AZD2281 and Irinotecan in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
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ClinicalTrials.gov Identifier: NCT00535353 |
Recruitment Status
:
Completed
First Posted
: September 26, 2007
Last Update Posted
: May 3, 2016
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Tracking Information | ||||
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First Submitted Date ICMJE | September 25, 2007 | |||
First Posted Date ICMJE | September 26, 2007 | |||
Last Update Posted Date | May 3, 2016 | |||
Study Start Date ICMJE | August 2007 | |||
Actual Primary Completion Date | September 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00535353 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | AZD2281 and Irinotecan in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer | |||
Official Title ICMJE | A Phase I Study of AZD2281 in Combination With Irinotecan in Patients With Locally Advanced or Metastatic Incurable Colorectal Cancer | |||
Brief Summary | RATIONALE: AZD2281 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving AZD2281 together with irinotecan may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of AZD2281 and irinotecan in treating patients with locally advanced or metastatic colorectal cancer. |
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Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of AZD2281 and irinotecan hydrochloride.
Patients undergo cheek swabs, tumor tissue, and blood sample collection periodically for pharmacokinetic, pharmacodynamic, and correlative studies. After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Colorectal Cancer | |||
Intervention ICMJE |
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Study Arms | Not Provided | |||
Publications * | Chen EX, Jonker DJ, Siu LL, McKeever K, Keller D, Wells J, Hagerman L, Seymour L. A Phase I study of olaparib and irinotecan in patients with colorectal cancer: Canadian Cancer Trials Group IND 187. Invest New Drugs. 2016 Aug;34(4):450-7. doi: 10.1007/s10637-016-0351-x. Epub 2016 Apr 13. | |||
* 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 |
26 | |||
Original Enrollment ICMJE |
30 | |||
Actual Study Completion Date | February 2015 | |||
Actual Primary Completion Date | September 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Sex/Gender |
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Ages | 18 Years to 70 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00535353 | |||
Other Study ID Numbers ICMJE | I187 CAN-NCIC-IND187 ( Registry Identifier: NCI US - Physician Data Query ) IND187 ( Other Identifier: NCIC CTG ) CDR0000565189 ( Other Identifier: PDQ ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Canadian Cancer Trials Group ( NCIC Clinical Trials Group ) | |||
Study Sponsor ICMJE | NCIC Clinical Trials Group | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Canadian Cancer Trials Group | |||
Verification Date | February 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |