GDC-0941
DrugGDC-0941 will be administered QD orally for 5 consecutive days each week.
NCT Number: NCT01740336
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.
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Notify Me18 year and older
Female
Interventional
Phase 2
Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
GDC-0941 will be administered QD orally for 5 consecutive days each week.
Placebo matching to GDC-0941
Paclitaxel will be administered IV weekly for 3 out of 4 weeks in every 28-day cycle.
Time frame: From the time of randomization until disease progression or death from any cause (up to approximately 3 years)
Time frame: From randomization up to approximately 3 years
Time frame: From first observation of an objective tumor response until disease progression (up to approximately 3 years)
Time frame: From randomization until disease progression (up to approximately 3 years)
Time frame: From first observation of an objective tumor response until disease progression (up to approximately 3 years)
Time frame: Day 8 of Cycle 1 and Day 1 of Cycle 6 (cycle length=28 days)
Time frame: Day 1 of Cycle 1 (cycle length=28 days)
Genentech, Inc.
Industry
A Phase II, Randomized Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Patients With Locally Recurrent or Metastatic Breast Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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