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

Sponsor

CytRx (Industry)

Overall Status

Completed

CT.gov ID

NCT00352677

Collaborator

(none)

100

Enrollment

Locations

Duration (Months)

16.7

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloid Leukemia Acute Lymphocytic Leukemia	Drug: INNO-406	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2006

Actual Primary Completion Date :

May 1, 2008

Actual Study Completion Date :

May 1, 2008

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	University of Heidelberg Medical Clinic	Mannheim		Germany	68305
6	Chaim Sheba Medical Center	Tel Hashomer		Israel	52621