A Phase 1 Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies

April 19, 2012 updated by: S*BIO
This is a Phase 1 dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when given alone once daily by mouth to subjects with advanced lymphoid malignancies.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

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

    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

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:

  • Subjects with histologically documented diagnosis of a lymphoid malignancy as defined in the World Health Organization (WHO) classification scheme except for those listed in Exclusion Criteria
  • Subject must have received at least 2 prior regimens for their lymphoid malignancy, one of which was an anthracycline-containing combination regimen and have shown disease relapse or did not respond to the prior regimen
  • Subjects with classic HL or diffuse large B cell lymphoma must have failed, refused or are ineligible to receive stem cell transplant
  • Subjects must have measurable lesions (at least one target lesion measuring 2cm in diameter) by computerized tomography (CT) scan
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • All men of reproductive potential and women of child-bearing potential must agree to practice effective contraception during the entire study period and for one month after the last study treatment unless documentation of infertility exists. Additionally, women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study drug
  • Able to understand and willing to sign the informed consent form

Exclusion Criteria:

  • Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, multiple myeloma, or HIV-associated lymphoma
  • History of or active Central Nervous System (CNS) malignancy
  • Have undergone allogeneic stem cell transplant and were treated with immunosuppressing agent within the past 6 months
  • Active Graft-versus-host disease (GVHD)
  • Uncontrolled inter-current illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as judged by treating physician. Subjects receiving antibiotics for infections that are under control may be included in the study
  • Concurrent malignancy, except those subjects with early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia are eligible for the study
  • Known HIV-positive (such subjects are at increased risk of lethal infections when treated with potentially marrow-suppressive therapy)
  • Known active Hepatitis A, B or C
  • Women who are pregnant or lactating

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily in subjects with advanced lymphoid malignancies.
Time Frame: Throughout the study
Throughout the study

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the safety and tolerability of SB1518, administered orally once daily in subjects with advanced lymphoid malignancies.
Time Frame: Throughout the study
Throughout the study
To assess the pharmacokinetic and pharmacodynamic profile of SB1518.
Time Frame: Throughout the study
Throughout the study

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Anas Younes, M.D., M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

July 1, 2008

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

August 22, 2008

First Submitted That Met QC Criteria

August 22, 2008

First Posted (Estimate)

August 26, 2008

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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