Relapsed or Refractory Hematologic Malignancies
Conditions
Keywords
Hematologic, Malignancies, Cancer, Blood
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.
Interventions
DRUGTrichostatin A
Intravenous Infusion
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Poland, United States
Contacts
CONTACTVanda Pharmaceuticals
Outcome results
None listed