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

Vanda Pharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Relapsed or Refractory Hematologic Malignancies

Treatments: Drug: Trichostatin A

Study type: Interventional

Funder types: Industry

Identifiers

NCT03838926

VP-VTR-297-1101

Details and patient eligibility

About

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

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

42 participants in 1 patient group

Trichostatin A

Experimental group

Treatment:

Drug: Trichostatin A