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

Sponsor

4SC AG (Industry)

Overall Status

Completed

CT.gov ID

NCT01037478

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

3.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

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 :

Dec 1, 2009

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Resminostat (4SC-201)

oral administration

Drug: Resminostat (4SC-201)

oral administration

Outcome Measures

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. [12 weeks]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	Fakultní nemocnice Brno	Brno	Czech Republic
2	Fakultní nemocnice Hradec Kralové	Hradec Kralové	Czech Republic
3	Fakultní nemocnice Kralovske Vinohrady	Praha	Czech Republic
4	Uniwersyteckie Centrum Kliniczne	Gdańsk	Poland
5	Samodzielny Publiczny Szpital Kliniczny Nr.1 w Poznaniu	Poznan	Poland
6	Instytut im. Marii Sklodowskiej-Curie, Centrum Onkologii	Warsaw	Poland
7	Wojskowy Instytut Medyczny	Warsaw	Poland
8	Samodzielny Publiczny Szpital Kliniczny Nr.1 we Wroclawiu	Wroclaw	Poland
9	Institutul Clinic Fundeni	Bucharest	Romania
10	Spitalul Clinic Coltea	Bucharest	Romania