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


Phase 1
18 Years
N/A
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes

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Trial Information

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


Phase I dose escalating study.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and tolerability

Outcome Time Frame:

1 year (anticipated)

Safety Issue:

Yes

Principal Investigator

Gregory Reid, MSc, MBA

Investigator Role:

Study Director

Investigator Affiliation:

MethylGene Inc.

Authority:

United States: Food and Drug Administration

Study ID:

0103-003

NCT ID:

NCT00324129

Start Date:

February 2005

Completion Date:

December 2008

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • Leukemia
  • Myelodysplastic Syndromes
  • Phase I
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Anderson Cancer CenterHouston, Texas  77030