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Safety and Tolerability Study of INNO-406 to Treat Chronic Myeloid Leukemia or Acute Lymphocytic Leukemia
This study has been completed.

First Received on July 14, 2006.   Last Updated on May 29, 2009   History of Changes
Sponsor: CytRx
Information provided by: CytRx
ClinicalTrials.gov Identifier: NCT00352677
  Purpose

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 Intervention Phase
Chronic Myeloid Leukemia
Acute Lymphocytic Leukemia
Drug: INNO-406
Phase I

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by CytRx:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • To determine the safety profile (including acute and chronic toxicities) and tolerability of INNO-406 in this patient population. [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the pharmacokinetic (PK) profile of INNO-406. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • To assess BCR-ABL transcript levels and to analyze BCR-ABL mutations. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • To assess leukemia response rates in this patient population. [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: INNO-406
    Oral, twice daily self-administration of 10 mg and/or 50 mg tablets
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00352677

Locations
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
Principal Investigator: Hagop Kantarjian, M.D. University of Texas, MD Anderson Cancer Center, Houston, TX 713-792-7026 hkantarj@mdanderson.org
  More Information

No publications provided

Responsible Party: Michael Dowd, Director, Product Development, Innovive Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00352677     History of Changes
Other Study ID Numbers: INNO-406
Study First Received: July 14, 2006
Last Updated: May 29, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012