Clinical trial NCT00352677: Safety and Tolerability Study of INNO-406 to Treat Chronic Myeloid Leukemia or Acute Lymphocytic Leukemia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Myeloid Leukemia
Acute Lymphocytic Leukemia
Lead sponsor: CytRx
Sponsor class: INDUSTRY
First posted: 2006-07-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 intolerant Philadelphia chromosome-positive (Ph+) leukemias.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: One year
measure: To determine the safety profile (including acute and chronic toxicities) and tolerability of INNO-406 in this patient population.
timeFrame: One year
Secondary outcomes:
measure: To determine the pharmacokinetic (PK) profile of INNO-406.
timeFrame: One year
measure: To assess BCR-ABL transcript levels and to analyze BCR-ABL mutations.
timeFrame: One year
measure: To assess leukemia response rates in this patient population.
timeFrame: One year
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Berlin
country: Germany
facility: Charite University of Medicine
city: Frankfurt am Main
country: Germany
facility: Johann Wolfgang Goethe Universität
city: Mannheim
country: Germany
facility: University of Heidelberg Medical Clinic
city: Tel Hashomer
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: University of Texas, MD Anderson Cancer Center, Houston, TX 713-792-7026 hkantarj@mdanderson.org
name: Hagop Kantarjian, M.D.
role: PRINCIPAL_INVESTIGATOR
References: