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NCT02503423 · ClinicalTrials.gov registry record · Phase 1
Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas
A Phase 1 study of Lymphoma and Solid Tumors, sponsored by Taiho Oncology.
- Active
- Registry status
- Phase 1
- Development phase
- 253
- Enrollment target
- 20
- Study locations
NCT02503423: Active Phase 1 study of Lymphoma and Solid Tumors, sponsored by Taiho Oncology.
NCT02503423 is a Phase 1 study of Lymphoma and Solid Tumors that is active but no longer recruiting, run by Taiho Oncology. The registered enrollment target is 253 participants, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02503423, a Phase 1 study of Lymphoma and Solid Tumors, is active but no longer recruiting, sponsored by Taiho Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 253 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label, dose-escalation Phase 1/2 study to assess the safety of ASTX660, determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing regimen, and to obtain preliminary efficacy, pharmacokinetic (PK), and target engagement data, in subjects with advanced solid tumors or lymphoma for whom standard life-prolonging measures are not available.
Primary Outcome
Incidence of dose-limiting toxicities (DLTs) and other adverse events (AEs)
Conditions Studied
Interventions
- DRUG ASTX660
Study Locations (20)
New York
- Roswell Park Cancer Institute - Buffalo
- New York University Langone Medical Center - New York
- New York Presbyterian Hospital Columbia University Medical Center - New York
- Icahn School of Medicine at Mount Sinai - New York
- Rochester Skin Lymphoma Medical Group - Rochester
California
- USC/Norris Comprehensive Cancer Center - Los Angeles
- Cedars-Sinai Medical Center - Los Angeles
- UC Davis Medical Center - Sacramento
Massachusetts
- Tufts Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- HonorHealth Research Institute - Scottsdale
Connecticut
- Simlow Cancer Hospital at Yale - New Haven
Georgia
- Emory University winship Cancer Institute - Atlanta
Illinois
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 253 participants |
| Start Date | 2015-07-14 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What the registry record for NCT02503423 still lists
NCT02503423 is an interventional study that assigns participants to a tested intervention. The registered 253 participants enrollment target is mid-sized for trials with a published cap, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (48% lower).
The record links to 2 conditions, with Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which ASTX660 is the first listed.
NCT02503423 names 20 study sites across 13 states, led by New York, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02503423 about?
NCT02503423 is a clinical study titled "Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas". This is an open-label, dose-escalation Phase 1/2 study to assess the safety of ASTX660, determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing regimen, and to obtain preliminary efficacy, pharmacokinetic (PK), and target engagement data, in subjects with ...
What is the current status of trial NCT02503423?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 253 participants. The study started on 2015-07-14. Estimated completion is 2027-12.
What conditions does trial NCT02503423 study?
This clinical trial studies the following conditions: Lymphoma, Solid Tumors.
What interventions are being tested in trial NCT02503423?
The interventions under investigation include: ASTX660 (DRUG).
Who is sponsoring clinical trial NCT02503423?
This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02503423 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02503423's enrollment target sits among peer trials
253 42nd of 299 higher than 258 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
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