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

Myelodysplastic Syndromes Clinical Trial

Official title:

A Phase I/II Clinical Trial of Omacetaxine, Azacitidine, and G-CSF for Relapsed and/or Refractory Myelodysplastic Syndromes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02835794
• Other study ID #: IRB201601194
• Secondary ID: UF-MDS-OAG-101
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: June 30, 2016
• Last updated: May 1, 2017
• Start date: August 2016
• Est. completion date: December 2018

Study information

• Verified date: May 2017
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• Omacetaxine
Comparison of different doses of omacetaxine in combination with azacitidine and G-CSF
• Azacitidine
Comparison of different doses of omacetaxine in combination with azacitidine and G-CSF
• G-CSF
Comparison of different doses of omacetaxine in combination with azacitidine and G-CSF

Locations

Country	Name	City	State
United States	University of Florida Health Shands Cancer Hospital	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Teva Pharmaceutical Industries, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants who demonstrate changes in chromosome karyotype and genetic mutations		12 months
Primary	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.		28 days
Secondary	Number of participants with Hematologic Improvement (HI) as measured by hemoglobin, platelet count and neutrophil count.		12 months
Secondary	Number of participants with disease response as defined by International Working Group (IWG) 2006 criteria.		12 months
Secondary	Number of participants who achieve complete remission and how long the response lasts		24 months
Secondary	Length of time of survival for participants		24 months
Secondary	Incidences of Grade 3/4 adverse events directly related to the drug combination		24 months