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A Phase 1 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:
NCT00741871
First received: August 22, 2008
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Lymphoma, Malignant
Hodgkin's Lymphoma
B Cell Lymphoma
Drug: SB1518
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies

Resource links provided by NLM:


Further study details as provided by S*BIO:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the safety and tolerability of SB1518, administered orally once daily in subjects with advanced lymphoid malignancies. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
  • To assess the pharmacokinetic and pharmacodynamic profile of SB1518. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: July 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741871

Locations
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
S*BIO
Investigators
Principal Investigator: Anas Younes, M.D. M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: S*BIO
ClinicalTrials.gov Identifier: NCT00741871     History of Changes
Other Study ID Numbers: SB1518-2007-002
Study First Received: August 22, 2008
Last Updated: April 19, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 20, 2014