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NCT00454649 · ClinicalTrials.gov registry record · Phase 1
Investigational Agent AG-013736 In Combinations With Standard Of Care Treatments For Patient's With Advanced Solid Tumor
A Phase 1 study of Neoplasms, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 102
- Enrollment target
- 13
- Study locations
NCT00454649: Completed Phase 1 study of Neoplasms, sponsored by Pfizer.
NCT00454649 is a Phase 1 study of Neoplasms that has completed, run by Pfizer. The registered enrollment target is 102 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (94% lower). The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00454649, a Phase 1 study of Neoplasms, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 102 participants
- Enrollment target
- 13
- Study locations
Study Summary
To determine the best dose of this investigational agent AG-013736 in combination with various standard of care treatments for advanced solid tumors.
Primary Outcome
MTD defined as the dose level at which more than 1 out of 6 participants experienced a dose limiting toxicity (DLT). DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (\>=) Gr 3 nonhematological toxicities or \>=0.5 teaspoon/day hemoptysis or \>=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.
Conditions Studied
Interventions
- DRUG Axitinib + Paclitaxel + Carboplatin (Cohort 1)
- DRUG Axitinib + Paclitaxel + Carboplatin (Cohort 2)
- DRUG Axitinib + Paclitaxel + Carboplatin (Cohort 3)
- DRUG Axitinib + Paclitaxel (Cohort 4)
- DRUG Axitinib + Docetaxel + Carboplatin (Cohort 4a)
Study Locations (13)
Illinois
- Pfizer Investigational Site - Harvey
- Pfizer Investigational Site - Harvey
- Pfizer Investigational Site - Tinley Park
Georgia
- Pfizer Investigational Site - Augusta
- Pfizer Investigational Site - Augusta
Indiana
- Pfizer Investigational Site - Hobart
- Pfizer Investigational Site - Munster
Pennsylvania
- Pfizer Investigational Site - Philadelphia
Texas
- Pfizer Investigational Site - Houston
Washington
- Pfizer Investigational Site - Kennewick
Other
- Pfizer Investigational Site - Warsaw
Barcelona
- Pfizer Investigational Site - Barcelona
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2005-12 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
What the finished NCT00454649 record still lists
NCT00454649 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Axitinib + Paclitaxel + Carboplatin (Cohort 1) is the first listed.
NCT00454649 lists 13 locations in 9 states (Illinois, Georgia, Indiana).
Frequently Asked Questions
What is clinical trial NCT00454649 about?
NCT00454649 is a clinical study titled "Investigational Agent AG-013736 In Combinations With Standard Of Care Treatments For Patient's With Advanced Solid Tumor". To determine the best dose of this investigational agent AG-013736 in combination with various standard of care treatments for advanced solid tumors.
What is the current status of trial NCT00454649?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 102 participants. The study started on 2005-12. Estimated completion is 2011-04.
What conditions does trial NCT00454649 study?
This clinical trial studies the following conditions: Neoplasms.
What interventions are being tested in trial NCT00454649?
The interventions under investigation include: Axitinib + Paclitaxel + Carboplatin (Cohort 1) (DRUG), Axitinib + Paclitaxel + Carboplatin (Cohort 2) (DRUG), Axitinib + Paclitaxel + Carboplatin (Cohort 3) (DRUG), Axitinib + Paclitaxel (Cohort 4) (DRUG), Axitinib + Docetaxel + Carboplatin (Cohort 4a) (DRUG).
Who is sponsoring clinical trial NCT00454649?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00454649 being conducted?
This trial has 13 study locations across Georgia, Illinois, Indiana, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neoplasms
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 NCT00454649's enrollment target sits among peer trials
102 71st of 158 higher than 88 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms 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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