Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hodgkin's Lymphoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Jan Walewski, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Czech Republic: State Institute for Drug Control

Study ID:

4SC-201-2-2009

NCT ID:

NCT01037478

Start Date:

December 2009

Completion Date:

March 2012

Related Keywords:

  • Hodgkin's Lymphoma
  • Hodgkin's Lymphoma
  • HDAC
  • 4SC-201
  • Resminostat
  • Phase II
  • Hodgkin Disease
  • Lymphoma

Name

Location