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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01037478
Recruitment Status : Completed
First Posted : December 23, 2009
Last Update Posted : January 16, 2014
Information provided by:

Brief 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.

Condition or disease Intervention/treatment Phase
Hodgkin's Lymphoma Drug: Resminostat (4SC-201) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Resminostat (4SC-201)
oral administration
Drug: Resminostat (4SC-201)
oral administration

Primary Outcome Measures :
  1. 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. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Investigation of the safety and tolerability of repeated oral doses of Resminostat (4SC-201) [ Time Frame: 12 weeks ]
  2. Assessment of the overall survival (OS) [ Time Frame: 12 weeks ]
  3. Determination of progression free survival (PFS), including radiological and symptomatic progression [ Time Frame: 12 weeks ]
  4. Determination of time to progression (TTP), including objective and symptomatic progression [ Time Frame: 12 weeks ]
  5. Determination of duration of response (DOR) [ Time Frame: 12 weeks ]
  6. Assessment of the pharmacokinetics of Resminostat (4SC-201) after oral dosing [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01037478

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Czech Republic
Fakultní nemocnice Brno
Brno, Czech Republic
Fakultní nemocnice Hradec Kralové
Hradec Kralové, Czech Republic
Fakultní nemocnice Kralovske Vinohrady
Praha, Czech Republic
Uniwersyteckie Centrum Kliniczne
Gdańsk, 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, Poland
Institutul Clinic Fundeni
Bucharest, Romania
Spitalul Clinic Coltea
Bucharest, Romania
Sponsors and Collaborators
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Principal Investigator: Jan Walewski, Prof. Instytut im. Marii Skłodowskiej-Curie, Centrum Onkologii, Warsaw, Poland
Layout table for additonal information Identifier: NCT01037478    
Other Study ID Numbers: 4SC-201-2-2009
First Posted: December 23, 2009    Key Record Dates
Last Update Posted: January 16, 2014
Last Verified: January 2014
Keywords provided by 4SC AG:
Hodgkin's Lymphoma
Phase II
Additional relevant MeSH terms:
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Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases