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Efficacy Study of Inecalcitol With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy

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ClinicalTrials.gov Identifier: NCT02802267
Recruitment Status : Recruiting
First Posted : June 16, 2016
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Hybrigenics Corporation

Brief Summary:
Evaluate the effect of the addition of inecalcitol to decitabine treatment on overall survival in previously untreated AML patients aged 65 years or more who are randomly assigned to receive decitabine with or without inecalcitol.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Drug: Inecalcitol Drug: Placebo Oral Tablet Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy Study of Inecalcitol in Combination With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy
Study Start Date : June 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: inecalcitol
Two tablets of Inecalcitol 2mg each (total 4mg) taken orally every other day.
Drug: Inecalcitol
vitamin D receptor agonist

Placebo Comparator: placebo
Two tablets of placebo 2mg each (total 4mg) taken orally every other day
Drug: Placebo Oral Tablet
placebo




Primary Outcome Measures :
  1. overall survival [ Time Frame: 24 months ]


Information from the National Library of Medicine

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

Inclusion Criteria:

• Patients aged 65 to < 75 years with at least one non severe comorbidity ie disease or syndrome with mild to moderate clinical or diagnostic observations or lab abnormalities which could increase the risk of toxicity and/or early death of intensive chemotherapy in the opinion of the investigator and are not contra-indicated for non-intensive chemotherapy.

or ≥ 75 years with or without any comorbidity at the time of the informed consent signature;

• Newly diagnosed, untreated de novo or secondary AML according to WHO classification;

Exclusion Criteria:

  • Prior or current treatment with chemotherapy for any myeloid disorder (excluding hydroxyurea) or radiotherapy for extramedullary involvement within 2 weeks of randomization;
  • Prior treatment with decitabine, azacitidine, or cytarabine;
  • Prior malignancies for 5 years with exception of basal cell, squamous cell carcinoma of the skin, or carcinoma " in situ " of the cervix or breast;
  • Chronic myelogenous or acute promyelocytic leukaemia;
  • Known CNS involvement;
  • Patient eligible to bone marrow or stem cell transplant;
  • WBC ≥ 30.000/mm3;
  • Impaired renal function with Creatinine clearance < 30 mL/min/1.73m² according to the MDRD formula;
  • Serum bilirubin ≥ 2.5 x ULN and/or AST and/or ALT ≥ 2.5 x ULN (upper limit of normal value);
  • Calcemia ≥ 2.65 mmol/L (106 mg/L) at screening assessment (corrected with albuminemia);
  • History of diseases known to be associated with calcium disorders: ongoing hyperparathyroidism, sarcoidosis….;
  • Presence or history of symptomatic kidney stones in the last 5 years;
  • Hypersensitivity to any of the excipients of decitabine (Potassium dihydrogen phosphate (E340) ; Sodium hydroxide (E524) ; Hydrochloric acid (for pH adjustment) or to the excipient of inecalcitol tablets (lactose);
  • Current use of drugs known to influence serum calcium (such as thiazide diuretics, teriparatide, calcitonin and multivitamin supplements containing > 400 IU of vitamin D or calcium);
  • Current use of digitalis;
  • Current use of drugs which could influence bioavailability of inecalcitol (such as magnesium-containing antacids, bile-resin binders);
  • Use of any other experimental drug or therapy or vitamin D supplementation within 4 weeks of randomization;
  • Known HIV;
  • Patients who are eligible for intensive induction therapy with curative intent;
  • Refractory congestive heart failure;
  • Active infection resistant to anti-infective therapy;
  • Documented pulmonary disease with DLCO ≤ 65% or FEV1≤ 65%, or dyspnea at rest or requiring oxygen, or any pleural neoplasm or uncontrolled lung neoplasm;
  • Liver cirrhosis Child B or C or acute viral hepatitis;
  • Current mental illness requiring psychiatric hospitalization, institutionalization or intensive outpatient management, or current cognitive status that produces dependence (as confirmed by the specialist) not controlled by the caregiver;
  • Uncontrolled neoplasia;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802267


Contacts
Contact: Shankar Srinivasan, PhD +1-2246221775 ssrinivasan@hybrigenics.com
Contact: Jean-Francois Dufour-Lamartinie, MD +33-158103805 jfdufour@hybrigenics.com

Locations
United States, California
Scripps Health Recruiting
San Diego, California, United States, 92103
Contact: Marin Xavier, M.D.         
Contact: Boyka S Petrov       Petrov.Boyka@scrippshealth.org   
United States, Georgia
Georgia Cancer Center-Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Jeremy M Pantin, M.D.         
Contact: Christine Sanchez       csanchez@augusta.edu   
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Khin Win, MBBS, CCRC       khin.win@usoncology.com   
Contact: Tiffany Gordon       tiffany.gordon@usoncology.com   
Principal Investigator: Edwin Kingsley, MD         
United States, New Mexico
New Mexico Cancer Care Alliance Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Kaylee Deutsch, MHA, CCRP       kdeutsch@nmcca.org   
Contact: April Encee, RN, OCN       aencee@salud.unm.edu   
Principal Investigator: Cecilia Arana-Yi, MD         
United States, North Carolina
Duke Cancer Institute, Duke Univ Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: David Rizzieri, M.D.         
Contact: Rachel Stowe       rachel.stowe@duke.edu   
United States, Texas
University of Texas; M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jorge Cortes, M.D.         
Contact: Jane A Autry       JAAutry@mdanderson.org   
United States, Wisconsin
ProHealth Care Inc Not yet recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Dawn Minikel       dawn.minikel@phci.org   
Contact: Amelia Crouse       amelia.crouse@phci.org   
Principal Investigator: Timothy Wassenaar, MD         
France
Necker Hospital- APHP Recruiting
Paris, France, 75015
Contact: Olivier Hermine, MD, PhD         
Sponsors and Collaborators
Hybrigenics Corporation
Investigators
Principal Investigator: Jean-Francois Dufour-Lamartinie, MD Hybrigenics Corporation

Responsible Party: Hybrigenics Corporation
ClinicalTrials.gov Identifier: NCT02802267     History of Changes
Other Study ID Numbers: ICT8
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Decitabine
Cholecalciferol
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents