Clinical Trial Results:
Estudio de fase I/II multicéntrico, abierto, de escalada de dosis, para evaluar la seguridad, farmacocinética y actividad de RO5083945, un anticuerpo glico-modificado anti-EGFR, en pacientes con tumores sólidos malignos metastáticos y/o localmente avanzados EGFR+.
Open-label, multicenter, dose-escalation Phase I/II study to evaluate safety, pharmacokinetics and activity of RO5083945, a Glycoengineered Antibody against EGFR, in patients with metastatic and/or locally advanced malignant EGFR+ Solid Tumors
Summary
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EudraCT number |
2007-005939-28 |
Trial protocol |
ES FR |
Global completion date |
21 Jun 2011
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
08 Jul 2016
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First version publication date |
04 Jun 2015
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Other versions |
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Summary report(s) |
BO21495 CSR synopsis |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.