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

• Status: Unknown status
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanda Pharmaceuticals
• Treatments: Trichostatin A

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