Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanda Pharmaceuticals
About this trial
The aim of this study is to investigate the safety and tolerability of trichostatin A in individuals with relapsed or refractory hematologic malignancies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Trichostatin A
DrugIntravenous Infusion
Treatment groups
42 Participants
are divided into 1 treatment groupGroup A: Trichostatin AExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and tolerability of trichostatin A measured by spontaneous reporting of adverse events (AEs)
Measured by spontaneous reporting of adverse events (AEs)
Time frame
Up to 24 months2
Dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of trichostatin A
Time frame
Up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov