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NCT Number: NCT03838926

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

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

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Key information

Conditions

Relapsed or Refractory Hematologic Malignancies Disease Attributes Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vanda Investigational Site, Biała Podlaska, Poland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trichostatin A

Drug

Intravenous Infusion

Primary outcomes

  1. Safety and tolerability of trichostatin A measured by spontaneous reporting of adverse events (AEs)

    Time frame: Up to 24 months

    Measured by spontaneous reporting of adverse events (AEs)

  2. Dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of trichostatin A

    Time frame: Up to 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Vanda Pharmaceuticals

CONTACT

[email protected]

202-734-3400

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Feb 12, 2019
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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