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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: Completed Phase 1 study, sponsored by St. Jude Children's Research Hospital.
NCT02270788 is a Phase 1 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Any participant who experiences DLT at any time during cycle 1 of protocol therapy is considered evaluable for toxicity. Participants without DLT and can be followed for 28 days are also considered evaluable for toxicity. Participants who are not evaluable for toxicity (such as those removed early from therapy to start alternate therapy) at a given dose level will be replaced.
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 |
What the finished NCT02270788 record still lists
NCT02270788 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Sorafenib is the first listed.
NCT02270788 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02270788's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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