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| ID | Type | Description | Link |
|---|---|---|---|
| GO00883 | Other Identifier | Hoffmann-La Roche |
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This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0980 administered in combination with capecitabine and with mFOLFOX6 chemotherapy with bevacizumab added on at Cycle 5 in patients with advanced or metastatic solid tumors.
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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 escalating dose |
| |
| bevacizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Up to 30 days after last dose of study treatment | |
| Incidence of dose limiting toxicities (DLTs) | Up to Day 21 for Arm A and up to Day 28 for Arm B | |
| Nature of adverse events graded according to NCI CTCAE, v4.0 | Up to 30 days after last dose of study treatment | |
| Nature of dose limiting toxicities (DLTs)graded according to NCI CTCAE, v4.0 | Up to 28 days | |
| Severity of adverse events | Up to 30 days after last dose of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Total exposure from Time 0 to the last measurable concentration | Up to Day 2 for Arm B and up to Day 9 for Arm A | |
| Maximum observed plasma concentration | Up to Day 2 for Arm B and up to Day 9 for Arm A |
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Inclusion Criteria:
Exclusion Criteria:
For Arm B:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90095 | United States | |||
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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 |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Drug |
Intravenous repeating dose |
|
| capecitabine | Drug | Oral repeating dose |
|
| mFOLFOX6 | Drug | Intravenous repeating dose |
|
| Minimum observed plasma concentration | Up to Day 2 for Arm B and up to Day 9 for Arm A |
| Time to maximum observed plasma concentration | Up to Day 2 for Arm B and up to Day 9 for Arm A |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Rochester | Minnesota | 55905 | United States |
| Barcelona | Barcelona | 08035 | Spain |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |