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Sponsored by: |
S*BIO |
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Information provided by: | S*BIO |
ClinicalTrials.gov Identifier: | NCT00741871 |
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 |
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) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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. |
Principal Investigator: | Anas Younes, M.D. | M.D. Anderson Cancer Center |
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: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00741871 |
Health Authority: | United States: Food and Drug Administration |
Lymphoid malignancies Hodgkin's Lymphoma Diffuse large B cell lymphoma |
Lymphoma, large-cell Lymphoma, B-Cell Lymphatic Diseases Lymphoma, Large B-Cell, Diffuse Hodgkin's disease Immunoproliferative Disorders |
Hodgkin lymphoma, adult B-cell lymphomas Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Hodgkin Disease Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |