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

Phase 1

Completed

• Conditions: Chronic Myeloid Leukemia; Acute Lymphocytic Leukemia

• Registration Number: NCT00352677
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-14
• Study First Submitted QC: 2006-07-14
• Study First Posted: 2006-07-17
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-29
• Last Update Posted: 2009-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	One year
To determine the safety profile (including acute and chronic toxicities) and tolerability of INNO-406 in this patient population.	One year

Secondary Outcome Measures

Name	Time	Method
To determine the pharmacokinetic (PK) profile of INNO-406.	One year
To assess BCR-ABL transcript levels and to analyze BCR-ABL mutations.	One year
To assess leukemia response rates in this patient population.	One year

Trial Locations

Locations (6)

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

University of Heidelberg Medical Clinic; 🇩🇪 Mannheim, Germany

Chaim Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel

Charite University of Medicine; 🇩🇪 Berlin, Germany

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States

Johann Wolfgang Goethe Universität; 🇩🇪 Frankfurt am Main, Germany