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| ID | Type | Description | Link |
|---|---|---|---|
| GO00767 | 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, pharmacokinetics (PK), and pharmacodynamics (PD) of GDC-0425 administered with and without gemcitabine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0425 | Drug | Oral escalating dose |
| |
| gemcitabine |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of all adverse events graded according to NCI CTCAE, v4.0 | Up to 1 year | |
| Incidence of dose limiting toxicities (DLTs) | Up to 35 days | |
| Pharmacokinetic property of GDC-0425: determination of plasma drug concentration | Up to 12 months or early study discontinuation | |
| Pharmacokinetic property of GDC-0425: exposure | Up to 12 months or early study discontinuation | |
| Pharmacokinetic property of GDC-0425: half-life | Up to 12 months or early study discontinuation | |
| Severity of all adverse events graded according to NCI CTCAE, v4.0 | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Antitumor activity of GDC-0425 in combination with gemcitabine: determination of tumor response using RECIST v1.1 for patients with measurable disease | Up to 12 months or early study 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 |
|---|---|---|---|---|---|---|
| Karmanos Cancer Institute.. | Detroit | Michigan | 48201 | United States | ||
| Sarah Cannon Cancer Center |
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| Drug |
Intravenous repeating dose |
|
| Nashville |
| Tennessee |
| 37203 |
| United States |
| Institut Gustave Roussy; Ser. de Med. Nucleaire; Cancerologie Endo | Villejuif | 94805 | France |
| ID | Term |
|---|---|
| C000614032 | GDC-0425 |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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