Pharmacogenomics Blood Sampling Protocol For Irinotecan/Fluorouracil/Leucovorin(CPT-11/FU/LV).
NCT00140036
Last updated date
ABOUT THIS STUDY
This protocol describes procedures for the collection of blood samples for the intent of
determining genetic contribution to the safety and efficacy of CPT/FU/LV.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Colorectal Neoplasms
Sex
Females and Males
Age
18 + years
Inclusion Criteria
Show details
- Participation in studies employing treatment with irinotecan and a signed informed consent.
Exclusion Criteria
Show details
- None.
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Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Pharmacogenomics Blood Sampling Protocol For Irinotecan/Fluorouracil/Leucovorin(CPT-11/FU/LV). | |||
Official Title ICMJE | Pharmacogenomics Blood Sampling Protocol For Irinotecan/Fluorouracil/Leucovorin(CPT-11/FU/LV). | |||
Brief Summary | This protocol describes procedures for the collection of blood samples for the intent of determining genetic contribution to the safety and efficacy of CPT/FU/LV. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Colorectal Neoplasms | |||
Intervention ICMJE | Procedure: Blood draw | |||
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. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 137 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | August 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 | Canada, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00140036 | |||
Other Study ID Numbers ICMJE | CPTAIV-0020-366 A5961020 | |||
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 | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | February 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |