Omacetaxine and Decitabine in Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS)

NCT02141477 | Terminated Phase 1 FDA Drug

• 2 other identifiers: 2013-0812NCI-2014-02157
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical research study is made up of 2 phases. The goal of Phase 1 of the study is to test the safety of the combination of omacetaxine and decitabine and to find the best dose to give to future patients. The goal of Phase 2 of the study is to learn if this dose can help to control AML and/or MDS. The safety will then continue to be studied.

Conditions

Leukemia

Keywords

Leukemia; Acute Myelogenous Leukemia; AML; High Risk Myelodysplastic Syndrome; MDS; Omacetaxine; Synribo; Homoharringtonine; Decitabine; Dacogen

Outcome Measures

Primary Outcomes (1)

• Safe Dose Combination of Omacetaxine (OM) and Decitabine (DAC)

  Safe dose defined as highest dose level with \</= 1 out of 6 patients experience a dose limiting toxicity (DLT) during first treatment cycle. DLT defined as clinically significant Grade 3 or 4 adverse event or abnormal laboratory value according to Common Toxicity Criteria for Adverse Effects (CTCAE) criteria assessed by treating physician as related to study drug (and unrelated to disease progression, intercurrent illness, or concomitant medications) occurring during the first 28 days on study.

  28 days

Secondary Outcomes (1)

• Complete Response Rate (CRR)

  8 weeks

Study Arms (1)

Omacetaxine + Decitabine

EXPERIMENTAL

Phase I and Phase II Omacetaxine Dose: 1.25 mg/m2 subcutaneously every 12 hours on Days 1 - 3 of a 28 day cycle. Phase I Starting Decitabine Dose: 20 mg/m2 by vein on Days 1 - 5 of a 28 day cycle. Phase II Starting Decitabine Dose: Maximum tolerated dose from Phase I.

Drug: Omacetaxine; Drug: Decitabine

Interventions

Omacetaxine DRUG

Phase I and Phase II Omacetaxine Dose: 1.25 mg/m2 subcutaneously every 12 hours on Days 1 - 3 of a 28 day cycle.

Also known as: Synribo, Homoharringtonine

Omacetaxine + Decitabine

Decitabine DRUG

Phase I Starting Decitabine Dose: 20 mg/m2 by vein on Days 1 - 5 of a 28 day cycle. Phase II Starting Decitabine Dose: Maximum tolerated dose from Phase I.

Also known as: Dacogen

Omacetaxine + Decitabine

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Previously untreated AML (\>/= 20% blasts) or AML M6. Patients with high-risk (intermediate-2 or high by IPSS or \>/= 10% blasts) MDS will also be eligible. Prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors, azacitidine), or hematopoietic growth factors is allowed. No prior chemotherapy is allowed except for a single or a two day dose of cytarabine (up to 3 g/m2) for emergency use is also allowed as prior therapy.
• Age \>/= 70 years.
• Eastern Cooperative Oncology Group (ECOG) performance status \</= 2.
• Adequate hepatic (serum total bilirubin \</= 1.5 x ULN, serum glutamate pyruvate transaminase (SGPT) and/or SGOT \</= 2.5 x ULN) and renal function (creatinine \</= 2.0 mg/dL).
• Patients must be willing and able to review, understand, and provide written consent before starting therapy.
• Men of childbearing potential who agree to use contraception prior to study entry and for the duration of participation.

You may not qualify if:

• New York Heart Association (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia and requiring therapy, uncontrolled hypertension (blood pressure \>/= 160 systolic and \>/= 110 diastolic not responsive to antihypertensive medication), uncontrolled diabetes mellitus, or congestive heart failure.
• Myocardial infarction in the previous 12 weeks (from the start of treatment).
• Active and uncontrolled disease/infection as judged by the treating physician.
• Acute promyelocytic leukemia (APL).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Teva Pharmaceuticals USA: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute

Interventions

Homoharringtonine; Decitabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid

Intervention Hierarchy (Ancestors)

Harringtonines; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 4 or More Rings; Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Elias Jabbour, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 19, 2014
• Study Start: May 6, 2015
• Primary Completion: June 22, 2017
• Study Completion: June 22, 2017
• Last Updated: February 13, 2018

Record last verified: 2018-02

Locations

US (1)