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| ID | Type | Description | Link |
|---|---|---|---|
| GO00808 | Other Identifier | Hoffmann-La Roche |
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This is a Phase I, first-in-human, open label, dose-escalation study of MINT1526A administered alone and in combination with bevacizumab by IV infusion every 3 weeks to patients with advanced solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MINT1526A | Drug | Intravenous escalating dose |
| |
| bevacizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and nature of dose-limiting toxicities (DLTs) | Days 1 to 21 of cycle 1 | |
| Incidence, nature, and severity of adverse events and serious adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.0 | Day 1 to study completion |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of MINT1526A (including total exposure, maximum and minimum serum concentration, clearance, volume of distribution at steady state) | Following administration of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ina Rhee, M.D. | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Encinitas | California | 92008 | United States | |||
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| Drug |
Intravenous repeating dose |
|
| Los Angeles |
| California |
| 90095 |
| United States |
| Aurora | Colorado | 80045 | United States |
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| 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 |
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