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| ID | Type | Description | Link |
|---|---|---|---|
| GO01336 | Other Identifier | Hoffmann-La Roche |
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This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0980 administered with either paclitaxel and carboplatin (with or without bevacizumab) or pemetrexed and cisplatin to patients with locally advanced or metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
| |
| C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0980 | Drug | Oral escalating dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first | |
| Incidence of dose limiting toxicities (DLTs) | Up to 21 days from Last Patient In (LPI) in Stage 1 of study | |
| Nature of adverse events | Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first | |
| Nature of dose limiting toxicities (DLTs) | Up to 21 days from Last Patient In (LPI) in Stage 1 of study | |
| Severity of adverse events | Up to 30 days after last dose of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Total exposure | Up to 32 months or early study discontinuation | |
| Maximum plasma concentration | Up to 32 months or early study discontinuation | |
| Time to maximum observed plasma concentration |
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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 |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90025 | United States | |||
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| bevacizumab |
| Drug |
Intravenous repeating dose |
|
| carboplatin | Drug | Intravenous repeating dose |
|
| cisplatin | Drug | intravenous repeating dose |
|
| paclitaxel | Drug | Intravenous repeating dose |
|
| pemetrexed | Drug | intravenous repeating dose |
|
| Up to 32 months or early study discontinuation |
| Plasma half-life | Up to 32 months or early study discontinuation |
| Tampa |
| Florida |
| 33612 |
| United States |
| Boston | Massachusetts | 02114 | United States |
| Boston | Massachusetts | 02215 | United States |
| Madrid | Madrid | 28050 | Spain |
| ID | Term |
|---|---|
| C569670 | 1-(4-((2-(2-aminopyrimidin-5-yl)-7-methyl-4-morpholinothieno(3,2-d)pyrimidin-6-yl)methyl)piperazin-1-yl)-2-hydroxypropan-1-one |
| D000068258 | Bevacizumab |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D017239 | Paclitaxel |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
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