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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324129
• Other study ID #: 0103-003
• Status: Completed
• Phase: Phase 1
• First received: May 8, 2006
• Last updated: January 6, 2015
• Start date: February 2005
• Est. completion date: December 2008

Study information

• Verified date: January 2015
• Source: Mirati Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Description:

Phase I dose escalating study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2008
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• MGCD0103
MGCD0103 given orally three times per week.

Locations

Country	Name	City	State
Canada	Sir Mortimer Davis-Jewish General Hospital	Montreal	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
United States	Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Mirati Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability		1 year (anticipated)	Yes
Primary	Pharmacokinetics		1 year (anticipated)	No
Secondary	Clinical Response		1 year (anticipated)	No
Secondary	Dose limiting toxicities		1 year (anticipated)	Yes
Secondary	Pharmacodynamics (histone acetylation, biomarkers)		1 year (anticipated)	No