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This study will determine the maximum tolerated dose and the optimal associated 4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with advanced solid tumors. A first cohort of patients will receive the starting dose of 20mg/m2/day, once daily for 10 days in each 28 day cycle. Subsequent cohorts of patients will receive dose escalations, and possible changes in dosing schedule, based on tolerability and pharmacokinetic knowledge gained from prior treatment cohorts. The anticipated time on study treatment is until disease progression or intolerable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5045337 | Drug | Administered po at escalating doses (with a starting dose of 20mg/m2/day) (5-10 cohorts) |
|
| Measure | Description | Time Frame |
|---|---|---|
| MTD and associated dose schedule | Every 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response | Event driven | |
| Dose-limiting toxicities. | Throughout study | |
| Pharmacokinetic profile |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora | Colorado | 80045 | United States | |||
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Throughout study |
| Comparison safety and tolerability of daily versus twice daily dosing regimens | approximately 18 months |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| New York | New York | 10065 | United States |
| Houston | Texas | 77030 | United States |
| San Antonio | Texas | 98229 | United States |
| Bordeaux | 33076 | France |
| Lyon | 69373 | France |