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NCT04145349 · ClinicalTrials.gov registry record · Phase 1
CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor
A Phase 1 study of Desmoplastic Small Round Cell Tumor, sponsored by Eli Lilly and Company.
- Active
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 20
- Study locations
NCT04145349: Active Phase 1 study of Desmoplastic Small Round Cell Tumor, sponsored by Eli Lilly and Company.
NCT04145349 is a Phase 1 study of Desmoplastic Small Round Cell Tumor that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 30 participants, below the 70-participant average among 7 other Desmoplastic Small Round Cell Tumor trials with a reported enrollment target (57% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04145349, a Phase 1 study of Desmoplastic Small Round Cell Tumor, is active but no longer recruiting, sponsored by Eli Lilly and Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is being conducted to test the safety and efficacy of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory desmoplastic small round cell tumor (DSRCT) in children and young adults. This trial is part of the CAMPFIRE master protocol (NCT05999994) which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer. Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.
Primary Outcome
PFS was defined as the time from randomization to the date of investigator-determined objective progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause in the absence of disease progression. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesion
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Ramucirumab
- DRUG Vinorelbine
Study Locations (20)
Other
- Universitaetsklinikum Hamburg-Eppendorf - Hamburg
- Kyushu University Hospital - Fukuoka
- Hospital Universitario Virgen Del Rocio - Seville
Arizona
- Phoenix Children's Hospital - Phoenix
California
- Children's Hospital of Los Angeles - Los Angeles
District of Columbia
- Children's National Medical Center - Washington D.C.
Missouri
- Washington University - St Louis
New York
- Memorial Sloan Kettering Cancer Center - New York
Pennsylvania
- Children's Hospital of Philadelphia (CHOP) - Philadelphia
Victoria
- Royal Children's Hospital - Parkville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-01-22 |
| Est. Completion | 2026-10 |
| Phase | Phase 1 |
What the registry record for NCT04145349 still lists
NCT04145349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 70-participant average among 7 other Desmoplastic Small Round Cell Tumor trials with a reported enrollment target (57% lower).
The record links to 1 condition, with Desmoplastic Small Round Cell Tumor appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT04145349 names 20 study sites across 18 states, led by Other, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT04145349 about?
NCT04145349 is a clinical study titled "CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor". This study is being conducted to test the safety and efficacy of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory desmoplastic small round cell tumor (DSRCT) in children and young adults. This trial is part of the CAMPFIRE master protocol (NCT...
What is the current status of trial NCT04145349?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2020-01-22. Estimated completion is 2026-10.
What conditions does trial NCT04145349 study?
This clinical trial studies the following conditions: Desmoplastic Small Round Cell Tumor.
What interventions are being tested in trial NCT04145349?
The interventions under investigation include: Cyclophosphamide (DRUG), Ramucirumab (DRUG), Vinorelbine (DRUG).
Who is sponsoring clinical trial NCT04145349?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04145349 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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