NCT02898207

Olaparib and Onalespib in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery or Recurrent Ovarian, Fallopian Tube, Primary Peritoneal, or Triple-Negative Breast Cancer

A Phase 1 Study of PARP Inhibitor Olaparib and HSP90 Inhibitor AT13387 for Treatment of Advanced Solid Tumors With Expansion in Patients With Recurrent Epithelial Ovarian, Fallopian Tube, Peritoneal Cancer or Recurrent Triple-Negative Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of olaparib and onalespib when given together in treating patients with solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable) or ovarian, fallopian tube, primary peritoneal, or triple-negative breast cancer that has come back (recurrent). Olaparib and onalespib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVE: I. To establish the maximum tolerated dose (MTDs) of olaparib and onalespib (AT13387) administered in combination in patients with advanced solid tumors. SECONDARY OBJECTIVES: I. To identify the dose-limiting toxicity (DLT) and other toxicities associated with olaparib and AT13387 administered in combination as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. II. To determine the recommended phase 2 doses (RP2D) of the combination of olaparib and AT13387. III. To determine the plasma pharmacokinetics of olaparib and AT13387. IV. To document anti-tumor activity of the combination of olaparib and AT13387 as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and progression free survival (PFS). Although the clinical benefit of \[this/these\] drug(s) has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. OUTLINE: This is a dose-escalation study. Patients receive olaparib orally (PO) twice daily (BID) on days 1-7 (cycle 0). Beginning in cycle 1, patients receive olaparib PO BID on days 1-28 and onalespib intravenously (IV) over 1 hour on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and every 3 months for up to 2 years.

Conditions

• Metastatic High Grade Fallopian Tube Serous Adenocarcinoma
• Metastatic Malignant Solid Neoplasm
• Metastatic Primary Peritoneal Serous Adenocarcinoma
• Metastatic Triple-Negative Breast Carcinoma
• Platinum-Resistant Fallopian Tube Carcinoma
• Platinum-Resistant Ovarian Carcinoma
• Platinum-Resistant Primary Peritoneal Carcinoma
• Recurrent Breast Carcinoma
• Recurrent High Grade Fallopian Tube Serous Adenocarcinoma
• Recurrent High Grade Ovarian Serous Adenocarcinoma
• Recurrent Primary Peritoneal High Grade Serous Adenocarcinoma
• Recurrent Triple-Negative Breast Carcinoma
• Refractory Fallopian Tube Serous Adenocarcinoma
• Refractory Ovarian Serous Adenocarcinoma
• Refractory Primary Peritoneal Serous Adenocarcinoma
• Refractory Triple-Negative Breast Carcinoma
• Unresectable High Grade Fallopian Tube Serous Adenocarcinoma
• Unresectable Malignant Solid Neoplasm
• Unresectable Primary Peritoneal Serous Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Olaparib	Given PO
DRUG	Onalespib	Given IV

Timeline

• Start date: 2017-05-19
• Primary completion: 2020-07-29
• Completion: 2022-01-14
• First posted: 2016-09-13
• Last updated: 2023-04-26
• Results posted: 2023-04-26

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study