Study to Assess the Safety & Tolerability of a PARP Inhibitor in Combination With Gemcitabine in Pancreatic Cancer

• ClinicalTrials.gov Identifier: NCT00515866
• Recruitment Status: Completed
• First Posted: August 14, 2007
• Last Update Posted: December 20, 2013
• Sponsor: AstraZeneca
• Information provided by (Responsible Party): AstraZeneca

Tracking Information

• First Submitted Date: August 13, 2007
• First Posted Date: August 14, 2007
• Last Update Posted Date: December 20, 2013
• Study Start Date: August 2007
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 5, 2008): 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 (submitted: August 13, 2007): To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with gemcitabine
• Current Secondary Outcome Measures (submitted: December 15, 2007): To identify the dose-limiting toxicity of the combination therapy [ Time Frame: assessed at each visit ]
• Original Secondary Outcome Measures (submitted: August 13, 2007): 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: Study to Assess the Safety & Tolerability of a PARP Inhibitor in Combination With Gemcitabine in Pancreatic Cancer
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pancreatic Neoplasms

Intervention

• Drug: KU-0059436 (AZD2281)(PARP inhibitor)
  oral
  Other Name: Olaparib
• Drug: Gemcitabine
  intravenous injection
  Other Names:

  • Gemzar®
  • Gemcitabine HCL

Study Arms

Experimental: 1

Gemcitabine + KU-0059436

Interventions:

• Drug: KU-0059436 (AZD2281)(PARP inhibitor)
• Drug: Gemcitabine

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 14, 2012): 68
• Original Estimated Enrollment (submitted: August 13, 2007): 69
• Actual Study Completion Date: July 2012
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of pancreas
• Locally advanced or metastatic unresectable disease

Exclusion Criteria:

• No prior anti cancer chemotherapy, radiotherapy (except palliative >4 weeks prior to entry, endocrine or immunotherapy or use of other investigational agents;

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 Kingdom, United States
• Removed Location Countries: Germany

Administrative Information

• NCT Number: NCT00515866
• Other Study ID Numbers: KU36-29; D0810C00005
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: AstraZeneca
• Study Sponsor: AstraZeneca
• Collaborators: Not Provided

Investigators

• Principal Investigator: Howard A Burris III, MD; The Sarah Cannon Cancer Center
• Study Director: Jane Robertson, BSc, MBCHB, MD; AstraZeneca

• PRS Account: AstraZeneca
• Verification Date: December 2013