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| ID | Type | Description | Link |
|---|---|---|---|
| MP00807 | Other Identifier | Hoffmann-La Roche |
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This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetic (PK) of GDC-0349 administered once daily (QD), orally (PO).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0349 | Drug | Oral escalating dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose limiting toxicities (DLTs) by NCI CTCAE v4.0 grade and associated dose of GDC-0349 | Up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events by NCI CTCAE v4.0 grade and associated dose of GDC-0349 | Up to 2 years | |
| Incidence of Grade 3 and 4 abnormalities in safety related laboratory parameters and associated dose of GDC-0349 | Up to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Holden, M.D. | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale | Arizona | 85258 | United States | |||
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C000620512 | GDC-0349 |
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| Toronto |
| Ontario |
| M5G 2M9 |
| Canada |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |