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

February 11, 2019 updated by: Vanda Pharmaceuticals
The aim of this study is to investigate the safety and tolerability of trichostatin A in individuals with relapsed or refractory hematologic malignancies.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • Vanda Investigational Site
    • Indiana
      • Lafayette, Indiana, United States, 47905
        • Recruiting
        • Vanda Investigational Site
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Recruiting
        • Vanda Investigational Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Vanda Investigational Site
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Vanda Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trichostatin A
Drug: Trichostatin A
Intravenous Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Up to 24 months
Dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of trichostatin A
Time Frame: Up to 24 months
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanda Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2018

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

February 11, 2019

First Posted (Actual)

February 12, 2019

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 11, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VTR-297-1101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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