Relapsed or refractory Hodgkin’s lymphoma MedDRA version: 12.0 Level: LLT Classification code 10020328 Term: Hodgkin's lymphoma
Conditions
Interventions
Product Name: 4SC-201
Product Code: 4SC-201
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: to be proposed
CAS Number: 864814-88-0
Current Sponsor code: 4SC-201
Other descriptive name:
Sponsors
4SC AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Patients must have histological or cytological evidence of Hodgkin’s lymphoma (all subtypes are acceptable). ? Patients must have relapsed HL after second or subsequent-line therapy or have a refractory disease defined as non-CR after or PD during first-line therapy and PD following 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 be > 18 years of age ? Patients must have an ECOG Performance Score of 0, 1 or 2 (Appendix A) ? Patients must have a life expectancy of at least 12 weeks ? Patients or their legal representatives must be able to comprehend and provide written informed consent ? Patients must have adequate bone marrow reserve as evidenced by: ? Absolute neutrophil count (ANC) > 1,500/µl ? Platelet count > 75,000/µl ? Patients must have adequate renal function as evidenced by a serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 ? Any gastrointestinal disorder that could interfere with the absorption of 4SC-201, such as active ulcerative colitis, Crohn’s disease, diabetic gastroparesis, or other syndromes characterized by malabsorption ? Therapy with agents known to prolong the QT interval (Appendix E) ? 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 2 medications for adequate control; diabetes mellitus with > 2 episodes of ketoacidosis in the preceding 12 months. ? Patients with any other medical, psychiatric or social condition, which in the opinion of the investigator would preclude participation in the trial, pose an undue medical hazard, interfere with the conduct of the trial or interfere with interpretation of the trial results ? Patients with a history of hypersensitivity reactions to any of the components of 4SC-201 ? Women who are pregnant or lactating or who are planning on becoming pregnant during the trial or for 90 days after completion of the trial ? Patients who have received an investigational therapy within 4 weeks of signing the informed consent for the current study ? Patients with a confirmed QTcF > 450 msec ? Patients with a history of, who were treated for, or who are suspected of having, hepatitis B, hepatitis C or HIV. Patients suspected of having any of these conditions should undergo appropriate evaluations prior to being enrolled in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to determine the best overall objective response rate (ORR) based on IWG criteria (20) of 4SC-201 in patients with refractory or relapsed HL;Secondary Objective: The secondary objectives of this trial are: • to investigate the safety and tolerability of repeated oral doses of 4SC-201 • to assess overall survival (OS) in patients treated with repeated oral doses of 4SC-201 • to determine progression free survival (PFS) in patients treated with repeated oral doses of 4SC-201, including radiological and symptomatic progression • to determine time to progression (TTP) in patients treated with repeated oral doses of 4SC-201 including objective and symptomatic progression • to determine duration of response (DOR) in patients treated with repeated oral doses of 4SC-201 • to assess the pharmacokinetics of 4SC-201 after oral dosing ;Primary end point(s): The objective response rate (ORR) will be defined as the best response over the course of a patient’s participation in the trial. For the purposes of this trial, objective response will be a complete response or partial response based on anatomical imaging according to the International Working Group (IWG) criteria, or stable anatomical disease with improvement in functional (PET) imaging. The ORR and the exact 95% confidence interval will be presented. The ORR will be evaluated on the efficacy population. | — |
Countries
Czech Republic
Outcome results
None listed