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

NCT04561817 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-10-06

No results posted yet for this study

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.

Conditions

  • Ovarian Neoplasms

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Amy Tiersten, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-10-01
Completion
2023-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04561817 on ClinicalTrials.gov