Status:
COMPLETED
A Phase I Study of MGCD0103 Given Three-Times Weekly In Patients With Leukemia Or Myelodysplastic Syndromes
Lead Sponsor:
Mirati Therapeutics Inc.
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with leukemia or myelodysplastic syndromes.
Detailed Description
Phase I dose escalating study.
Eligibility Criteria
Inclusion
- Patients must have a diagnosis of one of the following:
- relapsed or refractory AML or ALL that has failed to respond to standard therapy, has progressed despite standard therapy
- relapsed or refractory Myelodysplastic Syndromes
- previously untreated AML or Myelodysplastic Syndromes in patients \> 60 years of age who refused or are not candidates for induction chemotherapy
- Patients with relapsed or refractory CML that has failed to respond to Imatinib therapy or standard therapy, has progressed despite standard therapy, or for which no standard therapy exists
- ECOG performance status of 0, 1, or 2
- Age ≥ 18 years
- Patients or their legal representative must be able to read, understand, and sign a written informed consent (approved by the IRB/EC) prior to study entry
Exclusion
- Patients with a history of another cancer other than basal cell carcinoma or cervical intraepithelial neoplasia
- Pregnant or lactating women
- Patients and their partners, if either are of childbearing potential, not using adequate birth control measures throughout the study and for 90 days following the last dose of study medication
- Patients with known meningeal metastasis(es)
- Patients with active or uncontrolled infections, or with a fever \>38.5 C
- Patients with serious illnesses, medical conditions, or other medical history, which would be likely to interfere with a patient's participation in the study
- Patients who have been treated with any investigational drug or anti-cancer therapy within 30 days of study start.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00324129
Start Date
February 1 2005
End Date
December 1 2008
Last Update
January 8 2015
Active Locations (3)
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1
Anderson Cancer Center
Houston, Texas, United States, 77030
2
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
3
Sir Mortimer Davis-Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2