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NCT03834961 · ClinicalTrials.gov registry record · Phase 2
Larotrectinib in Treating Patients With Previously Untreated TRK Fusion Solid Tumors and TRK Fusion Relapsed Acute Leukemia
A Phase 2 study of Solid Neoplasm and Central Nervous System Neoplasm, sponsored by Children's Oncology Group.
- Active
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
- 20
- Study locations
NCT03834961 is a Phase 2 study of Solid Neoplasm and Central Nervous System Neoplasm that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 33 participants, below the 940-participant average among 12 other Solid Neoplasm trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT03834961, a Phase 2 study of Solid Neoplasm and Central Nervous System Neoplasm, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies the side effects and how well larotrectinib works in treating patients with previously untreated TRK fusion solid tumors and TRK fusion acute leukemia that has come back. Larotrectinib may stop the growth of cancer cells with TRK fusions by blocking the TRK enzymes needed for cell growth.
Conditions Studied
Interventions
- DRUG Larotrectinib Sulfate
Study Locations (20)
Florida
- Broward Health Medical Center - Fort Lauderdale
- Golisano Children's Hospital of Southwest Florida - Fort Myers
- University of Florida Health Science Center - Gainesville - Gainesville
- Nemours Children's Clinic-Jacksonville - Jacksonville
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- Nicklaus Children's Hospital - Miami
- Nemours Children's Hospital - Orlando
California
- Kaiser Permanente Downey Medical Center - Downey
- Children's Hospital Los Angeles - Los Angeles
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- UCSF Medical Center-Mission Bay - San Francisco
Colorado
- Children's Hospital Colorado - Aurora
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center - Denver
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
- Children's National Medical Center - Washington D.C.
Alabama
- Children's Hospital of Alabama - Birmingham
Arkansas
- Arkansas Children's Hospital - Little Rock
Connecticut
- Yale University - New Haven
Delaware
- Alfred I duPont Hospital for Children - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2019-10-25 |
| Est. Completion | 2027-07-25 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03834961
The ClinicalTrials.gov registry entry for NCT03834961 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 940-participant average among 12 other Solid Neoplasm trials with a reported enrollment target (96% lower). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Solid Neoplasm appearing as the primary indexed condition, and to 1 intervention - of which Larotrectinib Sulfate is the first listed.
NCT03834961 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT03834961 about?
NCT03834961 is a clinical study titled "Larotrectinib in Treating Patients With Previously Untreated TRK Fusion Solid Tumors and TRK Fusion Relapsed Acute Leukemia". This phase II trial studies the side effects and how well larotrectinib works in treating patients with previously untreated TRK fusion solid tumors and TRK fusion acute leukemia that has come back. Larotrectinib may stop the growth of cancer cells with TRK fusions by blocking the TRK enzymes needed...
What is the current status of trial NCT03834961?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2019-10-25. Estimated completion is 2027-07-25.
What conditions does trial NCT03834961 study?
This clinical trial studies the following conditions: Solid Neoplasm, Central Nervous System Neoplasm, Refractory Acute Leukemia, Infantile Fibrosarcoma, Recurrent Acute Leukemia.
What interventions are being tested in trial NCT03834961?
The interventions under investigation include: Larotrectinib Sulfate (DRUG).
Who is sponsoring clinical trial NCT03834961?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03834961 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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