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

Chronic Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00352677
• Other study ID #: INNO-406
• Status: Completed
• Phase: Phase 1
• First received: July 14, 2006
• Last updated: May 29, 2009
• Start date: July 2006
• Est. completion date: May 2008

Study information

• Verified date: May 2009
• Source: CytRx
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphocytic Leukemia
• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
Germany	Charite University of Medicine	Berlin
Germany	Johann Wolfgang Goethe Universität	Frankfurt am Main
Germany	University of Heidelberg Medical Clinic	Mannheim
Israel	Chaim Sheba Medical Center	Tel Hashomer
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
CytRx

Countries where clinical trial is conducted

United States,  Germany,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	To determine the safety profile (including acute and chronic toxicities) and tolerability of INNO-406 in this patient population.		One year	Yes
Secondary	To determine the pharmacokinetic (PK) profile of INNO-406.		One year	No
Secondary	To assess BCR-ABL transcript levels and to analyze BCR-ABL mutations.		One year	No
Secondary	To assess leukemia response rates in this patient population.		One year	No