NCT00064584

Brief Summary

This is the first study of the drug CT53518 when given to humans. The purpose of this study is to determine the highest dose of CT53518 that can safely be given to patients with Acute Myelogenous Leukemia (AML) and to identify the side effects associated with taking the drug. The study will evaluate how CT53518 is absorbed, broken down, and eliminated by the body. Additionally, the study will evaluate the effects of the drug on a specific type of cell in bone marrow and blood, known as a blast.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2002

Typical duration for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
Last Updated

March 24, 2009

Status Verified

March 1, 2009

Enrollment Period

2.7 years

First QC Date

July 9, 2003

Last Update Submit

March 23, 2009

Conditions

Acute Myelogenous LeukemiaMyelodysplastic Syndrome

Interventions

CT53518DRUG

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97201, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic Syndromes

Interventions

tandutinib

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Study Design

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

Study Record Dates

First Submitted

July 9, 2003

First Posted

July 10, 2003

Study Start

May 1, 2002

Primary Completion

January 1, 2005

Study Completion

July 1, 2005

Last Updated

March 24, 2009

Record last verified: 2009-03

Locations

US(5)