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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: Clinical Trial Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.
NCT01918306 is a Phase 1 study that was terminated before completion, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
GDC-0941 dose will start at 260 mg (maximum dose). De-escalation of the intensity of the dose (if necessary) will proceed among cohorts of 3 patients according to a standard 3+3 algorithm beginning at the highest dose level of GDC-0941 260mg. MTD is defined as the highest dose at which a DLT is experienced \>= 1 out of 6 patients. A cohort of 3 patients was initially enrolled in the GDC-0941 arm at dose 260mg PO days 2-6, 9-13, 16-20, 23-27 of 28 day cycle 1. If no patient in the first cohort
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 |
Why NCT01918306 stopped before completion
NCT01918306 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT01918306 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01918306's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 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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