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NCT02632071 · ClinicalTrials.gov registry record · Phase 1
ACY-1215 + Nab-paclitaxel in Metastatic Breast Cancer
A Phase 1 study of Metastatic Breast Cancer and Breast Carcinoma, sponsored by Columbia University.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT02632071: Completed Phase 1 study of Metastatic Breast Cancer and Breast Carcinoma, sponsored by Columbia University.
NCT02632071 is a Phase 1 study of Metastatic Breast Cancer and Breast Carcinoma that has completed, run by Columbia University. The registered enrollment target is 17 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02632071, a Phase 1 study of Metastatic Breast Cancer and Breast Carcinoma, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The maximum tolerated dose (MTD) combination is defined as the dose combination associated with a target probability of dose limiting toxicity (DLT) of 0.25. A dose-limiting toxicity is defined as the MTD with DLTs defined as any grade 3 non-hematologic toxicities despite maximal supportive care or any grade 4 hematologic toxicity. The MTD will be estimated using the time to event continual reassessment method (TITE-CRM). The TITE-CRM will use an empirical dose-toxicity model, with a sample size
Conditions Studied
Interventions
- DRUG Nab-paclitaxel
- DRUG ACY-1215
Study Locations (1)
New York
- Columbia Irving University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2016-03-01 |
| Est. Completion | 2020-09-30 |
| Phase | Phase 1 |
What the finished NCT02632071 record still lists
NCT02632071 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Nab-paclitaxel is the first listed.
NCT02632071 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02632071 about?
NCT02632071 is a clinical study titled "ACY-1215 + Nab-paclitaxel in Metastatic Breast Cancer". 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 taxa...
What is the current status of trial NCT02632071?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2016-03-01. Estimated completion is 2020-09-30.
What conditions does trial NCT02632071 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, Breast Carcinoma.
What interventions are being tested in trial NCT02632071?
The interventions under investigation include: Nab-paclitaxel (DRUG), ACY-1215 (DRUG).
Who is sponsoring clinical trial NCT02632071?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02632071 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02632071's enrollment target sits among peer trials
17 125th of 139 higher than 15 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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