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This open-label, Phase I study will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of GDC-0853 in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia. In a dose-expansion part, GDC-0853 will be assessed in subsets of patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose-escalation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0853 | Drug | Multiple escalating doses |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of dose-limiting toxicities (DLTs) of GDC-0853 | Approximately 1 year | |
| Safety: Maximum tolerated dose (MTD) of GDC-0853 | Approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | Approximately 2 years | |
| Pharmacokinetics: Area under the concentration-time curve (AUC) of GDC-0853 | 35 days | |
| Pharmacokinetics: Maximum concentration (Cmax) of GDC-0853 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Center | Stanford | California | 94305-5820 | United States | ||
| Washington University School of Medicine |
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| 35 days |
| Objective response to GDC-0853 | Approximately 2 years |
| Progression-free survival | Approximately 2 years |
| St Louis |
| Missouri |
| 63110 |
| United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43212 | United States |
| Willamette Valley Cancer Ctr - 520 Country Club | Eugene | Oregon | 97401-8122 | United States |
| Oregon Health Sciences Uni | Portland | Oregon | 97239 | United States |
| Sarah Cannon Cancer Center - Tennessee Oncology, Pllc | Nashville | Tennessee | 37203 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology | Woolloongabba | Queensland | 4102 | Australia |
| Peter MacCallum Cancer Centre; Department of Haematology | Melbourne | Victoria | 3002 | Australia |
| Linear Clinical Research Limited | Nedlands | Western Australia | 6009 | Australia |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
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| ID | Term |
|---|---|
| C000619415 | fenebrutinib |
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