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

April 19, 2012 updated by: S*BIO

A Phase 2 Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • University of British Columbia
  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New York
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell
      • Rochester, New York, United States, 14642
        • University of Rochester James P. Wilmot Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Canter

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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);

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SB1518
Drug: SB1518
SB1518 taken orally daily for 28 consecutive days in a 28 day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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).
Every even numbered cycle from baseline to 30 days after the last dose of study medication

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess durability of response
Time Frame: 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.
Every even numbered cycle from baseline to 30 days after the last dose of study medication
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
To assess the safety and tolerability of SB1518 administered orally once daily in patients with advanced lymphoid malignancies.
Every even numbered cycle from baseline to 30 days after the last dose of study medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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: Julie Vose, MD, University of Nebraska
  • Principal Investigator: Richard Klasa, MD, British Columbia Cancer Center - Vancouver Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

December 16, 2010

First Submitted That Met QC Criteria

December 17, 2010

First Posted (Estimate)

December 21, 2010

Study Record Updates

Last Update Posted (Estimate)

April 20, 2012

Last Update Submitted That Met QC Criteria

April 19, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB1518-2010-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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