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| ID | Type | Description | Link |
|---|---|---|---|
| GO01301 | 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 (PK) of oral (PO) GDC-0941 administered in combination with PO erlotinib in patients with advanced solid tumors and patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed at least one prior chemotherapy regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0941 | Drug | Oral repeating dose |
| |
| erlotinib HCl |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, nature, and severity of adverse events | Through study completion or early study discontinuation | |
| Tumor response | Assessed at periodic intervals |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of GDC-0941 (total exposure, and maximum and minimum serum concentrations) | Through study completion or early study discontinuation |
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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 |
|---|---|---|---|---|---|---|
| Aurora | Colorado | 80045 | United States | |||
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| Drug |
Oral repeating dose |
|
| New Brunswick |
| New Jersey |
| 08903 |
| United States |
| Amsterdam | 1066 EC | Netherlands |
| Utrecht | 3508 GA | Netherlands |
| ID | Term |
|---|---|
| C532162 | 2-(1H-indazol-4-yl)-6-(4-methanesulfonylpiperazin-1-ylmethyl)-4-morpholin-4-ylthieno(3,2-d)pyrimidine |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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