A Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies

Sponsor
S*BIO (Industry)
Overall Status
Completed
CT.gov ID
NCT01263899
Collaborator
(none)
28
5
1
14
5.6
0.4

Study Details

Study Description

Brief Summary

This is a Phase 2 study to assess the efficacy of SB1518 in the treatment of patients with advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent Lymphoma (follicular lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies
Study Start Date :
Dec 1, 2010
Actual Primary Completion Date :
Feb 1, 2012
Actual Study Completion Date :
Feb 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: SB1518

Drug: SB1518
SB1518 taken orally daily for 28 consecutive days in a 28 day cycle.

Outcome Measures

Primary Outcome Measures

  1. Assess overall tumor response of SB1518 by CT/FDG-PET scan and bone marrow biopsy as applicable as a measure of efficacy [Every even numbered cycle from baseline to 30 days after the last dose of study medication]

    Outcome Measure - To assess the efficacy of SB1518 in the treatment of patients with advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent Lymphoma (follicular lymphoma, lymphophasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma).

Secondary Outcome Measures

  1. Assess durability of response [Every even numbered cycle from baseline to 30 days after the last dose of study medication]

    To assess the durability of response following SB1518 treatment in patients with advanced lymphoid malignancies.

  2. Assess number of patients with adverse events as a measure of safety and tolerability [Every even numbered cycle from baseline to 30 days after the last dose of study medication]

    To assess the safety and tolerability of SB1518 administered orally once daily in patients with advanced lymphoid malignancies.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients with histologically documented diagnosis of one of the following lymphoid malignancies:

  • Hodgkin Lymphoma;

  • Mantle Cell Lymphoma;

  • Indolent Lymphoma (including follicular lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma);

  • Patients must have received at least one prior treatment regimen; patients with Hodgkin Lymphoma must have received an autologous stem cell transplant, refused or been deemed ineligible for stem cell transplant;

  • Able to understand and willing to sign the informed consent form.

Exclusion Criteria:
  • Any histology other than Hodgkin Lymphoma, Mantle Cell Lymphoma or Indolent Lymphoma;

  • History of or active Central Nervous System (CNS) malignancy;

  • Active graft-versus-host disease (GVHD);

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Nebraska Medical Center Omaha Nebraska United States 68198
2 Weill Medical College of Cornell New York New York United States 10021
3 University of Rochester James P. Wilmot Cancer Center Rochester New York United States 14642
4 MD Anderson Cancer Canter Houston Texas United States 77030
5 University of British Columbia Vancouver British Columbia Canada V5Z 4E6

Sponsors and Collaborators

  • S*BIO

Investigators

  • Principal Investigator: Anas Younes, MD, MD Anderson Cancer Center at University of Texas, Houston
  • Principal Investigator: Jonathan Friedberg, MD, University of Rochester James P. Wilmot Cancer Center
  • Principal Investigator: Peter Martin, MD, Weill Medical College of Cornell University
  • Principal Investigator: Julie Vose, MD, University of Nebraska
  • Principal Investigator: Richard Klasa, MD, British Columbia Cancer Center - Vancouver Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
S*BIO
ClinicalTrials.gov Identifier:
NCT01263899
Other Study ID Numbers:
  • SB1518-2010-005
  • NCT01263795
First Posted:
Dec 21, 2010
Last Update Posted:
Apr 20, 2012
Last Verified:
Apr 1, 2012

Study Results

No Results Posted as of Apr 20, 2012