Ovarian Neoplasms Clinical Trial
Official title:
An Open Label Phase II Study to Evaluate the Safety and Efficacy of Ipatasertib (GDC-0068) in Combination With Paclitaxel in Platinum-resistant Recurrent Epithelial Ovarian Cancer
This is a phase II open label, non-randomized, study to evaluate the safety and efficacy of Ipatasertib (GDC-0068) in combination with paclitaxel in platinum-resistant recurrent epithelial ovarian cancer.
This is a phase II open label, non-randomized, study to evaluate the safety and efficacy of
Ipatasertib (GDC-0068) in combination with paclitaxel in platinum-resistant recurrent
epithelial ovarian cancer.
The primary objective of the study is to determine - the safety and objective response rate
of treatment with ipatasertib (GDC-0068) in combination with paclitaxel in platinum-resistant
recurrent epithelial ovarian cancer at week 12 for two cohorts of patients: with PI3K/AKT
mutations (altered) and without PI3K/AKT mutations (non-altered)
About 39 patients will participate in the study and the accrual will take place over a course
of 30 months Patients will be treated until disease progression and followed for 1 year
thereafter.
The two drugs are ipatasertib and paclitaxel.
- Ipatasertib will be given 400mg PO daily: day 1-21 of 28 day cycle
- Paclitaxel will be given 80mg/m2 IV weekly: day 1, 8, 15 of 28 day cycle
The study hypothesis is that the combination of Ipatasertib (GDC-0068) plus paclitaxel will
safely induce a tumor response and increase the objective response rate in patients with
platinum-resistant recurrent epithelial ovarian cancer, with or without PI3K/AKT mutations.
This trial will enroll patients with platinum-resistant recurrent epithelial ovarian cancer.
Given the relatively poor prognosis and limited treatment options for these patients, this
population is considered appropriate for trials of novel therapeutic candidates. The
benefit-risk ratio for ipatasertib in combination with paclitaxel is expected to be
acceptable in this setting.
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