Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Chronic Myeloid Leukemia, Acute Lymphocytic Leukemia

Thank you

Trial Information

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, 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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

One year

Safety Issue:

Yes

Principal Investigator

Hagop Kantarjian, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Food and Drug Administration

Study ID:

INNO-406

NCT ID:

NCT00352677

Start Date:

July 2006

Completion Date:

May 2008

Related Keywords:

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

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
University of Texas MD Anderson Cancer CenterHouston, Texas  77030