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

Phase 1

• Conditions: Relapsed or Refractory Hematologic Malignancies
• Interventions: Drug: Trichostatin A

• Registration Number: NCT03838926
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-27
• Status Verified: 2019-02
• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-11
• Last Update Submitted: 2019-02-11
• Study First Posted: 2019-02-12
• Last Update Posted: 2019-02-15
• Primary Completion: 2020-08
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trichostatin A	Trichostatin A	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of trichostatin A measured by spontaneous reporting of adverse events (AEs)	Up to 24 months	Measured by spontaneous reporting of adverse events (AEs)
Dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of trichostatin A	Up to 24 months

Trial Locations

Locations (1)

Vanda Investigational Site; 🇺🇸 Seattle, Washington, United States