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

RECRUITINGPhase 1Sponsored by Vanda Pharmaceuticals
Actively Recruiting
PhasePhase 1
SponsorVanda Pharmaceuticals
Started2018-09-27
Est. completion2025-12
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations4 sites

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

Age: 18 Years+Healthy volunteers 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

Conditions2

CancerRelapsed or Refractory Hematologic Malignancies

Locations4 sites

District of Columbia

1 site
Vanda Investigational Site
Washington D.C., District of Columbia, 20007

Indiana

1 site
Vanda Investigational Site
Lafayette, Indiana, 47905

New Jersey

1 site
Vanda Investigational Site
Hackensack, New Jersey, 07601

Washington

1 site
Vanda Investigational Site
Seattle, Washington, 98109

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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