Status:
COMPLETED
Safety and Tolerability Study of INNO-406 to Treat Chronic Myeloid Leukemia or Acute Lymphocytic Leukemia
Lead Sponsor:
CytRx
Conditions:
Chronic Myeloid Leukemia
Acute Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
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 intolera...
Eligibility Criteria
Inclusion
- 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.
- Be ≥18 years old.
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
- Have an estimated life expectancy of ≥12 weeks.
- 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.
- 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).
- Have acceptable pre-treatment clinical laboratory results.
Exclusion
- Have received chemotherapy ≤1 week from the start of therapy, with the exception of hydroxyurea and corticosteroids.
- Have received imatinib ≤3 days prior to enrollment or have not recovered from side effects of imatinib therapy.
- Have impaired cardiac function.
- Have an active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment.
- Have clinically significant acute or chronic liver or renal disease considered unrelated to tumor.
- Have impaired gastrointestinal function that may significantly alter drug absorption (e.g., uncontrolled vomiting, ulcerative colitis, malabsorption, or small bowel resection).
- Are pregnant or lactating.
- Have psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
- Have not recovered from acute toxicity of all previous therapy prior to enrollment.
- 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.
- Have a history of another primary malignancy that is currently clinically significant or requires active intervention.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00352677
Start Date
July 1 2006
End Date
May 1 2008
Last Update
June 1 2009
Active Locations (6)
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1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
2
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
3
Charite University of Medicine
Berlin, Germany, 13353
4
Johann Wolfgang Goethe Universität
Frankfurt am Main, Germany, 60590