mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian
NCT02208375 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 159
Last updated 2025-12-31
Summary
This phase Ib/II trial studies the side effects and best dose of olaparib and vistusertib (AZD2014) or olaparib and capivasertib (AZD5363) when given together in treating patients with endometrial, triple negative breast cancer, ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent). Olaparib, vistusertib, and capivasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Conditions
- BRCA1 Mutation Carrier
- BRCA2 Mutation Carrier
- Endometrial Adenocarcinoma
- Estrogen Receptor Negative
- HER2/Neu Negative
- High Grade Ovarian Serous Adenocarcinoma
- Progesterone Receptor Negative
- Recurrent Breast Carcinoma
- Recurrent Fallopian Tube Carcinoma
- Recurrent Ovarian Carcinoma
- Recurrent Primary Peritoneal Carcinoma
- Recurrent Uterine Corpus Carcinoma
- Stage III Uterine Corpus Cancer AJCC v7
- Stage IV Breast Cancer AJCC v6 and v7
- Stage IV Uterine Corpus Cancer AJCC v7
- Triple-Negative Breast Carcinoma
Interventions
- DRUG
-
Vistusertib
Given PO
- DRUG
-
Capivasertib
Given PO
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- DRUG
-
Given PO
- OTHER
-
Pharmacological Study
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Shannon N Westin · M.D. Anderson Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-11-11
- Primary Completion
- 2026-06-30
- Completion
- 2026-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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