A Phase 2 Proof of Concept Study to Evaluate the Efficacy, Safety and Pharmacokinetics of the HDAC Inhibitor 4SC-201 in Patients With Relapsed or Refractory Hodgkin's Lymphoma
Main
Inclusion Criteria:
- Patients must have histological or cytological evidence of Hodgkin's Lymphoma (all
subtypes are acceptable)
- Patients must have relapsed or refractory Hodgkin's Lymphoma (HL) defined as relapse
following initial therapy or lack of response to first line therapy and treatment
with second-line (salvage therapy). Patients may have also undergone high-dose
chemotherapy with autologous stem cell transplantation at least 12 weeks prior to
study entry
- Patients must have measurable anatomical disease present on CT scan
- Patients must have an ECOG Performance Score of 0, 1 or 2
Main Exclusion Criteria:
- Patients who have received previous treatment with an HDAC inhibitor
- Patients who have undergone allogeneic hematopoietic stem cell transplantation
- Patients with known or suspected involvement of the CNS by HL
- Patients treated with agents known to prolong the QT interval or with a confirmed
QTcF > 450 msec
- Patients with a history of other malignancies unless having undergone definitive
treatment more than 5 years prior to entry into the study and without evidence of
recurrent malignant disease, excluding patients with basal cell carcinoma of the
skin; superficial carcinoma of the bladder; carcinoma of the prostate with a current
PSA < 0.1 ng/ml; or cervical intraepithelial neoplasia
- Patients with a history of significant cardiovascular, neurological, endocrine,
gastrointestinal, respiratory or inflammatory illness that could preclude their
participation in the trial, pose an undue medical hazard or interfere with the
interpretation of the trial results, including, but not limited to, patients with
congestive heart failure (NYHA Class 3 or 4); unstable angina; cardiac arrhythmia;
recent (within the preceding 6 months) myocardial infarction or stroke; hypertension
requiring > 2 medications for adequate control; diabetes mellitus with > 2 episodes
of ketoacidosis in the preceding 12 months