NCT04561817

To Evaluate the Safety and Efficacy of Ipatasertib (GDC-0068) in Combination With Paclitaxel in Platinum-resistant Recurrent Epithelial Ovarian Cancer

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ovarian Neoplasms

Interventions

Type	Name	Description
DRUG	Ipatasertib	400mg PO daily: day 1-21 of 28 day cycle
DRUG	Paclitaxel	80 mg/m2 IV weekly: day 1, 8, 15 of 28 day cycle

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-10-01
• Completion: 2023-10-01
• First posted: 2020-09-24
• Last updated: 2020-10-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study