EUCTR2009-014699-24-CZ
Active, not recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- 4SC AG
- Enrollment
- 45
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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 \< 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
Outcomes
Primary Outcomes
Not specified
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