Trials / Completed
CompletedNCT01740336
A Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Participants With Locally Recurrent or Metastatic Breast Cancer
A Phase II, Randomized Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Patients With Locally Recurrent or Metastatic Breast Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 183 (actual)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This multicenter, randomized, single-blind, placebo-controlled, two arm study will evaluate the efficacy and safety of paclitaxel with GDC-0941 versus paclitaxel with placebo in participants with locally recurrent or metastatic breast cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GDC-0941 | GDC-0941 will be administered QD orally for 5 consecutive days each week. |
| DRUG | Placebo | Placebo matching to GDC-0941 |
| DRUG | Paclitaxel | Paclitaxel will be administered IV weekly for 3 out of 4 weeks in every 28-day cycle. |
Timeline
- Start date
- 2013-02-06
- Primary completion
- 2015-10-20
- Completion
- 2015-12-10
- First posted
- 2012-12-04
- Last updated
- 2017-04-24
Locations
97 sites across 8 countries: United States, Australia, Austria, Belgium, Czechia, South Korea, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01740336. Inclusion in this directory is not an endorsement.