A Phase I Study of MGCD0103 Given as a Three-Times Weekly Oral Dose In Patients With Leukemia Or Myelodysplastic Syndromes
Inclusion Criteria:
- 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 Criteria:
- 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.