RecruitingPhase 1NCT03838926

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


Sponsor

Vanda Pharmaceuticals

Enrollment

42 participants

Start Date

Sep 27, 2018

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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

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Interventions

DRUGTrichostatin A

Intravenous Infusion


Locations(11)

Vanda Investigational Site

Washington D.C., District of Columbia, United States

Vanda Investigational Site

Lafayette, Indiana, United States

Vanda Investigational Site

Hackensack, New Jersey, United States

Vanda Investigational Site

Seattle, Washington, 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

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NCT03838926


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