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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00741871
Recruitment Status : Completed
First Posted : August 26, 2008
Last Update Posted : April 20, 2012
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lymphoma, Malignant Hodgkin's Lymphoma B Cell Lymphoma Drug: SB1518 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies
Study Start Date : July 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Intervention Details:
  • Drug: SB1518
    SB1518 taken orally daily for 28 consecutive days in a 28 day cycle

Primary Outcome Measures :
  1. 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00741871

United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Principal Investigator: Anas Younes, M.D. M.D. Anderson Cancer Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: S*BIO Identifier: NCT00741871     History of Changes
Other Study ID Numbers: SB1518-2007-002
First Posted: August 26, 2008    Key Record Dates
Last Update Posted: April 20, 2012
Last Verified: April 2012

Keywords provided by S*BIO:
Lymphoid malignancies
Hodgkin's Lymphoma
Diffuse large B cell lymphoma

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