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NCT01624441 · ClinicalTrials.gov registry record · Phase 1
Dinaciclib and Epirubicin Hydrochloride in Treating Patients With Metastatic Triple-Negative Breast Cancer
A Phase 1 study of Recurrent Breast Carcinoma and HER2/Neu Negative, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT01624441: Completed Phase 1 study of Recurrent Breast Carcinoma and HER2/Neu Negative, sponsored by National Cancer Institute (NCI).
NCT01624441 is a Phase 1 study of Recurrent Breast Carcinoma and HER2/Neu Negative that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 40 participants, below the 289-participant average among 29 other Recurrent Breast Carcinoma trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01624441, a Phase 1 study of Recurrent Breast Carcinoma and HER2/Neu Negative, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I clinical trial studies the side effects and the best dose of dinaciclib when given together with epirubicin hydrochloride (epirubicin) in patients with metastatic (cancer that has spread to other parts of the body) triple-negative breast cancer. Dinaciclib is designed to stop cancer cells from dividing into new cancer cells. Epirubicin is designed to block the way cancer cells grow and divide and may slow or stop cancer cells from spreading throughout the body. Researchers want to find out what is the highest tolerable dose of the experimental drug dinaciclib that can be given in combination with epirubicin in patients with metastatic triple negative breast cancer.
Primary Outcome
The number (%) of DLTs will tabulate by dose level of dinaciclib.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Dinaciclib
- DRUG Epirubicin Hydrochloride
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-08-21 |
| Est. Completion | 2013-09-10 |
| Phase | Phase 1 |
What the finished NCT01624441 record still lists
NCT01624441 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 289-participant average among 29 other Recurrent Breast Carcinoma trials with a reported enrollment target (86% lower).
The record links to 7 conditions, with Recurrent Breast Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01624441 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01624441 about?
NCT01624441 is a clinical study titled "Dinaciclib and Epirubicin Hydrochloride in Treating Patients With Metastatic Triple-Negative Breast Cancer". This phase I clinical trial studies the side effects and the best dose of dinaciclib when given together with epirubicin hydrochloride (epirubicin) in patients with metastatic (cancer that has spread to other parts of the body) triple-negative breast cancer. Dinaciclib is designed to stop cancer cel...
What is the current status of trial NCT01624441?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2012-08-21. Estimated completion is 2013-09-10.
What conditions does trial NCT01624441 study?
This clinical trial studies the following conditions: Recurrent Breast Carcinoma, HER2/Neu Negative, Triple-Negative Breast Carcinoma, Estrogen Receptor Negative, Progesterone Receptor Negative.
What interventions are being tested in trial NCT01624441?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Dinaciclib (DRUG), Epirubicin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01624441?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01624441 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Breast Carcinoma
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 NCT01624441's enrollment target sits among peer trials
40 17th of 29 higher than 12 of 29 other Recurrent Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Breast Carcinoma 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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