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

Primary Purpose

Leukemia, Myelodysplastic Syndromes

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
MGCD0103
Sponsored by
Mirati Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring Leukemia, Myelodysplastic Syndromes, Phase I

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Anderson Cancer Center
  • Princess Margaret Hospital
  • Sir Mortimer Davis-Jewish General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Safety and tolerability
Pharmacokinetics

Secondary Outcome Measures

Clinical Response
Dose limiting toxicities
Pharmacodynamics (histone acetylation, biomarkers)

Full Information

First Posted
May 8, 2006
Last Updated
January 6, 2015
Sponsor
Mirati Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00324129
Brief Title
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

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mirati Therapeutics Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelodysplastic Syndromes
Keywords
Leukemia, Myelodysplastic Syndromes, Phase I

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MGCD0103
Intervention Description
MGCD0103 given orally three times per week.
Primary Outcome Measure Information:
Title
Safety and tolerability
Time Frame
1 year (anticipated)
Title
Pharmacokinetics
Time Frame
1 year (anticipated)
Secondary Outcome Measure Information:
Title
Clinical Response
Time Frame
1 year (anticipated)
Title
Dose limiting toxicities
Time Frame
1 year (anticipated)
Title
Pharmacodynamics (histone acetylation, biomarkers)
Time Frame
1 year (anticipated)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Reid, MSc, MBA
Organizational Affiliation
MethylGene Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Sir Mortimer Davis-Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada

12. IPD Sharing Statement

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

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