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NCT03838926PHASE1Recruiting

Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies

Vanda Pharmaceuticals

Start Date

9/27/2018

Completion Date

12/1/2027

Summary

The aim of this study is to investigate the safety and tolerability of trichostatin A in individuals with relapsed or refractory hematologic malignancies.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Subject is ≥ 18 years at the time of signing informed consent; * Confirmed malignant hematologic disease or lymphoid malignancy that has relapsed or is refractory to standard therapy and has exhausted all available therapies; * Presence of measurable or evaluable disease; * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2; * Contraceptives or other approved avoidance of pregnancy measures Exclusion Criteria: * Allogeneic stem cell transplant recipient presenting with graft versus host disease (GVHD) either active or requiring immunosuppression; * Concomitantly taking anti-cancer therapy (bisphosphonates are permitted); * Undergone major surgery ≤ 2 weeks prior to starting study drug; * Evidence of mucosal or internal bleeding; * Impaired cardiac function or conduction defect; * Concurrent severe and/or uncontrolled medical conditions

Interventions

DRUG

Trichostatin A

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Conditions

Relapsed or Refractory Hematologic Malignancies

Locations

Vanda Investigational Site

Washington D.C., District of Columbia 20007

United States

Vanda Investigational Site

Lafayette, Indiana 47905

United States

Vanda Investigational Site

Hackensack, New Jersey 07601

United States

Vanda Investigational Site

Seattle, Washington 98109

United States

Vanda Investigational Site

Biała Podlaska,

Poland

Vanda Investigational Site

Katowice,

Poland

Vanda Investigational Site

Krakow,

Poland

Vanda Investigational Site

Opole,

Poland

Vanda Investigational Site

Skorzewo,

Poland

Vanda Investigational Site

Warsaw,

Poland

Vanda Investigational Site

Wroclaw,

Poland