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A multiple ascending dose study to evaluate the safety, tolerability and effect on tumor response of the mTOR inhibitor (RAD001) in combination with the IGF-1R antagonist (R1507) in patients with adva...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-005806-38

A multiple ascending dose study to evaluate the safety, tolerability and effect on tumor response of the mTOR inhibitor (RAD001) in combination with the IGF-1R antagonist (R1507) in patients with advanced solid tumors

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Extrait

P Ib: • To characterize the safety and tolerability of R1507 administered every 3 weeks in combination with daily RAD001 and to determine the maximum-tolerated dose (MTD) of RAD001 administered orally daily, in combination with R1507 administered intravenously every 3 weeks in patients with advanced solid malignancies, and to determine the recommended dose of RAD001 for the phase II study of the combined regimen. P II: • To assess the clinical activity of combination R1507 and RAD001 in two cohorts of patients, defined by: • PFS rate at 24 weeks, in a cohort of patients with advanced stage renal cell carcinoma [RCC cohort], • PFS rate at 24 weeks, in a cohort of patients with advanced low to intermediate grade metastatic or unresectable locoregional pancreatic neuroendocrine tumors (pNET) and carcinoid tumors, [NET cohort]. • NOTE: the NET cohort will be comprised of equal numbers of patients of 2 tumor subgroups, (pancreatic islet cell tumors and carcinoid tumors)

Critère d'inclusion

  • PIb: solid malignancy that is metastatic or unresectable PII: C 1: Advanced metastatic renal cell carcinoma C 2: Advanced low- to intermediate grade metastatic or unresectable locoregional pancreatic neuroendocrine tumors + carcinoid tumors

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