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

Relapsed or Refractory Hematologic Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03838926
• Other study ID #: VP-VTR-297-1101
• Status: Recruiting
• Phase: Phase 1
• Start date: September 27, 2018
• Est. completion date: September 2020

Study information

• Verified date: February 2019
• Source: Vanda Pharmaceuticals
• Contact: Vanda Pharmaceuticals
• Phone: 202-734-3400
• Email: clinicaltrials[@]vandapharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the safety and tolerability of trichostatin A in individuals with relapsed or refractory hematologic malignancies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: September 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Relapsed or Refractory Hematologic Malignancies

Intervention

Drug:
• Trichostatin A
Intravenous Infusion

Locations

Country	Name	City	State
United States	Vanda Investigational Site	Fairway	Kansas
United States	Vanda Investigational Site	Hackensack	New Jersey
United States	Vanda Investigational Site	Lafayette	Indiana
United States	Vanda Investigational Site	Seattle	Washington
United States	Vanda Investigational Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of trichostatin A measured by spontaneous reporting of adverse events (AEs)	Measured by spontaneous reporting of adverse events (AEs)	Up to 24 months
Primary	Dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of trichostatin A		Up to 24 months