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NCT00802945 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Breast Cancer
A Phase 2 study of Breast Cancer and Tumor, sponsored by Nektar Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 19
- Study locations
NCT00802945: Completed Phase 2 study of Breast Cancer and Tumor, sponsored by Nektar Therapeutics.
NCT00802945 is a Phase 2 study of Breast Cancer and Tumor that has completed, run by Nektar Therapeutics. The registered enrollment target is 70 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 19 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00802945, a Phase 2 study of Breast Cancer and Tumor, has completed, sponsored by Nektar Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 19
- Study locations
Study Summary
This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients with metastatic or locally advanced breast cancer whose disease has failed prior taxane-based treatment in the metastatic setting. Patients will be randomized 1:1 into one of two treatment arms. NKTR 102 will be administered at a dose level of 145 mg/m2 in both arms. In Arm A, NKTR-102 will be given on a q14d schedule. In Arm B, NKTR-102 will be given on a q21d schedule. Approximately 70 patients may be evaluated in this study with approximately 35 patients enrolled in each treatment arm.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Conditions Studied
Interventions
- DRUG NKTR-102
Study Locations (19)
Other
- Institut Jules Bordet - Brussels
- UZ Antwerpen - Edegem
- De Pintelaan 1885 - Ghent
- CHU de Liege - Liège
- GasthuisZusters Antwerpen - Wilrijk
- Clatterbridge Centre for Oncology - Bebington
- Velindre Hospital - Cardiff
- Beatson Oncology Center - Glasgow
- St James University Hospital - Leed
- Nottingham City Hospital - Nottingham
- Weston Park Hospital - Sheffield
California
- USC Norris Comprehensive Cancer Center - Los Angeles
- Desert Hematology Oncology Medical Group - Rancho Mirage
- Stockton Hematology/Oncology - Stockton
Florida
- Mayo Clinic Jacksonville - Jacksonville
Kentucky
- Louisville Oncology Clinical Research Program - Louisville
Minnesota
- Mayo Clinic Rochester - Rochester
Rhode Island
- Pharma Resource - East Providence
Virginia
- University of Virginia Health System - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2008-10 |
| Est. Completion | 2012-01 |
| Phase | Phase 2 |
What the finished NCT00802945 record still lists
NCT00802945 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which NKTR-102 is the first listed.
NCT00802945 lists 19 locations in 7 states (Other, California, Florida).
Frequently Asked Questions
What is clinical trial NCT00802945 about?
NCT00802945 is a clinical study titled "Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Breast Cancer". This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients with metastatic or locally advanced breast cancer whose disease has failed prior taxane-based treatment in the metastatic setting. Patients will be randomized 1:1 into one of two treatment arms. NKTR 102 will...
What is the current status of trial NCT00802945?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2008-10. Estimated completion is 2012-01.
What conditions does trial NCT00802945 study?
This clinical trial studies the following conditions: Breast Cancer, Tumor.
What interventions are being tested in trial NCT00802945?
The interventions under investigation include: NKTR-102 (DRUG).
Who is sponsoring clinical trial NCT00802945?
This trial is sponsored by Nektar Therapeutics, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00802945 being conducted?
This trial has 19 study locations across California, Florida, Kentucky, Minnesota, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00802945's enrollment target sits among peer trials
70 696th of 1224 higher than 521 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast 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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