Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS
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ClinicalTrials.gov Identifier: NCT03564873 |
Recruitment Status :
Active, not recruiting
First Posted : June 21, 2018
Last Update Posted : May 3, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | June 8, 2018 | ||||
First Posted Date ICMJE | June 21, 2018 | ||||
Last Update Posted Date | May 3, 2024 | ||||
Actual Study Start Date ICMJE | September 17, 2018 | ||||
Estimated Primary Completion Date | December 14, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS | ||||
Official Title ICMJE | Concomitant Omacetaxine Mepesuccinate and Azacitidine for Patients With Previously Untreated High Grade Myelodysplastic Syndromes | ||||
Brief Summary | This study will treat patients with previously untreated high grade myleodysplastic syndromes (MDS) with both omacetaxine mepesuccinate and azacitidine. | ||||
Detailed Description | This is an open-label, phase I/II study for previously untreated patients with high grade MDS using omacetaxine and azacitidine with a small expansion cohort for relapsed and refractory MDS patients. Phase I features dose escalation, where patients will be assigned to one of three cohorts to receive different doses of omacetaxine with the standard dose and schedule of azacitidine, over a 28 day cycle. Phase II features the maximum tolerated dose from the Phase 1 study. An additional expansion cohort of 10 MDS patients who have failed to respond to or responded and relapsed after at least one line of therapy containing a hypomethylating agent therapy will also be accrued. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | High Grade Myelodysplastic Syndromes | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
29 | ||||
Original Estimated Enrollment ICMJE |
51 | ||||
Estimated Study Completion Date ICMJE | June 2026 | ||||
Estimated Primary Completion Date | December 14, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: A subject will be eligible for study participation if he/she meets the following criteria within 14 days prior to the first day of therapy (bone marrow biopsy can be performed 28 days prior to the first day of therapy).
Exclusion Criteria: A subject will not be eligible for study participation if he/she meets any of the following criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03564873 | ||||
Other Study ID Numbers ICMJE | 17-2215.cc | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | University of Colorado, Denver | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | University of Colorado, Denver | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | University of Colorado, Denver | ||||
Verification Date | May 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |