drugset / Trial / NCT02632071

ACY-1215 + Nab-paclitaxel in Metastatic Breast Cancer

NCT02632071

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2016-03-01
Primary completion
2020-09-30
Completion
2020-09-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Paclitaxel Small molecule 100 mg/m2 Intravenous
Comparator Ricolinostat Small molecule 80 mg Oral
Comparator Ricolinostat Small molecule 120 mg Oral
Comparator Ricolinostat Small molecule 180 mg Oral
Comparator Ricolinostat Small molecule 240 mg Oral

Indications