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Phase 1-2a Dose-Ranging Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndrome (MDS)

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Trial Information

Phase 1-2a Dose-Ranging Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)


This Phase 1-2a study is an open label, dose‑ranging study of TLK199 Tablets in patients
with all World Health Organization or French‑American‑British classification types of
myelodysplastic syndrome (MDS). In Phase 1, the safety, pharmacokinetics, and hematologic
response rate with TLK199 Tablets will be evaluated. The Phase 1 dose‑ranging stage is
designed to determine the maximum tolerated dose or optimal biologic dose of TLK199 Tablets.
Evaluation of the pharmacokinetics of TLK199 Tablets will be conducted. In Phase 1, an
additional 12 patients will undergo pharmacokinetic evaluation under fed conditions at the
selected Phase 2a dose. In Phase 2a, further safety and hematologic responses by the
modified International Working Group MDS response criteria will be studied.


Inclusion Criteria:



- Histologically confirmed diagnosis of MDS

- Documented significant cytopenia for at least 2 months

- Adequate liver and kidney function

- Ineligible for stem cell bone marrow transplantation

- At least 18 years of age

- Discontinuation of growth factors (e.g., G-CSF) within 3 weeks of study entry

Exclusion Criteria:

- Prior bone marrow transplant

- Failure to recover from any prior surgery or any major surgery within 4 weeks of
study entry

- Pregnant or lactating women

- Other investigational drugs within 14 days of study entry

- Chemotherapy, radiotherapy or immunotherapy within 14 days of study entry

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum Tolerated Dose or Optimal Biologic Dose

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Gail Brown, MD

Investigator Role:

Study Director

Investigator Affiliation:

Telik

Authority:

United States: Food and Drug Administration

Study ID:

TLK199.1101

NCT ID:

NCT00280631

Start Date:

February 2006

Completion Date:

June 2008

Related Keywords:

  • Myelodysplastic Syndrome (MDS)
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location
Loyola University Medical Center Maywood, Illinois  60153
Loyola University Chicago-Cardinal Bernardin Cancer Center Maywood, Illinois  60153
University of Massachusetts (UMass) Memorial Medical Center Worcester, Massachusetts  01655