A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

Summary

This study will evaluate the efficacy and safety of multiple biomarker-selected treatments in patients with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal tumors. Enrollment will take place in two phases: a preliminary phase followed by a potential expansion phase.

Conditions

• Ovarian Cancer

Interventions

DRUG

Ipatasertib

Ipatasertib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 28 days)

DRUG

Cobimetinib

Cobimetinib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length=28 days)

DRUG

Trastuzumab Emtansine

Trastuzumab Emtansine will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)

DRUG

Atezolizumab

Atezolizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)

DRUG

Bevacizumab

Bevacizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)

DRUG

Paclitaxel

Paclitaxel will be administered intravenously on Days 1, 8, and 15 of each cycle. (Cycle length=28 days)

DRUG

Giredestrant

Giredestrant will be administered by mouth once a day on Days 1-28 of each cycle (Cycle length=28 days)

DRUG

Abemaciclib

Abemaciclib will be administered by mouth twice a day during each 28-day cycle

DRUG

Inavolisib

Inavolisib will be administered by mouth once a day on Days 1-28 of each 28-day cycle

DRUG

Palbociclib

Palbociclib will be administered by mouth once a day on Days 1-21 of each 28-day cycle

DRUG

Letrozole

Letrozole will be administered by mouth once a day on Days 1-28 of each 28-day cycle

DRUG

Olaparib

Olaparib will be administered by mouth twice a day on Days 1-28 of each 28-day cycle

DRUG

Luteinizing Hormone-Releasing Hormone (LHRH) Agonists

LHRH agonists are required beginning at least 2 weeks prior to initiation of study treatment for premenopausal or perimenopausal women. Acceptable agents include goserelin or leuprolide; triptorelin is also acceptable. Monthly injections of LHRH agonist are preferred.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 21 days)

DRUG

Inavolisib

Inavolisib will be administered by mouth once a day on Days 1-21 of each 21-day cycle

Sponsors & Collaborators

• GOG Foundation

  collaborator NETWORK

• European Network of Gynaecological Oncological Trial Groups (ENGOT)

  collaborator OTHER

• Hoffmann-La Roche

  lead INDUSTRY

Principal Investigators

• Clinical Trials · Hoffmann-La Roche

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-07

Primary Completion

2028-02-28

Completion

2028-05-30

FDA Drug

Yes

Countries

• United States
• Australia
• Canada
• Czechia
• France
• Germany
• Italy
• Russia
• South Korea
• Spain
• Switzerland
• Turkey (Türkiye)
• United Kingdom

Study Locations