Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This multicenter, open-label, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RO5458640 in patients with advanced solid tumors. Cohorts of patients will receive ascending doses of RO5458640 intravenously, either weekly or every 2 weeks or every 3 weeks, until disease progression or unacceptable toxicity occurs.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5458640 | Drug | Multiple ascending doses intravenously, weekly or every 2 weeks or every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | approximately 2 years | |
| Dose Limiting Toxicity (DLT) according to CTEP Common Terminology Criteria for Adverse Events Version 4.0 | approximately 2 years | |
| Maximum Tolerated Dose (MTD) | approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: area under the concentration - time curve (AUC) on two administration schedules | approximately 2 years | |
| Tumor response according to RECIST criteria | approximately 2 years | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ottawa | Ontario | K1H 8L6 | Canada | |||
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Antigenicity: Human anti-human antibody [HAHA] profile |
| approximately 2 years |
| Toronto |
| Ontario |
| M5G 2M9 |
| Canada |
| København Ø | 2100 | Denmark |
| Amsterdam | 1066 CX | Netherlands |