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This is a Phase 2 study to assess the efficacy of SB1518 in the treatment of patients with advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent Lymphoma (follicular lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB1518 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB1518 | Drug | SB1518 taken orally daily for 28 consecutive days in a 28 day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess overall tumor response of SB1518 by CT/FDG-PET scan and bone marrow biopsy as applicable as a measure of efficacy | Outcome Measure - To assess the efficacy of SB1518 in the treatment of patients with advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent Lymphoma (follicular lymphoma, lymphophasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma). | Every even numbered cycle from baseline to 30 days after the last dose of study medication |
| Measure | Description | Time Frame |
|---|---|---|
| Assess durability of response | To assess the durability of response following SB1518 treatment in patients with advanced lymphoid malignancies. | Every even numbered cycle from baseline to 30 days after the last dose of study medication |
| Assess number of patients with adverse events as a measure of safety and tolerability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anas Younes, MD | MD Anderson Cancer Center at University of Texas, Houston | Principal Investigator |
| Jonathan Friedberg, MD | University of Rochester James P. Wilmot Cancer Center | Principal Investigator |
| Peter Martin, MD | Weill Medical College of Cornell University | Principal Investigator |
| Julie Vose, MD | University of Nebraska | Principal Investigator |
| Richard Klasa, MD | British Columbia Cancer Center - Vancouver Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States | ||
| Weill Medical College of Cornell |
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C561234 | 11-(2-pyrrolidin-1-ylethoxy)-14,19-dioxa-5,7,26-triazatetracyclo(19.3.1.1(2,6).1(8,12))heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene |
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To assess the safety and tolerability of SB1518 administered orally once daily in patients with advanced lymphoid malignancies. |
| Every even numbered cycle from baseline to 30 days after the last dose of study medication |
| New York |
| New York |
| 10021 |
| United States |
| University of Rochester James P. Wilmot Cancer Center | Rochester | New York | 14642 | United States |
| MD Anderson Cancer Canter | Houston | Texas | 77030 | United States |
| University of British Columbia | Vancouver | British Columbia | V5Z 4E6 | Canada |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |