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

January 15, 2014 updated by: 4SC AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Resminostat (4SC-201)
oral administration
Drug: Resminostat (4SC-201)
oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

4SC AG

Investigators

  • Principal Investigator: Jan Walewski, Prof., Instytut im. Marii Skłodowskiej-Curie, Centrum Onkologii, Warsaw, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

December 22, 2009

First Submitted That Met QC Criteria

December 22, 2009

First Posted (ESTIMATE)

December 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 16, 2014

Last Update Submitted That Met QC Criteria

January 15, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4SC-201-2-2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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