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

This study has been completed.
Sponsor:
Information provided by:
4SC AG
ClinicalTrials.gov Identifier:
NCT01037478
First received: December 22, 2009
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Hodgkin's Lymphoma
Drug: Resminostat (4SC-201)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by 4SC AG:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigation of the safety and tolerability of repeated oral doses of Resminostat (4SC-201) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Assessment of the overall survival (OS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Determination of progression free survival (PFS), including radiological and symptomatic progression [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Determination of time to progression (TTP), including objective and symptomatic progression [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Determination of duration of response (DOR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Assessment of the pharmacokinetics of Resminostat (4SC-201) after oral dosing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: December 2009
Study Completion Date: March 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resminostat (4SC-201)
oral administration
Drug: Resminostat (4SC-201)
oral administration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037478

Locations
Czech Republic
Fakultní nemocnice Brno
Brno, Czech Republic
Fakultní nemocnice Hradec Kralové
Hradec Kralové, Czech Republic
Fakultní nemocnice Kralovske Vinohrady
Praha, Czech Republic
Poland
Uniwersyteckie Centrum Kliniczne
Gdańsk, Poland
Samodzielny Publiczny Szpital Kliniczny Nr.1 w Poznaniu
Poznan, Poland
Wojskowy Instytut Medyczny
Warsaw, Poland
Instytut im. Marii Sklodowskiej-Curie, Centrum Onkologii
Warsaw, Poland
Samodzielny Publiczny Szpital Kliniczny Nr.1 we Wroclawiu
Wroclaw, Poland
Romania
Spitalul Clinic Coltea
Bucharest, Romania
Institutul Clinic Fundeni
Bucharest, Romania
Sponsors and Collaborators
4SC AG
Investigators
Principal Investigator: Jan Walewski, Prof. Instytut im. Marii Skłodowskiej-Curie, Centrum Onkologii, Warsaw, Poland
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01037478     History of Changes
Other Study ID Numbers: 4SC-201-2-2009
Study First Received: December 22, 2009
Last Updated: January 15, 2014
Health Authority: Czech Republic: State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency

Keywords provided by 4SC AG:
Hodgkin's Lymphoma
HDAC
4SC-201
Resminostat
Phase II

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 23, 2014