Completion Date ICMJE | July 2012 | ||||||
Actual Primary Completion Date | October 2011 (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 Kingdom, United States | ||||||
Removed Location Countries | Germany | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00515866 | ||||||
Other Study ID Numbers ICMJE | KU36-29 D0810C00005 |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | AstraZeneca | ||||||
Study Sponsor ICMJE | AstraZeneca | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | AstraZeneca | ||||||
Verification Date | December 2013 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |