NCT01037478

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2009

Typical duration for phase_2

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

January 16, 2014

Status Verified

January 1, 2014

Enrollment Period

2.1 years

First QC Date

December 22, 2009

Last Update Submit

January 15, 2014

Conditions

Hodgkin's Lymphoma

Keywords

Hodgkin's LymphomaHDAC4SC-201ResminostatPhase II

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Resminostat (4SC-201)

EXPERIMENTAL

oral administration

Drug: Resminostat (4SC-201)

Interventions

Resminostat (4SC-201)DRUG

oral administration

Resminostat (4SC-201)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Fakultní nemocnice Brno

Brno, Czechia

Location

Fakultní nemocnice Hradec Kralové

Hradec Kralové, Czechia

Location

Fakultní nemocnice Kralovske Vinohrady

Prague, Czechia

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr.1 w Poznaniu

Poznan, Poland

Location

Instytut im. Marii Sklodowskiej-Curie, Centrum Onkologii

Warsaw, Poland

Location

Wojskowy Instytut Medyczny

Warsaw, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr.1 we Wroclawiu

Wroclaw, Poland

Location

Institutul Clinic Fundeni

Bucharest, Romania

Location

Spitalul Clinic Coltea

Bucharest, Romania

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

resminostat

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Jan Walewski, Prof.

    Instytut im. Marii Skłodowskiej-Curie, Centrum Onkologii, Warsaw, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 23, 2009

Study Start

December 1, 2009

Primary Completion

January 1, 2012

Study Completion

March 1, 2013

Last Updated

January 16, 2014

Record last verified: 2014-01

Locations

CZ(3)RO(2)PL(5)