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NCT01644773 · ClinicalTrials.gov registry record · Phase 1
Study of the Combination of Crizotinib and Dasatinib in Pediatric Research Participants With Diffuse Pontine Glioma (DIPG) and High-Grade Glioma (HGG)
A Phase 1 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT01644773 is a Phase 1 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 36 participants.
The verdict
NCT01644773, a Phase 1 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
This is a phase I study to find the highest tolerable dose of crizotinib and dasatinib given in combination to patients with diffuse intrinsic pontine glioma (DIPG) and other types of high grade gliomas (HGG). Participants will receive escalating doses until the highest dose is determined. Participants will be enrolled in two strata: stratum A for recurrent/ progressive tumors and stratum B for recently diagnosed patients who have completed standard radiation therapy without progressive disease. Up to 7 dosage levels will be tested. Both drugs are taken orally daily, once per day. Correlative pharmacokinetic and biology studies are planned, as well as advanced methods of magnetic resonance imaging (MRI).
Interventions
- DRUG Dasatinib
- DRUG Crizotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2012-11-27 |
| Est. Completion | 2018-09-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01644773
The ClinicalTrials.gov registry entry for NCT01644773 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dasatinib is the first listed.
NCT01644773 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01644773 about?
NCT01644773 is a clinical study titled "Study of the Combination of Crizotinib and Dasatinib in Pediatric Research Participants With Diffuse Pontine Glioma (DIPG) and High-Grade Glioma (HGG)". This is a phase I study to find the highest tolerable dose of crizotinib and dasatinib given in combination to patients with diffuse intrinsic pontine glioma (DIPG) and other types of high grade gliomas (HGG). Participants will receive escalating doses until the highest dose is determined. Participa...
What is the current status of trial NCT01644773?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2012-11-27. Estimated completion is 2018-09-28.
What interventions are being tested in trial NCT01644773?
The interventions under investigation include: Dasatinib (DRUG), Crizotinib (DRUG).
Who is sponsoring clinical trial NCT01644773?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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