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

Primary Purpose

Hodgkin's Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Resminostat (4SC-201)
Sponsored by
4SC AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin's Lymphoma focused on measuring Hodgkin's Lymphoma, HDAC, 4SC-201, Resminostat, Phase II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fakultní nemocnice Brno
  • Fakultní nemocnice Hradec Kralové
  • Fakultní nemocnice Kralovske Vinohrady
  • Uniwersyteckie Centrum Kliniczne
  • Samodzielny Publiczny Szpital Kliniczny Nr.1 w Poznaniu
  • Instytut im. Marii Sklodowskiej-Curie, Centrum Onkologii
  • Wojskowy Instytut Medyczny
  • Samodzielny Publiczny Szpital Kliniczny Nr.1 we Wroclawiu
  • Institutul Clinic Fundeni
  • Spitalul Clinic Coltea

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Resminostat (4SC-201)

Arm Description

oral administration

Outcomes

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 22, 2009
Last Updated
January 15, 2014
Sponsor
4SC AG
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1. Study Identification

Unique Protocol Identification Number
NCT01037478
Brief Title
Resminostat (4SC-201) in Relapsed or Refractory Hodgkin's Lymphoma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
4SC AG

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin's Lymphoma
Keywords
Hodgkin's Lymphoma, HDAC, 4SC-201, Resminostat, Phase II

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resminostat (4SC-201)
Arm Type
Experimental
Arm Description
oral administration
Intervention Type
Drug
Intervention Name(s)
Resminostat (4SC-201)
Intervention Description
oral administration
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Investigation of the safety and tolerability of repeated oral doses of Resminostat (4SC-201)
Time Frame
12 weeks
Title
Assessment of the overall survival (OS)
Time Frame
12 weeks
Title
Determination of progression free survival (PFS), including radiological and symptomatic progression
Time Frame
12 weeks
Title
Determination of time to progression (TTP), including objective and symptomatic progression
Time Frame
12 weeks
Title
Determination of duration of response (DOR)
Time Frame
12 weeks
Title
Assessment of the pharmacokinetics of Resminostat (4SC-201) after oral dosing
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Walewski, Prof.
Organizational Affiliation
Instytut im. Marii Skłodowskiej-Curie, Centrum Onkologii, Warsaw, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fakultní nemocnice Brno
City
Brno
Country
Czech Republic
Facility Name
Fakultní nemocnice Hradec Kralové
City
Hradec Kralové
Country
Czech Republic
Facility Name
Fakultní nemocnice Kralovske Vinohrady
City
Praha
Country
Czech Republic
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdańsk
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr.1 w Poznaniu
City
Poznan
Country
Poland
Facility Name
Instytut im. Marii Sklodowskiej-Curie, Centrum Onkologii
City
Warsaw
Country
Poland
Facility Name
Wojskowy Instytut Medyczny
City
Warsaw
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr.1 we Wroclawiu
City
Wroclaw
Country
Poland
Facility Name
Institutul Clinic Fundeni
City
Bucharest
Country
Romania
Facility Name
Spitalul Clinic Coltea
City
Bucharest
Country
Romania

12. IPD Sharing Statement

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

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