Omacetaxine for Consolidation and Maintenance

NCT01873495 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB00057844Winship2176-11
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to assess the safety and tolerability of omacetaxine for consolidation in patients age 55 and older with acute myelogenous leukemia (AML) in first complete remission following induction with cytarabine and an anthracycline, and also to assess the safety and tolerability of omacetaxine for maintenance in patients age 55 and older with acute AML in first complete remission following 3 consolidation courses with omacetaxine.

Conditions

Acute Myelogenous Leukemia (AML)

Outcome Measures

Primary Outcomes (4)

• Disease Status Assessment Prior to Each Consolidation Cycle

  Disease status will be assessed by a bone marrow aspirate and biopsy prior to each of 3 consolidation cycles (to ensure that patients are still in remission).

  14 days

• Assessment of Disease Status

  Bone marrow biopsy and aspirate will be obtained.

  1 month

• Bone Marrow Aspirate to Confirm Continuous Remission

  Bone marrow aspirate to confirm continuous remission will be obtained before starting maintenance and at 3 and 6 months from the start of maintenance.

  3 months

• Maintenance Toxicities

  Toxicities will be monitored by history, physical examination, and laboratory monitoring during maintenance.

  24 weeks

Secondary Outcomes (1)

• Consolidation Toxicities

  12 weeks

Study Arms (1)

Omacetaxine: Consolidation/Maintenance

EXPERIMENTAL

Drug: Omacetaxine

Interventions

Omacetaxine DRUG

Omacetaxine 1.25 mg/m² sub-cutaneously twice daily for 5 consecutive days every 28 (± 8) days for 3 cycles. Patients in continuous remission after 3 cycles of consolidation will receive maintenance omacetaxine 1.25 mg/m² twice daily for 3 days, every 28 days for up to 6 cycles

Also known as: Synribo

Omacetaxine: Consolidation/Maintenance

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of AML including de novo, secondary, or with an antecedent hematologic disorder (AHD) according to the World Health Organization (WHO) criteria.
• Age ≥ 55 years.
• Patient eligible for standard induction chemotherapy based on Eastern Cooperative Oncology Group (ECOG) performance status and vital organ function at the discretion of the treating physician.
• Patients who received 1-2 cycles of hypomethylating therapy (decitabine azacitidine) are eligible.
• Provide signed written informed consent.
• Be able to comply with study procedures and follow-up examinations.
• Be non-fertile or agree to use birth control during the study through the end of last treatment visit.
• Adequate renal and hepatic function at the time of second registration:
• Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); and
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN; and
• Serum creatinine ≤ 1.2 x ULN.
• ECOG performance ≤ 2 at the time of second registration.
• Patients with a history of carcinoma in remission, on no therapy or on hormonal therapy for the adjuvant treatment of breast carcinoma or prostate carcinoma are included in the study.

You may not qualify if:

• Diagnosis of acute promyelocytic leukemia (APL, French-American-British \[FAB\] classification M3 or WHO classification of APL with t (15;17)(q22;q12), (PML/retinoic acid receptor alpha \[RARa\] and variants).
• Prior treatment with omacetaxine.
• Relapsed or refractory AML.
• Investigational agent received within 30 days prior to the first dose of study drug. If received any investigational agent prior to this time point, drug-related toxicities must have recovered to Grade 2 or less prior to first dose of study drug.
• Psychiatric disorders that would interfere with consent, study participation, or follow-up.
• Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
• Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo the proposed therapy. This includes uncontrolled hypertension and uncontrolled diabetes, as cases of life threatening hyperglycemia have been reported (using continuous infusion at higher doses of omacetaxine).
• Active carcinoma requiring systemic chemotherapy or radiation therapy.

Sponsors & Collaborators

• Emory University: lead
• Teva Pharmaceuticals USA: collaborator

Study Sites (1)

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Homoharringtonine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Harringtonines; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 4 or More Rings

Limitations and Caveats

Accrual was halted early due to the inability of 30% of subjects to complete the intended consolidation and maintenance.

Results Point of Contact

• Title: Martha Arellano, MD
• Organization: Emory University

marella@emory.edu

404-778-1900

Study Officials

• Martha L. Arellano, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 10, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 24, 2019
• Results First Posted: September 24, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)