Description:
The purpose of this study is to determine the safety and establish the maximum tolerated dose
(MTD) of omacetaxine in combination with azacitidine and G-CSF in patients with relapsed
and/or refractory MDS.
Title
- Brief Title: A Clinical Trial of Omacetaxine, Azacitidine, and Growth-Colony Stimulating Factor (G-CSF) for Myelodysplastic Syndromes (MDS)
- Official Title: A Phase I/II Clinical Trial of Omacetaxine, Azacitidine, and G-CSF for Relapsed and/or Refractory Myelodysplastic Syndromes
Clinical Trial IDs
- ORG STUDY ID:
IRB201601194
- SECONDARY ID:
UF-MDS-OAG-101
- NCT ID:
NCT02835794
Conditions
- Myelodysplastic Syndromes
Interventions
Drug | Synonyms | Arms |
---|
Omacetaxine | Synribo | Arm 1 |
Azacitidine | Vidaza | Arm 1 |
G-CSF | Neupogen | Arm 1 |
Purpose
The purpose of this study is to determine the safety and establish the maximum tolerated dose
(MTD) of omacetaxine in combination with azacitidine and G-CSF in patients with relapsed
and/or refractory MDS.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm 1 | Experimental | Omacetaxine - escalating doses subcutaneous twice daily on Days 1-5 and 8-12 Azacitidine 50 mg/m2 subcutaneous/intravenous daily on Days 8-12 G-CSF 5mcg/kg subcutaneous daily on Days 15-19 and 22-26 | - Omacetaxine
- Azacitidine
- G-CSF
|
Eligibility Criteria
Inclusion Criteria:
- Age >= 18 years;
- Informed consent;
- Low- and intermediate-risk MDS that has failed to achieve any hematologic improvement
after at least 4 cycles of induction therapy or has relapsed after any duration of any
hematologic response. Prior therapy with azanucleosides (i.e., azacitidine,
decitabine), biologic therapies (i.e., lenalidomide, rigosertib) and hematopoietic
cell transplant are permissible;
- Performance status must be Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2;
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically
sterile) may participate, provided they meet the following conditions:
- Must agree to use physician-approved contraceptive methods throughout the study
and for three months following the last dose of omacetaxine and
- Must have a negative serum or urine pregnancy test within 7 days prior to
beginning treatment on this trial;
- Males with female partners of child-bearing potential must agree to use
physician-approved contraceptive methods throughout the study and should avoid
conceiving a child for 6 months following the last dose of omacetaxine.
Exclusion Criteria:
- Subjects who are eligible for hematopoietic stem cell transplant;
- History of atrial fibrillation related to azanucleoside therapy in the past;
- Active, uncontrolled, clinically significant infection;
- Pregnant and nursing patients are excluded because the effects of omacetaxine on a
fetus or nursing child are unknown;
- Treatment with any anticancer therapy (standard or investigational) within the
previous 14 days prior to the first dose of study drug or less than full recovery from
the clinically significant toxic effects of that treatment.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | The maximum tolerated dose (MTD) of omacetaxine in combination with azacitidine and G-CSF in patients with relapsed and/or refractory low- and intermediate-risk MDS. |
Time Frame: | 28 days |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Number of participants with Hematologic Improvement (HI) as measured by hemoglobin, platelet count and neutrophil count. |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Measure: | Number of participants with disease response as defined by International Working Group (IWG) 2006 criteria. |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Measure: | Number of participants who achieve complete remission and how long the response lasts |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Measure: | Length of time of survival for participants |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Measure: | Incidences of Grade 3/4 adverse events directly related to the drug combination |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Withdrawn |
Lead Sponsor: | University of Florida |
Trial Keywords
- Myelodysplastic Syndromes
Last Updated
May 3, 2017