A Phase 2 Study of Tandutinib in Patients With Newly Diagnosed Acute Myelogenous Leukemia Who Are Considered Ineligible For or Who Decline Treatment With Standard Induction Therapy

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00297921
First received: February 27, 2006
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

Prospective, nonrandomized, noncomparative, open-label, multicenter, 2-stage clinical study designed to determine the overall response (combined complete remission, complete remission with incomplete blood count recovery, partial remission, or blast response) rate following tandutinib therapy in 2 groups of patients with newly diagnosed Acute Myelogenous Luekemia.


Condition Intervention Phase
Acute Myelogenous Leukemia
Drug: tandutinib
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Enrollment: 0
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, at least 18 years of age
  • Unequivocal histologic or cytologic diagnosis of AML (based on the WorldHealth Organization [WHO] and/or FAB classifications), excluding acute promyelocytic leukemia (FAB M3).
  • AML patients with a history of antecedent MDS or MPD are eligible for treatment in this study.
  • In the opinion of the investigator is ineligible for or has declined treatment with standard induction therapy
  • ECOG performance status of equal to or less then 3
  • Ability to voluntarily provide written informed consent
  • Determination of the presence or absence of a FLT3-ITD mutation before enrollment once it is ascertained that determination of FLT3-ITD mutation status is required to avoid exceeding enrollment in either patient group

Exclusion Criteria:

  • Presence of an active malignancy other than AML at the time of study entry
  • Documented or suspected central nervous system leukemia involvement
  • Known gastrointestinal disease that could interfere with the absorption of oral tandutinib
  • Severe central nervous system, pulmonary, renal, or hepatic disease not related to AML
  • Myocardial infarction within 6 months of enrollment or New York Heart Association (NYHA) Class III or Class IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia or active conduction system abnormalities
  • QTc >500 milliseconds (ms)
  • Family history of or congenital QTc prolongation
  • Pretreatment laboratory test values as follows:

    • Total bilirubin >2.5 x the upper limit of normal (ULN)
    • Alanine aminotransferase (ALT) >2.5 x the ULN
    • Serum creatinine >4.0 mg/dL
  • Known or suspected infection with human immunodeficiency virus
  • Known active infection with hepatitis B or hepatitis C
  • Known or suspected primary muscular or neuromuscular disease (eg, muscular dystrophy or myasthenia gravis)
  • Receipt of prior antineoplastic therapy for leukemia, except that prior therapy with the following is allowed:

    • Leukapheresis
    • Treatment for hyperleukocytosis with hydroxyurea
  • Receipt of prior antineoplastic therapy for MDS, except that prior therapy with the following is allowed:

    • Growth factor/cytokine support
    • Lenalidomide (Revlimid™)
    • Thalidomide (Thalomid®)
    • Azacitidine (Vidaza®)
    • Decitabine (Dacogen)
  • Receipt of prior antineoplastic therapy for MPD, except that prior therapy with the following is allowed:

    • Interferon alpha
    • Anagrelide (Agrylin®)
    • Hydroxyurea
  • Antineoplastic, experimental, or radiation therapy within 3 weeks before Day 1, except that hydroxyurea for the treatment of hyperleukocytosis is permitted
  • Major surgery within 2 weeks before Day 1
  • Men or women of childbearing potential unwilling to use adequate contraception from screening to 30 days after the last dose of tandutinib
  • A woman who is pregnant or breast feeding. Confirmation that the patient is not pregnant must be established by a negative serum or urine B-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during the screening period. Pregnancy testing is not required for postmenopausal or surgically sterilized women.
  • Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol
  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.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00297921     History of Changes
Other Study ID Numbers: C03002
Study First Received: February 27, 2006
Last Updated: November 4, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 22, 2014