Clinical trial NCT00324129: A Phase I Study of MGCD0103 Given Three-Times Weekly In Patients With Leukemia Or Myelodysplastic Syndromes
Official title: A Phase I Study of MGCD0103 Given as a Three-Times Weekly Oral Dose In Patients With Leukemia Or Myelodysplastic Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leukemia
Myelodysplastic Syndromes
Keywords: Leukemia
Myelodysplastic Syndromes
Phase I
Lead sponsor: Mirati Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2006-05-10
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Safety and tolerability
timeFrame: 1 year (anticipated)
measure: Pharmacokinetics
timeFrame: 1 year (anticipated)
Secondary outcomes:
measure: Clinical Response
timeFrame: 1 year (anticipated)
measure: Dose limiting toxicities
timeFrame: 1 year (anticipated)
measure: Pharmacodynamics (histone acetylation, biomarkers)
timeFrame: 1 year (anticipated)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Anderson Cancer Center
state: Texas
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Sir Mortimer Davis-Jewish General Hospital
state: Quebec
Study officials:
affiliation: MethylGene Inc.
name: Gregory Reid, MSc, MBA
role: STUDY_DIRECTOR
References: