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NCT00616122 · ClinicalTrials.gov registry record · Phase 1
Sunitinib, Cyclophosphamide, and Methotrexate in Treating Patients With Metastatic Breast Cancer
A Phase 1 study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT00616122: Clinical Trial Phase 1 study, sponsored by University of California, San Francisco.
NCT00616122 is a Phase 1 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00616122, a Phase 1 study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and methotrexate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sunitinib together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of sunitinib when given together with cyclophosphamide and methotrexate to see how well they work in treating patients with metastatic breast cancer.
Primary Outcome
Patients in each cohort were followed for DLT for at least 8 weeks (2 week lead-in with sunitinib and 6 weeks of treatment with sunitinib and metronomic cyclophosphamide and methotrexate) before opening accrual to the next dose level. Dose limiting toxicity (DLT) defined as: 1) ≥ grade 3 anemia that does not resolve with appropriate growth factors afebrile grade 4 neutropenia that does not resolve with growth factor support after ≥ 7 days 2) grade 4 neutropenia associated with fever (1 reading o
Interventions
- OTHER laboratory biomarker analysis
- DRUG cyclophosphamide
- DRUG methotrexate
- DRUG sunitinib malate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2006-03-01 |
| Est. Completion | 2012-12-01 |
| Phase | Phase 1 |
Why NCT00616122 stopped before completion
NCT00616122 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT00616122 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00616122 about?
NCT00616122 is a clinical study titled "Sunitinib, Cyclophosphamide, and Methotrexate in Treating Patients With Metastatic Breast Cancer". RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and methotrexate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividi...
What is the current status of trial NCT00616122?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2006-03-01. Estimated completion is 2012-12-01.
What interventions are being tested in trial NCT00616122?
The interventions under investigation include: laboratory biomarker analysis (OTHER), cyclophosphamide (DRUG), methotrexate (DRUG), sunitinib malate (DRUG).
Who is sponsoring clinical trial NCT00616122?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00616122's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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