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

May 29, 2009 updated by: CytRx

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: INNO-406

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Berlin, Germany, 13353
    - Charité University of Medicine
  - Frankfurt am Main, Germany, 60590
    - Johann Wolfgang Goethe Universität
  - Mannheim, Germany, 68305
    - University of Heidelberg Medical Clinic
Israel
- - Tel Hashomer, Israel, 52621
    - Chaim Sheba Medical Center
United States
- Florida
  - Tampa, Florida, United States, 33612
    - H. Lee Moffitt Cancer Center and Research Institute
- Texas
  - Houston, Texas, United States, 77030
    - University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CytRx

Investigators

Principal Investigator: Hagop Kantarjian, M.D., University of Texas, MD Anderson Cancer Center, Houston, TX 713-792-7026 hkantarj@mdanderson.org

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)