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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005939-28 |
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This study will evaluate the pharmacokinetics, maximum tolerated dose and anti-tumor activity of RO5083945 in patients with metastatic and/or locally advanced malignant EGFR+ solid tumors. In the first part of the study, groups of patients will be sequentially enrolled to receive ascending doses of RO5083945 administered weekly, every 2 weeks or every 3 weeks. The starting dose of 50mg weekly will be escalated in subsequent groups of patients after a successful assessment of the safety, tolerability and pharmacokinetics of the previous dose. In Part 2 of the study, patients with EGFR+ and mutant KRAS colorectal cancer will be enrolled, and will receive RO5083945 at the recommended dose and regimen identified in Part 1. 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 |
|---|---|---|---|---|
| RO5083945 | Drug | Administered iv, either weekly, every 2 weeks or every 3 weeks, at escalating doses (with a starting dose of 50mg weekly (Part 1)). Recommended dose administered iv, either weekly, every 2 weeks or every 3 weeks (Part 2). |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters, and maximum tolerated dose (Part 1) | Throughout study | |
| Tumor growth control rate (CR, PR, SD) (Part 2) | Event driven |
| Measure | Description | Time Frame |
|---|---|---|
| AEs and laboratory parameters, pharmacodynamic parameters (Parts 1 and 2) | Throughout study | |
| Anti-tumor activity (ORR, DR, PFS) (Part 2) | Event driven |
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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 |
|---|---|---|---|---|---|---|
| Toulouse | 31059 | France | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21900113 | Derived | Paz-Ares LG, Gomez-Roca C, Delord JP, Cervantes A, Markman B, Corral J, Soria JC, Berge Y, Roda D, Russell-Yarde F, Hollingsworth S, Baselga J, Umana P, Manenti L, Tabernero J. Phase I pharmacokinetic and pharmacodynamic dose-escalation study of RG7160 (GA201), the first glycoengineered monoclonal antibody against the epidermal growth factor receptor, in patients with advanced solid tumors. J Clin Oncol. 2011 Oct 1;29(28):3783-90. doi: 10.1200/JCO.2011.34.8888. Epub 2011 Sep 6. |
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| Villejuif |
| 94805 |
| France |
| Barcelona | Barcelona | 08035 | Spain |
| Seville | Sevilla | 41013 | Spain |
| Valencia | Valencia | 46010 | Spain |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C569293 | imgatuzumab |
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