A Phase 1 Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies - Full Text View

Sponsor:	S*BIO
Information provided by:	S*BIO
ClinicalTrials.gov Identifier:	NCT00741871

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 I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase 1 Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hodgkin Disease Lymphoma

U.S. FDA Resources

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 ]

Estimated Enrollment:	30
Study Start Date:	July 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Intervention Details:

The starting dose of SB1518 will be 100 mg 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
Has 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

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

Locations

United States, Texas
MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Amanda Copeland, MSN, CNS 713-792-9455 ARCopeland@mdanderson.org
Principal Investigator: Anas Younes, M.D.

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 PTE LTD ( Joy Zhu, M.D., Ph.D., Senior Vice President, Global Clinical Development )
Study ID Numbers:	SB1518-2007-002
Study First Received:	August 22, 2008
Last Updated:	February 10, 2009
ClinicalTrials.gov Identifier:	NCT00741871 History of Changes
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:

Lymphoma, B-Cell
Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type

Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease

ClinicalTrials.gov processed this record on February 08, 2010