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NCT02757326 · ClinicalTrials.gov registry record · Phase 1
ABC294640 (Opaganib) in Refractory / Relapsed Multiple Myeloma
A Phase 1 study, sponsored by RedHill Biopharma Limited.
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT02757326 is a Phase 1 study that was terminated before completion, run by RedHill Biopharma Limited. The registered enrollment target is 13 participants.
The verdict
NCT02757326, a Phase 1 study, was terminated before completion, sponsored by RedHill Biopharma Limited.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This is a Phase Ib/II safety and efficacy trial of single agent ABC294640, an inhibitor of sphingosine kinase 2 and dihydroceramide desaturase, in refractory or relapsed multiple myeloma (MM). Cohorts of patients with refractory or relapsed MM who have previously been treated with proteasome inhibitors and immunomodulatory agents will receive increasing doses of oral ABC294640. The starting dosage for ABC294640 will be 250 mg bis in die (BID) which is known to be safely tolerated as a single agent, and the ABC294640 dose will be escalated to two additional dose cohorts of 500 and 750 mg BID using Bayesian model average continual reassessment method (BMA-CRM) for dose finding. It is expected that 18 patients will be used to determine the maximum tolerated dose (MTD) for ABC294640 in refractory or relapsed MM. Up to 56 additional patients will be treated on the phase II portion of the study at the MTD or maximum dose used in phase I, with interim stopping rules for futility. Pharmacokinetic (PK) and pharmacodynamic (PD) assessments of ABC294640 will be conducted on Day 1 of Cycle 1. Bone marrow biopsy will be obtained prior to the initiation of ABC294640, at the end of cycle #3 and at the end of cycle #6. In addition to serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP) and serum free light chain measurement, correlative studies will be performed to measure sphingosine kinase 2 (SK2) activity, sphingosine metabolites, and additional biomarkers in CD138+ myeloma cells.
Interventions
- DRUG Opaganib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2016-12-13 |
| Est. Completion | 2019-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02757326
The ClinicalTrials.gov registry entry for NCT02757326 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is RedHill Biopharma Limited, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Opaganib is the first listed.
NCT02757326 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02757326 about?
NCT02757326 is a clinical study titled "ABC294640 (Opaganib) in Refractory / Relapsed Multiple Myeloma". This is a Phase Ib/II safety and efficacy trial of single agent ABC294640, an inhibitor of sphingosine kinase 2 and dihydroceramide desaturase, in refractory or relapsed multiple myeloma (MM). Cohorts of patients with refractory or relapsed MM who have previously been treated with proteasome inhibit...
What is the current status of trial NCT02757326?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2016-12-13. Estimated completion is 2019-05.
What interventions are being tested in trial NCT02757326?
The interventions under investigation include: Opaganib (DRUG).
Who is sponsoring clinical trial NCT02757326?
This trial is sponsored by RedHill Biopharma Limited, which has 13 total clinical trials registered on ClinicalTrials.gov.
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