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NCT02279433 · ClinicalTrials.gov registry record · Phase 1
A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b
A Phase 1 study of Solid Tumors, sponsored by Nuvation Bio.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
- 6
- Study locations
NCT02279433 is a Phase 1 study of Solid Tumors that has completed, run by Nuvation Bio. The registered enrollment target is 46 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (84% lower). The trial reports 6 study locations across 5 states.
The verdict
NCT02279433, a Phase 1 study of Solid Tumors, has completed, sponsored by Nuvation Bio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
- 6
- Study locations
Study Summary
DS-6051b is an orally administered inhibitor of the tyrosine kinases (ROS1) and neurotropic tyrosine kinase receptors (NTRK). This phase 1 first-in-human study evaluates safety and tolerability of DS-6051b in cancer subjects and identify a recommended phase 2 dose (RP2D). In addition, this study will also assess the pharmacokinetic (PK)/pharmacodynamic (PD) profiles and preliminary efficacy of DS-6051b.
Conditions Studied
Interventions
- DRUG DS6051b
Study Locations (6)
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Inst. - Boston
Arizona
- HonorHealth Research Institute - Scottsdale
California
- Chao Family Comprehensive Cancer Center of - Orange
New York
- New York University - New York
Texas
- South Texas Accelerated Research Therapeutics - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2014-09 |
| Est. Completion | 2019-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02279433
The ClinicalTrials.gov registry entry for NCT02279433 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (84% lower). The listed sponsor is Nuvation Bio, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which DS6051b is the first listed.
NCT02279433 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Massachusetts, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT02279433 about?
NCT02279433 is a clinical study titled "A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b". DS-6051b is an orally administered inhibitor of the tyrosine kinases (ROS1) and neurotropic tyrosine kinase receptors (NTRK). This phase 1 first-in-human study evaluates safety and tolerability of DS-6051b in cancer subjects and identify a recommended phase 2 dose (RP2D). In addition, this study wil...
What is the current status of trial NCT02279433?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2014-09. Estimated completion is 2019-03.
What conditions does trial NCT02279433 study?
This clinical trial studies the following conditions: Solid Tumors.
What interventions are being tested in trial NCT02279433?
The interventions under investigation include: DS6051b (DRUG).
Who is sponsoring clinical trial NCT02279433?
This trial is sponsored by Nuvation Bio, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02279433 being conducted?
This trial has 6 study locations across Arizona, California, Massachusetts, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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