Leukemia, Myelodysplastic Syndromes
Conditions
Keywords
Leukemia, Myelodysplastic Syndromes, Phase I
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.
Interventions
DRUGMGCD0103
MGCD0103 given orally three times per week.
Sponsors
Mirati Therapeutics Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability | 1 year (anticipated) |
| Pharmacokinetics | 1 year (anticipated) |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Response | 1 year (anticipated) |
| Dose limiting toxicities | 1 year (anticipated) |
| Pharmacodynamics (histone acetylation, biomarkers) | 1 year (anticipated) |
Countries
Canada, United States
Outcome results
None listed