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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021168-13 | EudraCT Number |
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This open-label 2-arm study will assess the pharmacokinetics, pharmacodynamics, safety and efficacy of RO5429083 in patients with metastatic and/or locally advanced CD44-expressing malignant solid tumors. In Part A, cohorts of patients will receive RO5429083 intravenously at escalating doses. In Part B, patients will receive 89Zr-labelled RO5429083 in Cycles 1 and/or 2, followed by RO5429083. For all patients there will be an option to continue treatment with RO5429083 until disease progression or unacceptable toxicity occurs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5429083 | Drug | Cohorts receiving multiple escalating doses iv |
| |
| RO5429083 |
| Measure | Description | Time Frame |
|---|---|---|
| Arm A: Safety (Incidence of adverse events related to study drug) | Until disease progression or unacceptable toxicity (approximately 2 years) | |
| Arm A: Maximum tolerated dose of RO5429083 | Until disease progression or unacceptable toxicity (approximately 2 years) | |
| Arm A: Tumor Growth Control Rate | Until disease progression or unacceptable toxicity (approximately 2 years) | |
| Arm B: Tissue distribution of RO5429083 assessed by positron emission tomography (PET) | Until disease progression or unacceptable toxicity (approximately 2 years) | |
| Arm A: Pharmacokinetics (serum levels of RO5429083) | Until disease progression or unacceptable toxicity (approximately 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Arm A: Recommended dose of RO5429083 for the extension cohort | Until disease progression or unacceptable toxicity (approximately 2 years) | |
| Arm A: Anti-tumor activity of RO5429083 | Until disease progression or unacceptable toxicity (approximately 2 years) |
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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 |
|---|---|---|---|---|---|---|
| Houston | Texas | 77030 | United States | |||
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Drug |
Cohorts receiving 89Zr-labelled RO5429083 plus RO5429083, followed by RO5429083 until disease progression |
|
| Arm B: Target saturation of 89Zr-labelled RO5429083 | Until disease progression or unacceptable toxicity (approximately 2 years) |
| Seattle |
| Washington |
| 98109 |
| United States |
| Paris | 75231 | France |
| Toulouse | 31059 | France |
| Amsterdam | 1081 HV | Netherlands |
| Nijmegen | 6500 HB | Netherlands |