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
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