Omacetaxine for Consolidation and Maintenance

NCT ID: NCT01873495

Last Updated: 2019-09-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2018-07-31

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)

Study Design

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

Study Groups

Omacetaxine: Consolidation/Maintenance

Group Type: EXPERIMENTAL

Omacetaxine

Intervention Type: 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

Interventions

Omacetaxine

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

Intervention Type: DRUG

Other Intervention Names

Synribo

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of AML including de novo, secondary, or with an antecedent hematologic disorder (AHD) according to the World Health Organization (WHO) criteria.

2. Age ≥ 55 years.

3. 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.

4. Patients who received 1-2 cycles of hypomethylating therapy (decitabine azacitidine) are eligible.

5. Provide signed written informed consent.

6. Be able to comply with study procedures and follow-up examinations.

7. Be non-fertile or agree to use birth control during the study through the end of last treatment visit.

8. 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.

9. ECOG performance ≤ 2 at the time of second registration.

10. 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.

Exclusion Criteria

1. 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).

2. Prior treatment with omacetaxine.

3. Relapsed or refractory AML.

4. 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.

5. Psychiatric disorders that would interfere with consent, study participation, or follow-up.

6. 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).

7. 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).

8. Active carcinoma requiring systemic chemotherapy or radiation therapy.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Martha Arellano

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martha L. Arellano, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Winship2176-11

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00057844

Identifier Type: -

Identifier Source: org_study_id