Source: http://www.rochetrials.com/trialDetailsGet.action?studyNumber=NO21884&productGenericName=RG1507&productType=Drug&divisionName=PHA
Timestamp: 2013-06-19 12:24:15
Document Index: 666667458

Matched Legal Cases: ['art 1', 'art 2', 'art 1', 'art 1', 'art 2', 'art 1', 'art 2', 'art 2', 'art 2']

Protocol number: NO21884
NO21884
Multiple Ascending Dose (MAD) Phase Ib/II study of the mTOR inhibitor (RAD001) in combination with the IGF-1R Antagonist (R1507) for the treatment of patients with advanced solid tumors
This 2 part study will assess the safety, tolerability and efficacy of a combination of oral daily RAD001 and intravenous 3-weekly R1507 in patients with advanced solid tumors. In Part 1 of the study, patients will be enrolled sequentially to receive 5mg by mouth (po) RAD001 daily + 16mg/kg intravenous (iv) R1507 every 3 weeks (level 1) and if tolerated, 10mg po RAD001 daily + 16mg/kg iv R1507 every 3 weeks (level 2).In Part 2 of the study, patients with 1) advanced renal cell cancer and 2) advanced pancreatic neuroendocrine tumors will receive the maximum tolerated dose regimen from Part 1 (5mg or 10mg po RAD001 + 16mg/kg iv R1507). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is 11.
Maximum tolerated dose of RAD001, in combination with R1507 (Part 1
Time frame: First 3 week cycle of treatment
Progression-free survival (Part 2)
Overall objective response rate; duration of response; overall survival
Time frame: Event driven; monitored throughout study
adult patients, >=18 years of age;histologically confirmed recurrent or refractory advanced solid tumor (Part 1);advanced metastatic renal cell cancer OR advanced metastatic pancreatic neuroendocrine tumors, with evidence of progressive disease (Part 2);measurable disease (Part 2);ECOG performance status 0-2.
prior treatment with agents acting via inhibition of IGF-IR pathway;prior treatment with agents acting via inhibition of mTOR (Part 2);untreated CNS metastases;current anti-cancer therapy, or radiotherapy or chemotherapy <=4 weeks prior to enrollment;other known malignancy requiring treatment.
16.04.2009 Date last updated: