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NCT02270788 · ClinicalTrials.gov registry record · Phase 1
Crenolanib in Combination With Sorafenib in Patients With Refractory or Relapsed Hematologic Malignancies
A Phase 1 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT02270788 is a Phase 1 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 10 participants.
The verdict
NCT02270788, a Phase 1 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
PRIMARY OBJECTIVE: This is a pilot study to characterize the toxicity profile, to determine the maximum tolerated dose of the combination of crenolanib and sorafenib, and to determine the feasibility of administering these drugs in patients with relapsed or refractory hematologic malignancies, including acute myeloid leukemia (AML), AML with prior myelodysplastic syndrome (MDS), and myeloperoxidase (MPO)-positive mixed phenotype acute leukemia with FLT3-internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations. The study will include two phases: * The dose-escalation phase will characterize the dose-limiting toxicities (DLTs) and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of crenolanib when given in combination with sorafenib. * The dose-expansion cohort will further assess the safety and explore the efficacy of this combination.
Interventions
- DRUG Sorafenib
- DRUG Crenolanib
- DRUG methotrexate, hydrocortisone and cytarabine with leucovorin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-04-02 |
| Est. Completion | 2016-10-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02270788
The ClinicalTrials.gov registry entry for NCT02270788 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 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 3 interventions - of which Sorafenib is the first listed.
NCT02270788 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02270788 about?
NCT02270788 is a clinical study titled "Crenolanib in Combination With Sorafenib in Patients With Refractory or Relapsed Hematologic Malignancies". PRIMARY OBJECTIVE: This is a pilot study to characterize the toxicity profile, to determine the maximum tolerated dose of the combination of crenolanib and sorafenib, and to determine the feasibility of administering these drugs in patients with relapsed or refractory hematologic malignancies, incl...
What is the current status of trial NCT02270788?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2015-04-02. Estimated completion is 2016-10-17.
What interventions are being tested in trial NCT02270788?
The interventions under investigation include: Sorafenib (DRUG), Crenolanib (DRUG), methotrexate, hydrocortisone and cytarabine with leucovorin (DRUG).
Who is sponsoring clinical trial NCT02270788?
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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