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NCT00563316 · ClinicalTrials.gov registry record · Phase 1
Effect of Panitumumab on the Pharmacokinetics of Irinotecan
A Phase 1 study of Metastatic Colorectal Cancer, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 12
- Study locations
NCT00563316: Completed Phase 1 study of Metastatic Colorectal Cancer, sponsored by Amgen.
NCT00563316 is a Phase 1 study of Metastatic Colorectal Cancer that has completed, run by Amgen. The registered enrollment target is 28 participants, below the 185-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (85% lower). The trial reports 12 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00563316, a Phase 1 study of Metastatic Colorectal Cancer, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 12
- Study locations
Study Summary
The primary objective of this study is to determine if panitumumab affects the pharmacokinetic (PK) profile of irinotecan.
Primary Outcome
To analyze the effect, if any, that panitumumab had on the pharmacokinetics of irinotecan, the Cmax of irinotecan administered alone (Cycle 1) and with concomitant panitumumab (Cycle 2) was measured. Plasma samples were assayed by a validated high performance liquid chromatography (HPLC)-fluorescence method for the measurement of irinotecan. The lower limit of quantitation (LLOQ) was 2 ng/mL.
Conditions Studied
Interventions
- DRUG Irinotecan
- DRUG Panitumumab
Study Locations (12)
Montana
- Research Site - Billings
- Research Site - Billings
North Carolina
- Research Site - Chapel Hill
- Research Site - Chapel Hill
Pennsylvania
- Research Site - Philadelphia
- Research Site - Philadelphia
Tennessee
- Research Site - Nashville
- Research Site - Nashville
British Columbia
- Research Site - Vancouver
- Research Site - Vancouver
Ontario
- Research Site - Toronto
- Research Site - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2008-03 |
| Est. Completion | 2010-06 |
| Phase | Phase 1 |
What the finished NCT00563316 record still lists
NCT00563316 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 185-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Metastatic Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions - of which Irinotecan is the first listed.
NCT00563316 lists 12 locations in 6 states (Montana, North Carolina, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT00563316 about?
NCT00563316 is a clinical study titled "Effect of Panitumumab on the Pharmacokinetics of Irinotecan". The primary objective of this study is to determine if panitumumab affects the pharmacokinetic (PK) profile of irinotecan.
What is the current status of trial NCT00563316?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2008-03. Estimated completion is 2010-06.
What conditions does trial NCT00563316 study?
This clinical trial studies the following conditions: Metastatic Colorectal Cancer.
What interventions are being tested in trial NCT00563316?
The interventions under investigation include: Irinotecan (DRUG), Panitumumab (DRUG).
Who is sponsoring clinical trial NCT00563316?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00563316 being conducted?
This trial has 12 study locations across Montana, North Carolina, Pennsylvania, Tennessee, British Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00563316's enrollment target sits among peer trials
28 37th of 45 higher than 9 of 45 other Metastatic Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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