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NCT04974008 · ClinicalTrials.gov registry record · Phase 2
Osteosarcoma Maintenance Therapy With OST31-164
A Phase 2 study of Bone Cancer, sponsored by Emerald Clinical.
- Active
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
- 20
- Study locations
NCT04974008: Active Phase 2 study of Bone Cancer, sponsored by Emerald Clinical.
NCT04974008 is a Phase 2 study of Bone Cancer that is active but no longer recruiting, run by Emerald Clinical. The registered enrollment target is 39 participants, below the 723-participant average among 3 other Bone Cancer trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04974008, a Phase 2 study of Bone Cancer, is active but no longer recruiting, sponsored by Emerald Clinical.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
- 20
- Study locations
Study Summary
Up to 45 Patients aged 12 to 39 with osteosarcoma (bone cancer) that had recurred in the lungs and has recently been surgically removed will be enrolled. Patients will receive OST31-164 infusions every 3 weeks over 48 weeks and be followed after that for 3 years.
Primary Outcome
The relative proportion of patients experiencing event-free (recurrence-free) survival at 12 months, compared to historical controls. Patients will be e valuated for recurrence every 3 months, consistent with the standard of care.
Conditions Studied
Interventions
- DRUG OST31-164
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Los Angeles
- Children's Hospital of Orange County - Orange
- Rady Children's Hospital - San Diego
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- UPMC Children's Hospital of Pittsburgh - Pittsburgh
Colorado
- Children's Hospital of Colorado - Aurora
Connecticut
- Connecticut Children's - Hartford
Delaware
- Nemours/ Alfred I duPont Hospital for Children - Wilmington
Florida
- Johns Hopkins All Children's Hospital - St. Petersburg
Georgia
- Children's Healthcare of Atlanta - Atlanta
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2021-10-21 |
| Est. Completion | 2027-10-31 |
| Phase | Phase 2 |
What the registry record for NCT04974008 still lists
NCT04974008 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 723-participant average among 3 other Bone Cancer trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Bone Cancer appearing as the primary indexed condition, and to 1 intervention - of which OST31-164 is the first listed.
NCT04974008 names 20 study sites across 17 states, led by California, Pennsylvania, Colorado.
Frequently Asked Questions
What is clinical trial NCT04974008 about?
NCT04974008 is a clinical study titled "Osteosarcoma Maintenance Therapy With OST31-164". Up to 45 Patients aged 12 to 39 with osteosarcoma (bone cancer) that had recurred in the lungs and has recently been surgically removed will be enrolled. Patients will receive OST31-164 infusions every 3 weeks over 48 weeks and be followed after that for 3 years.
What is the current status of trial NCT04974008?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2021-10-21. Estimated completion is 2027-10-31.
What conditions does trial NCT04974008 study?
This clinical trial studies the following conditions: Bone Cancer.
What interventions are being tested in trial NCT04974008?
The interventions under investigation include: OST31-164 (DRUG).
Who is sponsoring clinical trial NCT04974008?
This trial is sponsored by Emerald Clinical, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04974008 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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