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NCT02672475 · ClinicalTrials.gov registry record · Phase 1
Galunisertib and Paclitaxel in Treating Patients With Metastatic Androgen Receptor Negative (AR-) Triple Negative Breast Cancer
A Phase 1 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma, sponsored by Vanderbilt-Ingram Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT02672475: Completed Phase 1 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma, sponsored by Vanderbilt-Ingram Cancer Center.
NCT02672475 is a Phase 1 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma that has completed, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 29 participants, below the 66-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02672475, a Phase 1 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma, has completed, sponsored by Vanderbilt-Ingram Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best dose of Galunisertib when given together with paclitaxel in treating patients with androgen receptor negative or triple negative breast cancer that has spread to other places in the body. Some tumors need growth factors, which are made by the body's white blood cells, to keep growing. Galunisertib may interfere with growth factors and help cause tumor cells to die. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Galunisertib together with paclitaxel may kill more tumor cells.
Primary Outcome
Adverse events will be classified by type, incidence, severity and causality. All adverse events will be summarized by patient and dose level.of galunisertib in combination with paclitaxel graded by National Cancer Institute Common Terminology Criteria For Adverse Events (NCI CTCAE) version 4.03
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Paclitaxel
- DRUG Galunisertib
Study Locations (1)
Tennessee
- Vanderbilt University/Ingram Cancer Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2016-03 |
| Est. Completion | 2023-08 |
| Phase | Phase 1 |
What the finished NCT02672475 record still lists
NCT02672475 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 66-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (56% lower).
The record links to 6 conditions, with Stage IV Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02672475 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT02672475 about?
NCT02672475 is a clinical study titled "Galunisertib and Paclitaxel in Treating Patients With Metastatic Androgen Receptor Negative (AR-) Triple Negative Breast Cancer". This phase I trial studies the side effects and best dose of Galunisertib when given together with paclitaxel in treating patients with androgen receptor negative or triple negative breast cancer that has spread to other places in the body. Some tumors need growth factors, which are made by the body...
What is the current status of trial NCT02672475?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2016-03. Estimated completion is 2023-08.
What conditions does trial NCT02672475 study?
This clinical trial studies the following conditions: Stage IV Breast Cancer, Recurrent Breast Carcinoma, HER2/Neu Negative, Triple-Negative Breast Carcinoma, Estrogen Receptor Negative.
What interventions are being tested in trial NCT02672475?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), Galunisertib (DRUG).
Who is sponsoring clinical trial NCT02672475?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02672475 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV Breast Cancer
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 NCT02672475's enrollment target sits among peer trials
29 19th of 30 higher than 12 of 30 other Stage IV Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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