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Spots Global Cancer Trial Database for ACY-1215 + Nab-paclitaxel in Metastatic Breast Cancer

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Trial Identification

Brief Title: ACY-1215 + Nab-paclitaxel in Metastatic Breast Cancer

Official Title: Multi-center Phase IB Trial of ACY-1215 (Ricolinostat) Combined With Nab-paclitaxel in Unresectable or Metastatic Breast Cancer

Study ID: NCT02632071

Study Description

Brief Summary: This is a non-randomized phase 1 trial designed to determine the MTD and evaluate the safety and tolerability of ACY-1215 with nab-paclitaxel. Based on the activity profile of ACY-1215 in breast cancer, corresponding biomarker availability with the HDAC6 MR score, and its potential synergy with taxanes, these data support the rationale for testing the ability of ACY-1215 to improve the response rate for patients with metastatic breast cancer in combination with standard taxane chemotherapy.

Detailed Description: Breast cancer is the most common female cancer and the second most common cause of death in women. Women with hormone receptor-negative tumors that are associated with symptomatic visceral metastases, or hormone receptor-positive tumors that are refractory to endocrine therapy require cytotoxic chemotherapy for disease control. The standard of care for patients with metastatic breast cancer includes single agent taxane-based chemotherapy. Combination chemotherapy generally provides higher rates of objective response and longer time to progression, compared to single-agent chemotherapy. However, it is associated with increased toxicity and is of little survival benefit. There remains an unmet need for combination regimens incorporating new, effective and oftentimes less toxic targeted agents together with standard chemotherapy.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Columbia Irving University Medical Center, New York, New York, United States

Contact Details

Name: Kevin Kalinsky, MD, MS

Affiliation: Columbia University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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