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Tolerability and PK/PD of Multiple Oral Doses of CT53518 in Patients With Acute Myelogenous Leukemia


Phase 1
18 Years
N/A
Not Enrolling
Both
Acute Myelogenous Leukemia, Myelodysplastic Syndrome

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Trial Information

Tolerability and PK/PD of Multiple Oral Doses of CT53518 in Patients With Acute Myelogenous Leukemia


This is a Phase 1, open label, dose escalating study at five clinical sites to determine
dose limiting toxicity (DLT), maximum tolerated dose (MTD), pharmacokinetics, and the effect
on the peripheral and bone marrow blast count of an oral 28-day course of CT53518 in
patients with Acute Myelogenous Leukemia (AML) and myelodysplastic syndrome. This study
will confirm the tolerability and assess the effects on the peripheral and bone marrow blast
count of an oral 28-day course of CT53518 at or near the maximum tolerated dose in patients
with AML displaying a specified mutation of the FLT-3 gene, internal tandem duplication
(ITD).


Inclusion Criteria:



Each patient must meet the following inclusion criteria to be eligible to participate in
the study.

- Men and women who are over 18 years of age and have one of the following conditions:

- AML with relapse within 12 months of the completion of consolidation therapy who
are not to receive gemtuzumab-ozogamicin; or

- AML with relapse after 12 months of the completion of consolidation therapy for
whom, in the opinion of the investigator, the risk of alternative therapy
outweighs the possible benefit; or

- newly diagnosed AML refractory to conventional remission-induction chemotherapy
("refractory" is defined as >10% blasts in blood and/or bone marrow upon
recovery from two cycles of standard cytarabine-based induction chemotherapy);
or

- newly diagnosed, or previously treated AML, greater than 60 years of age and not
or no longer a candidate for conventional remission-induction chemotherapy or
gemtuzumab-ozogamicin

- No reproductive potential (surgically, post- menopausal, or using two methods of
contraception)

- Demonstrated FLT-3 gene, internal tandem duplication mutation

- ECOG performance status of 0 to 2

- Has not received cytoreductive drug therapy for at least 4 weeks, and has not
received hydroxyurea within 24 hours prior to first dose of the study drug

- Has not received a bone marrow transplant or peripheral blood stem cell transplant
within the last two months

- Able to read and give written informed consent and has signed a consent form approved
by the Investigator's Institutional Review Board (IRB)

Exclusion Criteria:

Patients meeting any of the following criteria are not eligible to participate in the
study:

- Participated in an investigational drug study in the last 30 days

- Serum Creatinine >2 mg/dL

- Evidence of a clinically significant liver disease by history, physical examination
and/or laboratory data (e.g. transaminases exceeding 3 x ULN and/or total bilirubin >
2 mg/dL

- Known to have used illicit drugs within the last 30 days

- Has an uncontrolled active infection

- Pregnant or nursing mother

- Candidate for conventional chemotherapy (except hydroxyurea), including growth
factors or hormonal therapy for cancer

- Any concomitant disease or condition which could interfere with or for which the
treatment might interfere with the conduct of the study the, or which would, in the
opinion of the Investigator and/or Sponsor, increase the risk of the patient's
participation in the study. This includes but is not limited to alcoholism, drug
dependency or abuse, psychiatric disease.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

01-301

NCT ID:

NCT00064584

Start Date:

May 2002

Completion Date:

July 2005

Related Keywords:

  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Oregon Health Sciences UniversityPortland, Oregon  
Ohio State University Medical CenterColumbus, Ohio  43210
UCLA Medical CenterLos Angeles, California  90095-7059
Dana Farber Cancer InstituteBoston, Massachusetts  02115