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ACY-1215 + Nab-paclitaxel in Metastatic Breast Cancer

NCT02632071 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-01-07

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Acetylon Pharmaceuticals Incorporated

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Kevin Kalinsky, MD, MS · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2020-09-30
Completion
2020-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02632071 on ClinicalTrials.gov