Resminostat (4SC-201) in Relapsed or Refractory Hodgkin's Lymphoma

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Resminostat (4SC-201) is effective and safe in the treatment of relapsed or refractory Hodgkin's Lymphoma.

Official Title
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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

Conditions
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Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: Resminostat (4SC-201)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resminostat (4SC-201)<br>oral administration | Drug: Resminostat (4SC-201)<br>* oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the best overall objective response rate (ORR) based on IWG criteria of Resminostat (4SC-201) in patients with refractory or relapsed Hodgkin's Lymphoma. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigation of the safety and tolerability of repeated oral doses of Resminostat (4SC-201) |  | 12 weeks | 
| Assessment of the overall survival (OS) |  | 12 weeks | 
| Determination of progression free survival (PFS), including radiological and symptomatic progression |  | 12 weeks | 
| Determination of time to progression (TTP), including objective and symptomatic progression |  | 12 weeks | 
| Determination of duration of response (DOR) |  | 12 weeks | 
| Assessment of the pharmacokinetics of Resminostat (4SC-201) after oral dosing |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hodgkin's Lymphoma, HDAC, 4SC-201, Resminostat, Phase II