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

Sponsor
Mirati Therapeutics Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00324129
Collaborator
(none)
29
3
1
46
9.7
0.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Phase I dose escalating study.

Study Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Study of MGCD0103 Given as a Three-Times Weekly Oral Dose In Patients With Leukemia Or Myelodysplastic Syndromes
Study Start Date :
Feb 1, 2005
Actual Primary Completion Date :
Jul 1, 2006
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: MGCD0103
MGCD0103 given orally three times per week.

Outcome Measures

Primary Outcome Measures

  1. Safety and tolerability [1 year (anticipated)]

  2. Pharmacokinetics [1 year (anticipated)]

Secondary Outcome Measures

  1. Clinical Response [1 year (anticipated)]

  2. Dose limiting toxicities [1 year (anticipated)]

  3. Pharmacodynamics (histone acetylation, biomarkers) [1 year (anticipated)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anderson Cancer Center Houston Texas United States 77030
2 Princess Margaret Hospital Toronto Ontario Canada M5G 2M9
3 Sir Mortimer Davis-Jewish General Hospital Montreal Quebec Canada H3T 1E2

Sponsors and Collaborators

  • Mirati Therapeutics Inc.

Investigators

  • Study Director: Gregory Reid, MSc, MBA, MethylGene Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00324129
Other Study ID Numbers:
  • 0103-003
First Posted:
May 10, 2006
Last Update Posted:
Jan 8, 2015
Last Verified:
Jan 1, 2015

Study Results

No Results Posted as of Jan 8, 2015