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NCT01918306 · ClinicalTrials.gov registry record · Phase 1
GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer
A Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT01918306 is a Phase 1 study that was terminated before completion, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 11 participants.
The verdict
NCT01918306, a Phase 1 study, was terminated before completion, sponsored by Vanderbilt-Ingram Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
This phase I/II trial study evaluates the tolerability and best tolerated dose of the PI3K inhibitor GDC-0941 when given with the chemotherapy cisplatin. This study will also examine how well the combination of GDC-0941 and cisplatin work in treating patients with androgen receptor negative triple negative metastatic breast cancer. Patients will be randomized to receive cisplatin alone or cisplatin with GDC-0941 in the phase II portion. Those receiving cisplatin alone can receive GDC-0941 upon progression of their disease. Cisplatin is a chemotherapy which has been shown to be effective in treating triple negative breast cancer. Preclinical studies show that adding a PI3K inhibitor such as GDC-0941 to cisplatin may be a more effective treatment for breast cancer.
Interventions
- OTHER laboratory biomarker analysis
- DRUG cisplatin
- OTHER pharmacological study
- PROCEDURE dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI
- DRUG GDC -0941
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2013-09 |
| Est. Completion | 2015-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01918306
The ClinicalTrials.gov registry entry for NCT01918306 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt-Ingram Cancer Center, which has 189 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT01918306 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01918306 about?
NCT01918306 is a clinical study titled "GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer". This phase I/II trial study evaluates the tolerability and best tolerated dose of the PI3K inhibitor GDC-0941 when given with the chemotherapy cisplatin. This study will also examine how well the combination of GDC-0941 and cisplatin work in treating patients with androgen receptor negative triple n...
What is the current status of trial NCT01918306?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2013-09. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01918306?
The interventions under investigation include: laboratory biomarker analysis (OTHER), cisplatin (DRUG), pharmacological study (OTHER), dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI (PROCEDURE), GDC -0941 (DRUG).
Who is sponsoring clinical trial NCT01918306?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
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