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

NCT ID: NCT02835794

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-12-31

Brief Summary

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.

Conditions

Myelodysplastic Syndromes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

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

Group Type: EXPERIMENTAL

Omacetaxine

Intervention Type: DRUG

Comparison of different doses of omacetaxine in combination with azacitidine and G-CSF

Azacitidine

Intervention Type: DRUG

Comparison of different doses of omacetaxine in combination with azacitidine and G-CSF

G-CSF

Intervention Type: DRUG

Comparison of different doses of omacetaxine in combination with azacitidine and G-CSF

Interventions

Omacetaxine

Comparison of different doses of omacetaxine in combination with azacitidine and G-CSF

Intervention Type: DRUG

Azacitidine

Comparison of different doses of omacetaxine in combination with azacitidine and G-CSF

Intervention Type: DRUG

G-CSF

Comparison of different doses of omacetaxine in combination with azacitidine and G-CSF

Intervention Type: DRUG

Other Intervention Names

Synribo; Vidaza; Neupogen

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Pharmaceutical Industries, Ltd.

INDUSTRY

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maxim N. Norkin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida Health Shands Cancer Hospital

Gainesville, Florida, United States

Countries

United States

Other Identifiers

UF-MDS-OAG-101

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201601194

Identifier Type: -

Identifier Source: org_study_id