Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)

Myelodysplastic Syndrome (MDS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00280631
• Other study ID #: TLK199.1101
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 19, 2006
• Last updated: May 30, 2012
• Start date: February 2006
• Est. completion date: June 2008

Study information

• Verified date: June 2011
• Source: Telik
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and efficacy of TLK199 Tablets in patients with Myelodysplastic Syndrome (MDS)

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Myelodysplastic Syndrome (MDS)
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• Ezatiostat Hydrochlorine
Oral Tablets in 2 Divided Doses, Dose Escalation From 200 mg Per Day to 6000 mg Per Day on Days 1-7 of each 21 Day Cycle.

Locations

Country	Name	City	State
United States	Loyola University Chicago-Cardinal Bernardin Cancer Center	Maywood	Illinois
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Massachusetts (UMass) Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Telik

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose or Optimal Biologic Dose		6 months	No
Secondary	Safety Pharmacokinetic Parameters, Hematologic Response Parameters		6 months	No