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

Phase 1

Completed

• Conditions: Leukemia; Myelodysplastic Syndromes
• Interventions: Drug: MGCD0103

• Registration Number: NCT00324129
• Lead Sponsor: Mirati Therapeutics Inc.

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.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2006-05-08
• Study First Submitted QC: 2006-05-08
• Study First Posted: 2006-05-10
• Primary Completion: 2006-07
• Study Completion: 2008-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-06
• Last Update Posted: 2015-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	MGCD0103	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	1 year (anticipated)
Pharmacokinetics	1 year (anticipated)

Secondary Outcome Measures

Name	Time	Method
Dose limiting toxicities	1 year (anticipated)
Pharmacodynamics (histone acetylation, biomarkers)	1 year (anticipated)
Clinical Response	1 year (anticipated)

Trial Locations

Locations (3)

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Sir Mortimer Davis-Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada