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NCT03510455 · ClinicalTrials.gov registry record · Phase 2
BGJ398 for the Treatment of Tumor-Induced Osteomalacia
A Phase 2 study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT03510455: Clinical Trial Phase 2 study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
NCT03510455 is a Phase 2 study that was terminated before completion, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03510455, a Phase 2 study, was terminated before completion, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
Background: People with tumor-induced osteomalacia (TIO) have small tumors that may cause low blood phosphorus, weak muscles, bone pain, and broken bones. The tumors may be so small they are hard to find or impossible to remove. Researchers want to test a drug that may help treat TIO. Objective: To see how the drug BGJ398 affects people with tumor-induced osteomalacia. Eligibility: People ages 18-85 who are in NIH protocol 01-D-0184 and have TIO that cannot be found or easily removed Design: At every study visit, participants will have: * Medical history * Physical exam * Blood and urine tests * Questions about their health and fatigue At the screening visit, participants will also have a heart and eye tests. They may have other tests to find their tumor. The baseline visit will be a 1-week stay in the clinic. Participants will have the regular study tests, plus: * Their first dose of the study drug capsules * Blood and urine collected every 2-4 hours for 24 hours. A thin plastic tube will be inserted in a vein to collect blood. * Heart and kidney ultrasounds * Activities that test strength * 6-minute walk test Participants will take the study drug for six 1-month cycles. In each cycle, participants will: * Take the study drug every day for 4 weeks. * Have 1 visit. Participants will collect their urine for 24 hours and have their blood drawn. Participants will have the regular study tests and repeat some baseline tests. * Have blood and urine tests at their local lab. Participants will have 1 visit at the end of the last cycle and another 3 months later....
Primary Outcome
Participants were monitored for up to 12 weeks after stopping BGJ398. A participant was considered to have a complete metabolic remission by achieving both normal blood FGF23 and phosphorus levels in the blood for 12 weeks after stopping BGJ398.
Interventions
- DRUG BGJ398
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2019-02-27 |
| Est. Completion | 2020-05-04 |
| Phase | Phase 2 |
Why NCT03510455 stopped before completion
NCT03510455 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which BGJ398 is the first listed.
NCT03510455 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03510455 about?
NCT03510455 is a clinical study titled "BGJ398 for the Treatment of Tumor-Induced Osteomalacia". Background: People with tumor-induced osteomalacia (TIO) have small tumors that may cause low blood phosphorus, weak muscles, bone pain, and broken bones. The tumors may be so small they are hard to find or impossible to remove. Researchers want to test a drug that may help treat TIO. Objective: ...
What is the current status of trial NCT03510455?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2019-02-27. Estimated completion is 2020-05-04.
What interventions are being tested in trial NCT03510455?
The interventions under investigation include: BGJ398 (DRUG).
Who is sponsoring clinical trial NCT03510455?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03510455's enrollment target sits among peer trials
4 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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