Clinical trial NCT01037478: Resminostat (4SC-201) in Relapsed or Refractory Hodgkin's Lymphoma
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hodgkin's Lymphoma
Keywords: Hodgkin's Lymphoma
HDAC
4SC-201
Resminostat
Phase II
Lead sponsor: 4SC AG
Sponsor class: INDUSTRY
First posted: 2009-12-23
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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.
timeFrame: 12 weeks
Secondary outcomes:
measure: Investigation of the safety and tolerability of repeated oral doses of Resminostat (4SC-201)
timeFrame: 12 weeks
measure: Assessment of the overall survival (OS)
timeFrame: 12 weeks
measure: Determination of progression free survival (PFS), including radiological and symptomatic progression
timeFrame: 12 weeks
measure: Determination of time to progression (TTP), including objective and symptomatic progression
timeFrame: 12 weeks
measure: Determination of duration of response (DOR)
timeFrame: 12 weeks
measure: Assessment of the pharmacokinetics of Resminostat (4SC-201) after oral dosing
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Fakultní nemocnice Brno
city: Hradec Kralové
country: Czech Republic
facility: Fakultní nemocnice Hradec Kralové
city: Praha
country: Czech Republic
facility: Fakultní nemocnice Kralovske Vinohrady
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Poznan
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr.1 w Poznaniu
city: Warsaw
country: Poland
facility: Instytut im. Marii Sklodowskiej-Curie, Centrum Onkologii
city: Warsaw
country: Poland
facility: Wojskowy Instytut Medyczny
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr.1 we Wroclawiu
city: Bucharest
country: Romania
facility: Institutul Clinic Fundeni
city: Bucharest
country: Romania
facility: Spitalul Clinic Coltea
Study officials:
affiliation: Instytut im. Marii Skłodowskiej-Curie, Centrum Onkologii, Warsaw, Poland
name: Jan Walewski, Prof.
role: PRINCIPAL_INVESTIGATOR
References: