NCT02632071

ACY-1215 + Nab-paclitaxel in Metastatic Breast Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Breast Cancer
• Breast Carcinoma

Interventions

Type	Name	Description
DRUG	ACY-1215	An orally active, selective HDAC6 inhibitor. Assigned dosing 80 mg, 120 mg, 180 mg, 240 mg PO, once daily Days 1-21 in a 28-day cycle
DRUG	Nab-paclitaxel	Taxanes are among the most widely used chemotherapy agents in the treatment of breast cancer. 100 mg/m2 30 minute IV infusion Days 1, 8, and 15 in a 28-day cycle

Timeline

• Start date: 2016-03-01
• Primary completion: 2020-09-30
• Completion: 2020-09-30
• First posted: 2015-12-16
• Last updated: 2021-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study