Recruiting
Phase 1

Trichostatin A

Sponsor:

Vanda Pharmaceuticals

Code:

NCT03838926

Conditions

Relapsed or Refractory Hematologic Malignancies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Trichostatin A

Study Details

Brief summary:

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

Conditions

Relapsed or Refractory Hematologic Malignancies

Study ID

NCT03838926

Start date

Sep 27, 2018

Status verified date

Feb, 2019

Completion date

Sep, 2020

Anticipated

Primary completion date

Aug, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

42 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Trichostatin A

Interventions

Trichostatin A

Intravenous Infusion

Primary outcome measure

  • Safety and tolerability of trichostatin A measured by spontaneous reporting of adverse events (AEs) [ Time Frame: Up to 24 months ]
  • Dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of trichostatin A [ Time Frame: Up to 24 months ]

Central Contacts and Locations

Central contacts

Vanda Pharmaceuticals

202-734-3400clinicaltrials@vandapharma.com

Locations

Vanda Investigational Site

Recruiting

Washington, District of Columbia, United States, 20007

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Lafayette, Indiana, United States, 47905

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Fairway, Kansas, United States, 66205

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Seattle, Washington, United States, 98109

Contacts

Vanda Pharmaceuticals

202-734-3400

More Information

Sponsor

Vanda Pharmaceuticals

Last update posted

Feb 15, 2019

Last verified

Feb, 2019

Keywords

  • Hematologic
  • Malignancies
  • Cancer
  • Blood

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vanda Pharmaceuticals on 2019-02-15.