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NCT01031446 · ClinicalTrials.gov registry record · Phase 1
Cisplatin, Paclitaxel, and Everolimus in Treating Patients With Metastatic Breast Cancer
A Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT01031446: Completed Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.
NCT01031446 is a Phase 1 study that has completed, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 55 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01031446, a Phase 1 study, has completed, sponsored by Vanderbilt-Ingram Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving cisplatin and paclitaxel together with everolimus may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects of giving cisplatin and paclitaxel together with everolimus and to see how well it works in treating patients with metastatic breast cancer.
Primary Outcome
The recommended dose for the Phase II trial will be the most prevalent dose delivered per week in Phase I that allows for safe and feasible administration of the medications.The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 or more of 3 patients experience dose-limiting toxicity (DLT) during the initial cycle of therapy. DLTs include Common Toxicity Criteria (CTC) Grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 0.5 x 10 9/L for \> 5 days), febrile neutro
Interventions
- OTHER laboratory biomarker analysis
- DRUG cisplatin
- DRUG paclitaxel
- DRUG everolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2009-10 |
| Est. Completion | 2017-08 |
| Phase | Phase 1 |
What the finished NCT01031446 record still lists
NCT01031446 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT01031446 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01031446 about?
NCT01031446 is a clinical study titled "Cisplatin, Paclitaxel, and Everolimus in Treating Patients With Metastatic Breast Cancer". RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and b...
What is the current status of trial NCT01031446?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2009-10. Estimated completion is 2017-08.
What interventions are being tested in trial NCT01031446?
The interventions under investigation include: laboratory biomarker analysis (OTHER), cisplatin (DRUG), paclitaxel (DRUG), everolimus (DRUG).
Who is sponsoring clinical trial NCT01031446?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01031446's enrollment target sits among peer trials
55 918th of 2000 higher than 1,070 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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