A Phase I Study of MGCD0103 Given Three-Times Weekly In Patients With Leukemia Or Myelodysplastic Syndromes

Mirati Therapeutics

Status and phase: Completed; Phase 1

Conditions: Leukemia; Myelodysplastic Syndromes

Treatments: Drug: MGCD0103

Study type: Interventional

Funder types: Industry

Identifiers

NCT00324129

0103-003

Details and patient eligibility

About

In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with leukemia or myelodysplastic syndromes.

Full description

Phase I dose escalating study.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

1

Experimental group

Treatment:

Drug: MGCD0103