drugset / Trial / NCT02632071
ACY-1215 + Nab-paclitaxel in Metastatic Breast Cancer
Phase 1
Completed
17 enrolled
Columbia University
Acetylon Pharmaceuticals Incorporated · collabNational Cancer Institute (NCI) · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |