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 - SAPHIRE
- Conditions
- Relapsed or refractory Hodgkin’s lymphomaMedDRA version: 12.0Level: LLTClassification code 10020328Term: Hodgkin's lymphoma
- Registration Number
- EUCTR2009-014699-24-CZ
- Lead Sponsor
- 4SC AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 45
?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 <2.0 mg/dl
?Patients must have adequate hepatic function as evidenced by a serum bilirubin < 2.0 mg/dl and serum asparatate aminotransferase (AST) and alanine aminotransferase (ALT) levels < 3X the ULN for the reference lab (< 5X the ULN if there is known to be hepatic involvement by HL)
?Patients must be fully recovered from the effects of any prior therapy for HL.
?Women of childbearing potential must have a negative urine or serum pregnancy test (a women is considered to be NOT of childbearing potential if she has undergone bilateral oophorectomy or if she has been menopausal without a menstrual period for 12 consecutive months)
?Women of childbearing potential as well as fertile men and their partners must agree to either abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method, such as condom and diaphragm)
?Men with partners of childbearing potential are requested to use barrier contraception in addition to having their partner use another method of contraception during the trial and until at least 3 months following the last administration of the study medication. Male patients will also be advised to abstain from sexual intercourse with pregnant or lactating women, or to use condoms.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
?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 < 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.
?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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method