Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00507091
First received: July 10, 2007
Last updated: April 3, 2009
Last verified: April 2009
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 10, 2007 | ||||||||
| Last Updated Date | April 3, 2009 | ||||||||
| Start Date ICMJE | August 2005 | ||||||||
| Primary Completion Date | May 2006 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Establish the safety & efficacy of ZD6474 w/5-fluorouracil,leucovorin & oxaliplatin to patients with advanced colorectal adenocarcinoma, by assessment of AEs, vital signs, clinical chemistry, hematology, urinalysis, ECG and physical examinations [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Establish the safety & efficacy of ZD6474 w/5-fluorouracil,lecovorin & oxaliplatin to patients with advanced colorectal adenocarcinoma, by assessment of AEs, vital signs, clinical chemistry, haematology, urinalysis, ECG and physical examinations | ||||||||
| Change History | Complete list of historical versions of study NCT00507091 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination | ||||||||
| Official Title ICMJE | A Phase I Open Label Study to Asses the Safety and Tolerability of ZD6474 (Vandetanib)in Combination With Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as First or Second Line Therapy in Patients With Metastatic Colorectal Adenocarcinoma. | ||||||||
| Brief Summary | A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic colorectal adenocarcinoma. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* 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 | 22 | ||||||||
| Completion Date | June 2008 | ||||||||
| Primary Completion Date | May 2006 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Belgium, United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00507091 | ||||||||
| Other Study ID Numbers ICMJE | D4200C00038 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | AstraZeneca | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | ||||||||
| Verification Date | April 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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