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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-002298-11 |
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This study will determine the maximum tolerated dose and the dose limiting toxicities (Part 1 of study) and the activity (Part 2 of study) of RO5126766 in patients with metastatic or advanced solid tumors. In the first part of the study, groups of patients will by sequentially enrolled to receive ascending oral doses of RO5126766 daily for 28 days. The starting dose of 0.1mg will be escalated in subsequent groups of patients after a successful assessment of the safety and tolerability of the previous dose. In Part 2 of the study, patients with selected tumor types will be randomized to receive either the optimal biological dose or the maximum tolerated dose of RO5126766 daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5126766 | Drug | Administered orally daily for 28 days, at escalating doses (with a starting dose of 0.1mg) (Part 1). Optimal biological dose or maximum tolerated dose administered orally, daily (Part 2). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (Part 1) | Throughout study | |
| Tumor assessments (Part 2) | Event driven |
| Measure | Description | Time Frame |
|---|---|---|
| AEs and laboratory parameters, ophthalmological examination, pharmacokinetic parameters, pharmacodynamic parameters (Parts 1 and 2). | Throughout study |
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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 |
|---|---|---|---|---|---|---|
| Villejuif | 94805 | France | ||||
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C577924 | RO5126766 |
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| Barcelona |
| Barcelona |
| 08003 |
| Spain |
| Sutton | SM2 5PT | United Kingdom |