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

Hodgkin's Lymphoma Clinical Trial

— SAPHIRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037478
• Other study ID #: 4SC-201-2-2009
• Status: Completed
• Phase: Phase 2
• First received: December 22, 2009
• Last updated: January 15, 2014
• Start date: December 2009
• Est. completion date: March 2013

Study information

• Verified date: January 2014
• Source: 4SC AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug ControlPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: March 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma
• Lymphoma

Intervention

Drug:
• Resminostat (4SC-201)
oral administration

Locations

Country	Name	City	State
Czech Republic	Fakultní nemocnice Brno	Brno
Czech Republic	Fakultní nemocnice Hradec Kralové	Hradec Kralové
Czech Republic	Fakultní nemocnice Kralovske Vinohrady	Praha
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Samodzielny Publiczny Szpital Kliniczny Nr.1 w Poznaniu	Poznan
Poland	Instytut im. Marii Sklodowskiej-Curie, Centrum Onkologii	Warsaw
Poland	Wojskowy Instytut Medyczny	Warsaw
Poland	Samodzielny Publiczny Szpital Kliniczny Nr.1 we Wroclawiu	Wroclaw
Romania	Institutul Clinic Fundeni	Bucharest
Romania	Spitalul Clinic Coltea	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
4SC AG

Countries where clinical trial is conducted

Czech Republic,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Investigation of the safety and tolerability of repeated oral doses of Resminostat (4SC-201)		12 weeks	Yes
Secondary	Assessment of the overall survival (OS)		12 weeks	No
Secondary	Determination of progression free survival (PFS), including radiological and symptomatic progression		12 weeks	No
Secondary	Determination of time to progression (TTP), including objective and symptomatic progression		12 weeks	No
Secondary	Determination of duration of response (DOR)		12 weeks	No
Secondary	Assessment of the pharmacokinetics of Resminostat (4SC-201) after oral dosing		12 weeks	No