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| ID | Type | Description | Link |
|---|---|---|---|
| GO01299 | Other Identifier | Hoffmann-La Roche |
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This is an open-label, Phase I, dose-escalation study using a 3 + 3 design to assess the safety, tolerability, and pharmacokinetics of orally administered GDC-0941 administered QD. This study will include patients with locally advanced or metastatic solid tumors, NHL, or multiple myeloma (MM) (expansion stage only) for which standard therapy either does not exist or has proven ineffective or intolerable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0941 | Drug | Escalating oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events by NCI CTCAE grade and associated dose of GDC-0941 | Through study completion or early study discontinuation | |
| Occurrence of dose-limiting toxicities (DLTs) by NCI CTCAE grade and associated dose of GDC-0941 | Through study completion or early study discontinuation | |
| Occurrence of Grade 3 or 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0941 | Through study completion or early study discontinuation | |
| PK parameters after single and multiple doses of GDC-0941 | Through study completion or early study discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Positron emission tomography (PET) response for patients with detectable FDG tumor uptake at baseline | Through study completion or early study discontinuation | |
| Best overall response, duration of objective response, and progression-free survival (PFS) for patients with measurable disease according to RECIST |
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Inclusion Criteria:
Exclusion Criteria:
Imbedded metallic material/devices (metal implants or large tattoos in the field of view)
Severe claustrophobia
Physical characteristics (weight or size) that exceed the capabilities of the MRI scanner
Known allergy or hypersensitivity reactions to gadolinium, verse
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| Name | Affiliation | Role |
|---|---|---|
| Gallia Levy, M.D. | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sutton | SM2 5PT | United Kingdom |
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| Through study completion or early study discontinuation |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C532162 | 2-(1H-indazol-4-yl)-6-(4-methanesulfonylpiperazin-1-ylmethyl)-4-morpholin-4-ylthieno(3,2-d)pyrimidine |
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