Spots Global Cancer Trial Database for Onalespib and Paclitaxel in Treating Patients With Advanced Triple Negative Breast Cancer

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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