NCT02474173

Onalespib and Paclitaxel in Treating Patients With Advanced Triple Negative Breast Cancer

Phase 1b Study of HSP90 Inhibitor, AT13387 (Onalespib) in Combination With Paclitaxel in Patients With Advanced, Triple Negative Breast Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase Ib trial studies the side effects and best dose onalespib when given together with paclitaxel in treating patients with triple negative breast cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Onalespib works by blocking proper processing of proteins that are important for cancer growth. This results in inability of these proteins to work properly. Paclitaxel kills breast cancer cells by interfering with their ability to divide. Giving onalespib together with paclitaxel may be better than giving either one alone in treating patients with breast cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the recommended phase 2 dose (RP2D) of onalespib (AT13387) in combination with paclitaxel in patients with advanced triple negative breast cancer (TNBC). II. To determine the toxicity profile (based on Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v.\]5.0) of the combination of AT13387 in combination with paclitaxel in patients with advanced TNBC. SECONDARY OBJECTIVES: I. To determine the effect of AT13387 on pharmacokinetics of paclitaxel in the study patient population. II. To determine the effect of paclitaxel on pharmacokinetics of AT13387 in the study patient population. III. To observe anti-tumor activity determining the overall response rate (partial response + complete response), response duration and progression-free survival. OUTLINE: This is a dose-escalation study of onalespib. SAFETY RUN-IN: Patients receive onalespib intravenously (IV) over 1 hour on day -7. TREATMENT: Patients receive paclitaxel IV over 60 minutes on day 1, 8, and 15. Patients also receive onalespib IV over 1 hour beginning on days 8 and 15 of cycle 1 and on days 1, 8, and 15 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months.

Conditions

• Advanced Breast Carcinoma
• Metastatic Breast Carcinoma
• Stage III Breast Cancer AJCC v7
• Stage IIIA Breast Cancer AJCC v7
• Stage IIIB Breast Cancer AJCC v7
• Stage IIIC Breast Cancer AJCC v7
• Stage IV Breast Cancer AJCC v6 and v7
• Triple-Negative Breast Carcinoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Onalespib	Given IV
DRUG	Paclitaxel	Given IV
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2016-01-15
• Primary completion: 2022-10-26
• Completion: 2022-10-26
• First posted: 2015-06-17
• Last updated: 2022-11-04

Locations

4 sites across 1 country: United States