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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: Active Phase 2 study of Solid Neoplasm and Central Nervous System Neoplasm, sponsored by Children's Oncology Group.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A responder is defined as a patient who achieves a best response of partial response (PR) or complete response (CR) on the study. Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed accounting for the two-stage design.
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 |
What the registry record for NCT03834961 still lists
NCT03834961 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 940-participant average among 12 other Solid Neoplasm trials with a reported enrollment target (96% lower).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03834961's enrollment target sits among peer trials
33 10th of 12 higher than 3 of 12 other Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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