Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
S*BIO
ClinicalTrials.gov Identifier:
NCT01263899
First received: December 16, 2010
Last updated: April 19, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Hodgkin Lymphoma
Mantle Cell Lymphoma
Indolent Lymphoma
 Drug: SB1518
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by S*BIO:

Primary Outcome Measures:
  • Assess overall tumor response of SB1518 by CT/FDG-PET scan and bone marrow biopsy as applicable as a measure of efficacy [ Time Frame: Every even numbered cycle from baseline to 30 days after the last dose of study medication ] [ Designated as safety issue: No ]
    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:
  • Assess durability of response [ Time Frame: Every even numbered cycle from baseline to 30 days after the last dose of study medication ] [ Designated as safety issue: No ]
    To assess the durability of response following SB1518 treatment in patients with advanced lymphoid malignancies.

  • Assess number of patients with adverse events as a measure of safety and tolerability [ Time Frame: Every even numbered cycle from baseline to 30 days after the last dose of study medication ] [ Designated as safety issue: Yes ]
    To assess the safety and tolerability of SB1518 administered orally once daily in patients with advanced lymphoid malignancies.


Enrollment: 28
Study Start Date: December 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SB1518 Drug: SB1518
SB1518 taken orally daily for 28 consecutive days in a 28 day cycle.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263899

Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New York
Weill Medical College of Cornell
New York, New York, United States, 10021
University of Rochester James P. Wilmot Cancer Center
Rochester, New York, United States, 14642
United States, Texas
MD Anderson Cancer Canter
Houston, Texas, United States, 77030
Canada, British Columbia
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
  More Information

No publications provided

Responsible Party: S*BIO
ClinicalTrials.gov Identifier: NCT01263899     History of Changes
Obsolete Identifiers: NCT01263795
Other Study ID Numbers: SB1518-2010-005
Study First Received: December 16, 2010
Last Updated: April 19, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by S*BIO:
Lymphoid malignancies
Hodgkin lymphoma
Mantle Cell Lymphoma
Indolent Lymphoma
SB1518

Additional relevant MeSH terms:
Neoplasms
Hodgkin Disease
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on May 23, 2013