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The study was terminated early by the Sponsor for reasons unrelated to patient safety or anti-tumor activity.
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The study consists of two stages. In Stage 1, maximum tolerated dose (MTD) will be determined. In Stage 2, additional patients will be treated at the MTD of GDC-0152.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0152 | Drug | Intravenous escalating dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and nature of dose-limiting toxicities | Through study completion or early study discontinuation | |
| Incidence, nature, and severity of adverse events | Through study completion or early study discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of GDC-0152 (total plasma exposure, maximum plasma concentration, and total plasma clearance) | Through study completion or early study discontinuation |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Iris Chan, M.D., Ph.D. | Genentech, Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22623056 | Derived | Shin YG, Jones SA, Murakami SC, Budha N, Ware J, Wong H, Buonarati MH, Dean B, Hop CE. Validation and application of a liquid chromatography-tandem mass spectrometric method for the determination of GDC-0152 in human plasma using solid-phase extraction. Biomed Chromatogr. 2013 Jan;27(1):102-10. doi: 10.1002/bmc.2754. Epub 2012 May 24. |
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| ID | Term |
|---|---|
| C579046 | GDC-0152 |
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