Clinical Trials /

A Clinical Trial of Omacetaxine, Azacitidine, and Growth-Colony Stimulating Factor (G-CSF) for Myelodysplastic Syndromes (MDS)

NCT02835794

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.

Related Conditions:
  • Myelodysplastic Syndromes
Recruiting Status:

Withdrawn

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

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: UF-MDS-OAG-101
  • NCT ID: NCT02835794

Trial Conditions

  • Myelodysplastic Syndromes

Trial Interventions

DrugSynonymsArms
OmacetaxineSynriboArm 1
AzacitidineVidazaArm 1
G-CSFNeupogenArm 1

Trial 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.

Detailed Description

Trial Arms

NameTypeDescriptionInterventions
Arm 1ExperimentalOmacetaxine - 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:Both
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:Yes
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:No
Description:
Measure:Number of participants with disease response as defined by International Working Group (IWG) 2006 criteria.
Time Frame:12 months
Safety Issue:No
Description:
Measure:Number of participants who achieve complete remission and how long the response lasts
Time Frame:24 months
Safety Issue:No
Description:
Measure:Length of time of survival for participants
Time Frame:24 months
Safety Issue:No
Description:
Measure:Incidences of Grade 3/4 adverse events directly related to the drug combination
Time Frame:24 months
Safety Issue:Yes
Description:

Trial Keywords

  • Myelodysplastic Syndromes