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Safety and Efficacy Study of Pracinostat With Azacitadine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Helsinn Healthcare SA
ClinicalTrials.gov Identifier:
NCT01912274
First received: July 29, 2013
Last updated: February 23, 2017
Last verified: February 2017
  Purpose
The purpose of this study is to determine the safety and effectiveness of pracinostat when combined with azacitadine for patients who are 65 years of age or older and have Acute Myelogenous Leukemia (AML)

Condition Intervention Phase
Acute Myeloid Leukemia
Drug: pracinostat with azacitadine
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase II Open-Label, Single-arm, Two-Stage, Multicenter Trial of Pracinostat in Combination With Azacitidine in Elderly (Age 65 Years or Older) Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Resource links provided by NLM:


Further study details as provided by Helsinn Healthcare SA:

Primary Outcome Measures:
  • Estimate efficacy rate [ Time Frame: 6 months ]
    Estimate the rate of complete response (CR) + CR with incomplete blood count recovery (CRi) + morphologic leukemia free state (MLFS) to the combination of pracinostat and azacitidine.


Secondary Outcome Measures:
  • Overall response rate [ Time Frame: 6 months ]

    Estimate the overall response rate (ORR) (CR + CRi + partial response [PR]

    + PR with incomplete blood count recovery [PRi] + MLFS) to pracinostat plus azacitidine


  • Complete cytogenetic response [ Time Frame: 6 months ]
    Estimate the rate of complete cytogenetic response (CRc) to pracinostat plus azacitidine

  • Duration of response [ Time Frame: 6 months ]
    Estimate the rate of complete cytogenetic response (CRc) + molecular complete remission (CRm) to pracinostat plus azacitidine

  • Progression free survival [ Time Frame: 12 months ]
    Estimate the progression-free survival (PFS) duration after pracinostat plus azacitidine

  • Overall survival [ Time Frame: 6 - 24 months ]
    Estimate the overall survival (OS) duration after pracinostat plus azacitidine

  • Tolerability and AE profile [ Time Frame: 12 months ]
    Assess the tolerability and adverse event (AE) profile of pracinostat when combined with azacitidine


Estimated Enrollment: 50
Study Start Date: October 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pracinostat with azacitadine
60 mg of pracinostat by mouth 3 times a week for 3 weeks followed by 1 week of rest repeated every 28 days 75 mg/m2 azacitadine for the first 7 days of each 28 day cycle, via subcutaneous (SC) injection or intravenous (IV) infusion if SC injections are intolerable
Drug: pracinostat with azacitadine
Elderly newly diagnosed patients will all receive the combination of pracinostat with azacitadine
Other Name: SB939

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects aged ≥65 years.
  • Voluntary written informed consent before performance of any study related procedure not part of normal medical care.
  • Newly diagnosed de novo, secondary, or treatment-related AML with intermediate or unfavorable-risk cytogenetics based on the Southwest Oncology Group (SWOG) classifications (Slovak et al, 2000).
  • One prior cycle of therapy with an approved hypomethylating agent (HMA) such as azacitidine or decitabine is allowed for either an antecedent hematologic disorder (AHD) or AML. Patients are also eligible if they have received lenolidamide, immunosuppressive therapy or low dose chemotherapy for their AHD. Prior hydroxyurea is allowed.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • ≥20% blasts in bone marrow.
  • Peripheral WBC <30,000/uL.
  • Adequate organ function as evidenced by:
  • Total bilirubin 2x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)2.5x ULN
  • Serum creatinine 2x ULN
  • QT interval corrected according to Fridericia's formula (QTcF) ≤450 milliseconds (ms) for male subjects or ≤470 ms for female subjects on ECG at Screening.
  • Male subjects who are surgically sterile or willing to use adequate contraceptive measures or abstain from heterosexual intercourse during the entire study treatment period.
  • Female subjects who are not of childbearing potential.
  • Willingness and ability to understand the nature of this study and to comply with the study and follow up procedures

Exclusion Criteria:

  • Acute promyelocytic leukemia (French-American-British [FAB] M3 classification).
  • Known AML-associated t(15;17), t(8;21), t(16;16), del(16q), or inv(16) karyotype abnormalities.
  • Presence of a malignant disease within the last 12 months, with the exception of adequately treated in-situ carcinomas, basal or squamous cell carcinoma, or non-melanomatous skin cancer. Other malignancies will be considered on a case-by-case basis.
  • Life-threatening illnesses other than AML, uncontrolled medical conditions or organ system dysfunction that, in the Investigator's opinion, could compromise the subject's safety, or put the study outcomes at risk.
  • Uncontrolled or symptomatic arrhythmias, unstable angina, or any Class 3 or 4 cardiac diseases as defined by the New York Heart Association (NYHA) Functional Classification.
  • Clinical evidence of central nervous system (CNS) involvement.
  • Are candidates for intensive chemotherapy (induction chemotherapy, bone marrow, or stem cell transplant) within the next 4 months.
  • Received more than one prior cycle of HMA, previous bone marrow transplant or other intensive chemotherapy regimens for either an AHD or AML.
  • Received prior radiation therapy for extramedullary disease within 2 weeks of study enrollment.
  • Received prior histone deacetylase (HDAC) inhibitor or deacetylase (DAC) inhibitor is not permitted such as Istodax (romidepsin/depsipetide) or valproic acid.
  • Received hematopoietic growth factors: erythropoietin, granulocyte colony stimulating factor (G-CSF), granulocyte macrophage colony stimulating factor (GM-CSF), or thrombopoietin receptor agonists within 7 days (14 days for Aranesp) prior to study enrollment.
  • Have been treated with any chemotherapeutic agent within 2 weeks or 5 half-lives of the first dose of study drug, whichever is longer.
  • Are being treated with systemic corticosteroids. Inhaled and topical steroids as well as intermittent dexamethasone for nausea or vomiting are permitted.
  • Known history of human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV).
  • Uncontrolled active systemic infections.
  • Gastrointestinal (GI) tract disease, causing the inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, or uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis).
  • Any disease(s), psychiatric condition, metabolic dysfunction, or findings from a physical examination or clinical laboratory test result that would cause reasonable suspicion of a disease or condition, that contraindicates the use of study drugs, that may increase the risk associated with study participation, that may affect the interpretation of the results, or that would make the subject inappropriate for this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01912274

Locations
United States, California
City of Hope Comprehensive Cancer Ctr
Duarte, California, United States, 91010
USC Norrris Cancer Center
Los Angeles, California, United States, 90033
Bay Area Cancer Research Group
Pleasant Hill, California, United States, 94523
Stanford University School of Medicine
Stanford, California, United States, 94305-5821
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
Inidana Univ Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Mercy Medical Research Center
Springfield, Missouri, United States, 65807
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, New Jersey
Cooper Hospital
Camden, New Jersey, United States, 08103
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, South Carolina
Medical College of South Carolina-Hollings Cancer Ctr
Charleston, South Carolina, United States, 29425
United States, Texas
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-9179
MD Anderson
Houston, Texas, United States, 77030
United States, Wisconsin
Medical College of Wisconsin-Froedtert Cancer Center
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Helsinn Healthcare SA
Investigators
Principal Investigator: Guillermo Garcia-Manero, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: Helsinn Healthcare SA
ClinicalTrials.gov Identifier: NCT01912274     History of Changes
Other Study ID Numbers: MEI-004
Study First Received: July 29, 2013
Last Updated: February 23, 2017

Keywords provided by Helsinn Healthcare SA:
AML
open label
nonrandomized
single arm
elderly patients
HMA
newly diagnosed

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 25, 2017