NCT00352677

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2006

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

June 1, 2009

Status Verified

May 1, 2009

Enrollment Period

1.8 years

First QC Date

July 14, 2006

Last Update Submit

May 29, 2009

Conditions

Chronic Myeloid LeukemiaAcute Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

Interventions

INNO-406DRUG

Oral, twice daily self-administration of 10 mg and/or 50 mg tablets

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Charite University of Medicine

Berlin, 13353, Germany

Location

Johann Wolfgang Goethe Universität

Frankfurt am Main, 60590, Germany

Location

University of Heidelberg Medical Clinic

Mannheim, 68305, Germany

Location

Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL PositivePrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

bafetinib

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Hagop Kantarjian, M.D.

    University of Texas, MD Anderson Cancer Center, Houston, TX 713-792-7026 hkantarj@mdanderson.org

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 14, 2006

First Posted

July 17, 2006

Study Start

July 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

June 1, 2009

Record last verified: 2009-05

Locations

US(2)DE(3)IL(1)