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Safety and Tolerability Study of INNO-406 to Treat Chronic Myeloid Leukemia or Acute Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00352677
Recruitment Status : Completed
First Posted : July 17, 2006
Last Update Posted : June 1, 2009
Sponsor:
Information provided by:
CytRx

Brief Summary:
The purpose of this study is to determine the safety and effectiveness of INNO-406 in adult patients with imatinib-resistant or intolerant Philadelphia chromosome-positive (Ph+) leukemias.

Condition or disease Intervention/treatment Phase
Chronic Myeloid Leukemia Acute Lymphocytic Leukemia Drug: INNO-406 Phase 1

Detailed Description:
The purpose of this study is to determine the safety, tolerability and pharmacokinetic profile of INNO-406 when administered as a daily oral agent in adult patients with imatinib-resistant or intolerant Philadelphia chromosome-positive (Ph+) leukemias.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of INNO-406 in Adult Patients With Imatinib-Resistant or Intolerant Philadelphia Chromosome-Positive (Ph+) Leukemias
Study Start Date : July 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008



Intervention Details:
  • Drug: INNO-406
    Oral, twice daily self-administration of 10 mg and/or 50 mg tablets


Primary Outcome Measures :
  1. To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of INNO-406 when administered as a single agent to adult patients with imatinib-resistant or intolerant Ph+ leukemias. [ Time Frame: One year ]
  2. To determine the safety profile (including acute and chronic toxicities) and tolerability of INNO-406 in this patient population. [ Time Frame: One year ]

Secondary Outcome Measures :
  1. To determine the pharmacokinetic (PK) profile of INNO-406. [ Time Frame: One year ]
  2. To assess BCR-ABL transcript levels and to analyze BCR-ABL mutations. [ Time Frame: One year ]
  3. To assess leukemia response rates in this patient population. [ Time Frame: One year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have a confirmed diagnosis of Ph+ ALL or CML in chronic, accelerated, or blastic phases that are either resistant to or intolerant of imatinib therapy.
  2. Be ≥18 years old.
  3. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
  4. Have an estimated life expectancy of ≥12 weeks.
  5. Be male or non-pregnant, non-lactating female. Patients who are fertile must agree to use an effective barrier method of contraception while on therapy and for 90 days following discontinuation of study drug.
  6. Have a negative serum or urine pregnancy test within 7 days prior to the first dose of study drug (if patient is a female of childbearing potential).
  7. Have acceptable pre-treatment clinical laboratory results.

Exclusion Criteria:

  1. Have received chemotherapy ≤1 week from the start of therapy, with the exception of hydroxyurea and corticosteroids.
  2. Have received imatinib ≤3 days prior to enrollment or have not recovered from side effects of imatinib therapy.
  3. Have impaired cardiac function.
  4. Have an active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment.
  5. Have clinically significant acute or chronic liver or renal disease considered unrelated to tumor.
  6. Have impaired gastrointestinal function that may significantly alter drug absorption (e.g., uncontrolled vomiting, ulcerative colitis, malabsorption, or small bowel resection).
  7. Are pregnant or lactating.
  8. Have psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
  9. Have not recovered from acute toxicity of all previous therapy prior to enrollment.
  10. Have any other severe concurrent disease and/or uncontrolled medical conditions, which, in the judgment of the investigator, could predispose patients to unacceptable safety risks or compromise compliance with the protocol.
  11. Have a history of another primary malignancy that is currently clinically significant or requires active intervention.

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): NCT00352677


Locations
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United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Germany
Charite University of Medicine
Berlin, Germany, 13353
Johann Wolfgang Goethe Universität
Frankfurt am Main, Germany, 60590
University of Heidelberg Medical Clinic
Mannheim, Germany, 68305
Israel
Chaim Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
CytRx
Investigators
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Principal Investigator: Hagop Kantarjian, M.D. University of Texas, MD Anderson Cancer Center, Houston, TX 713-792-7026 hkantarj@mdanderson.org

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Responsible Party: Michael Dowd, Director, Product Development, Innovive Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00352677     History of Changes
Other Study ID Numbers: INNO-406
First Posted: July 17, 2006    Key Record Dates
Last Update Posted: June 1, 2009
Last Verified: May 2009
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Lymphoid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Bafetinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action