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

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ClinicalTrials.gov Identifier: NCT03838926
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Hematologic Malignancies Drug: Trichostatin A Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies
Actual Study Start Date : September 27, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Experimental: Trichostatin A Drug: Trichostatin A
Intravenous Infusion




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838926


Contacts
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Contact: Vanda Pharmaceuticals 202-734-3400 clinicaltrials@vandapharma.com

Locations
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United States, District of Columbia
Vanda Investigational Site Recruiting
Washington, District of Columbia, United States, 20007
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Indiana
Vanda Investigational Site Recruiting
Lafayette, Indiana, United States, 47905
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Kansas
Vanda Investigational Site Recruiting
Fairway, Kansas, United States, 66205
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, New Jersey
Vanda Investigational Site Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Vanda Pharmaceuticals    202-734-3400      
United States, Washington
Vanda Investigational Site Recruiting
Seattle, Washington, United States, 98109
Contact: Vanda Pharmaceuticals    202-734-3400      
Sponsors and Collaborators
Vanda Pharmaceuticals

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Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03838926     History of Changes
Other Study ID Numbers: VP-VTR-297-1101
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vanda Pharmaceuticals:
Hematologic
Malignancies
Cancer
Blood
Additional relevant MeSH terms:
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Neoplasms
Trichostatin A
Antifungal Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histone Deacetylase Inhibitors