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NCT03590054 · ClinicalTrials.gov registry record · Phase 1
Abexinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumor Malignancies
A Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Melanoma, sponsored by Rahul Aggarwal.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT03590054: Completed Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Melanoma, sponsored by Rahul Aggarwal.
NCT03590054 is a Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Melanoma that has completed, run by Rahul Aggarwal. The registered enrollment target is 35 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03590054, a Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Melanoma, has completed, sponsored by Rahul Aggarwal.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the best dose and side effects of abexinostat and how well it works with given together with pembrolizumab in treating participants with microsatellite instability (MSI) solid tumors that have spread to other places in the body. Abexinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving abexinostat and pembrolizumab may work better in treating participants with solid tumors.
Primary Outcome
Starting at dose level 1, if 2/3 patients have a dose-limiting toxicity (DLT), the dose will be de-escalated to dose -1. If 0/3 patients experience a DLT, 3 patients will be treated at the next dose level. If DLT attributable to the treatment is experienced in 1/3 patients, three more patients (for a total of six patients) will be treated at that dose level. If no additional DLTs are observed at the expanded dose level (i.e. 1/6 with DLT), the dose will be escalated. Escalation will terminate as
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Abexinostat
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2018-08-20 |
| Est. Completion | 2023-11-30 |
| Phase | Phase 1 |
What the finished NCT03590054 record still lists
NCT03590054 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (83% lower).
The record links to 10 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03590054 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03590054 about?
NCT03590054 is a clinical study titled "Abexinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumor Malignancies". This phase I trial studies the best dose and side effects of abexinostat and how well it works with given together with pembrolizumab in treating participants with microsatellite instability (MSI) solid tumors that have spread to other places in the body. Abexinostat may stop the growth of tumor cel...
What is the current status of trial NCT03590054?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2018-08-20. Estimated completion is 2023-11-30.
What conditions does trial NCT03590054 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Metastatic Melanoma, Non-Small-Cell Lung Carcinoma, Metastatic Urothelial Carcinoma, Metastatic Head-and-neck Squamous-cell Carcinoma.
What interventions are being tested in trial NCT03590054?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Abexinostat (DRUG).
Who is sponsoring clinical trial NCT03590054?
This trial is sponsored by Rahul Aggarwal, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03590054 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03590054's enrollment target sits among peer trials
35 75th of 92 higher than 17 of 92 other Metastatic Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Solid Neoplasm 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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