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NCT04195555 · ClinicalTrials.gov registry record · Phase 2
Ivosidenib in Treating Patients With Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With IDH1 Mutations (A Pediatric MATCH Treatment Trial)
A Phase 2 study of Recurrent Malignant Solid Neoplasm and Recurrent Malignant Glioma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
- 20
- Study locations
NCT04195555: Active Phase 2 study of Recurrent Malignant Solid Neoplasm and Recurrent Malignant Glioma, sponsored by National Cancer Institute (NCI).
NCT04195555 is a Phase 2 study of Recurrent Malignant Solid Neoplasm and Recurrent Malignant Glioma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 3 participants, below the 300-participant average among 37 other Recurrent Malignant Solid Neoplasm trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04195555, a Phase 2 study of Recurrent Malignant Solid Neoplasm and Recurrent Malignant Glioma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II Pediatric MATCH trial studies how well ivosidenib works in treating patients with solid tumors, including central nervous system tumors, lymphomas and histiocytic disorders that have not responded to (refractory) or have come back after (recurrent) prior treatment that have IDH (isocitrate dehydrogenase) 1 genetic alterations (mutations). Ivosidenib may block the growth of cancer cells that have specific genetic changes in an important signaling pathway called the IDH pathway.
Primary Outcome
A responder is defined as a patient who achieves a best response of partial response or complete response on the study. Response rates will be calculated as the percent of evaluable patients who are responders. The revised Response Evaluation Criteria in Solid Tumors guideline (version 1.1) was used to determine response and progression in this study, with specific criteria outlined for the different subtypes of tumors (e.g., 2-dimensional measurements for central nervous system tumors).
Conditions Studied
Interventions
- DRUG Ivosidenib
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- City of Hope Comprehensive Cancer Center - Duarte
- Loma Linda University Medical Center - Loma Linda
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Mattel Children's Hospital UCLA - Los Angeles
- Valley Children's Hospital - Madera
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- University of California Davis Comprehensive Cancer Center - Sacramento
- Rady Children's Hospital - San Diego - San Diego
Arizona
- Banner Children's at Desert - Mesa
- Phoenix Childrens Hospital - Phoenix
- Banner University Medical Center - Tucson - Tucson
Alabama
- Children's Hospital of Alabama - Birmingham
Alaska
- Providence Alaska Medical Center - Anchorage
Arkansas
- Arkansas Children's Hospital - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2020-07-20 |
| Est. Completion | 2026-05-09 |
| Phase | Phase 2 |
What the registry record for NCT04195555 still lists
NCT04195555 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 300-participant average among 37 other Recurrent Malignant Solid Neoplasm trials with a reported enrollment target (99% lower).
The record links to 10 conditions, with Recurrent Malignant Solid Neoplasm appearing as the primary indexed condition, and to 1 intervention - of which Ivosidenib is the first listed.
NCT04195555 names 20 study sites across 5 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT04195555 about?
NCT04195555 is a clinical study titled "Ivosidenib in Treating Patients With Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With IDH1 Mutations (A Pediatric MATCH Treatment Trial)". This phase II Pediatric MATCH trial studies how well ivosidenib works in treating patients with solid tumors, including central nervous system tumors, lymphomas and histiocytic disorders that have not responded to (refractory) or have come back after (recurrent) prior treatment that have IDH (isocit...
What is the current status of trial NCT04195555?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2020-07-20. Estimated completion is 2026-05-09.
What conditions does trial NCT04195555 study?
This clinical trial studies the following conditions: Recurrent Malignant Solid Neoplasm, Recurrent Malignant Glioma, Recurrent Medulloblastoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Ewing Sarcoma.
What interventions are being tested in trial NCT04195555?
The interventions under investigation include: Ivosidenib (DRUG).
Who is sponsoring clinical trial NCT04195555?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04195555 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Malignant Solid Neoplasm
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 NCT04195555's enrollment target sits among peer trials
3 37th of 37 higher than 1 of 37 other Recurrent Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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