Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Breast Cancer
NCT00802945 · View on ClinicalTrials.gov ↗
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.
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00802945
The ClinicalTrials.gov registry entry for NCT00802945 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nektar Therapeutics, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00802945 reports 19 study locations spanning 7 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00802945?
The interventions under investigation include: NKTR-102 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00802945?
This trial is sponsored by Nektar Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.