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| ID | Type | Description | Link |
|---|---|---|---|
| GO00882 | 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 taxane-based chemotherapy regimens utilized in patients with locally recurrent or metastatic breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0980 | Drug | Oral repeating dose |
| |
| bevacizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and nature of dose-limiting toxicities (DLTs) | Through Day 22 | |
| Incidence, nature, and severity of adverse events | Through study completion, up to 1 year, or early discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of GDC-0980, paclitaxel and bevacizumab (including total exposure, maximum and minimum plasma concentration, time to maximum observed plasma concentration, plasma half-life) | Through Day 22 | |
| Duration of response | Assessed at periodic intervals until study completion, up to 1 year, or early discontinuation |
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Inclusion Criteria:
Exclusion Criteria:
For Arm B:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Lauchle, M.D. | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston | Massachusetts | 02115 | United States | |||
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| Drug |
Intravenous repeating dose |
|
| paclitaxel | Drug | Intravenous repeating dose |
|
| Progression-free survival (PFS) | Assessed at periodic intervals until study completion, up to 1 year, or early discontinuation |
| Objective tumor response | Assessed at periodic intervals until study completion, up to 1 year, or early discontinuation |
| Nashville |
| Tennessee |
| 37203 |
| United States |
| Leuven | 3000 | Belgium |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 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 |
| D017239 | Paclitaxel |
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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