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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-002021-77 |
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This study will determine the maximum tolerated dose and the dose-limiting toxicities of RO4987655 in patients with advanced and/or metastatic solid tumors. In the first part of the study, groups of patients will be sequentially enrolled to receive ascending oral doses of RO4987655 daily for 28 days. The starting dose of 1mg daily 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 metastatic or advanced malignant melanoma, or any other responsive tumor type, will be randomized to receive either the maximum tolerated dose or the optimal biological dose of RO4987655 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 |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO4987655 | Drug | Administered po daily for 28 days, at escalating doses, with a starting dose of 1mg (Part 1) maximum tolerated dose administered po daily until disease progression(Part 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (Part 1) | Reviewed after each 4 week cycle | |
| Tumor assessments (Part 2) | Every 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, laboratory parameters, PD parameters, optimal biological dose (Parts 1 and 2) | Reviewed after each 4 week cycle |
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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 |
|---|---|---|---|---|---|---|
| Marseille | 13385 | France | ||||
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C559138 | CH 4987655 |
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| RO4987655 | Drug | Administered po daily for 28 days, at escalating doses , with a starting dose of 1mg (Part 1). Optimal biological dose administered po daily until disease progression (Part 2) |
|
| Paris |
| 75231 |
| France |
| Paris | 75651 | France |
| Villejuif | 94805 | France |
| Essen | 45122 | Germany |
| Amsterdam | 1066 CX | Netherlands |
| Barcelona | Barcelona | 08003 | Spain |
| Madrid | Madrid | 28050 | Spain |
| Seville | Sevilla | 41013 | Spain |
| Cambridge | CB2 2QQ | United Kingdom |
| London | SW3 6JJ | United Kingdom |
| Oxford | OX3 7LJ | United Kingdom |