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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00352677
Other study ID # INNO-406
Secondary ID
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


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
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