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| ID | Type | Description | Link |
|---|---|---|---|
| GO01306 | Other Identifier | Hoffmann-La Roche |
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This is an open-label, multicenter, Phase I dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics (PK) of GDC-0917 in patients with refractory solid tumors or lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0917 | Drug | Oral repeating dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in vital signs, ECGs, and clinical laboratory results | Throughout study or until early discontinuation | |
| Incidence and nature of dose-limiting toxicities and adverse events of special interest | Throughout study or until early discontinuation | |
| Incidence, nature, and severity of all adverse events and serious adverse events | Throughout study or until early discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of GDC-0917 (including total exposure, maximum and minimum serum concentration, time to maximum observed plasma concentration, elimination of half-life, accumulation at steady-state) | Throughout study or until early discontinuation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chia Portera, M.D., Ph.D. | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nashville | Tennessee | 37203 | United States | |||
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| San Antonio |
| Texas |
| 98229 |
| United States |