A Multiple Ascending Dose Study of the mTOR Inhibitor (RAD001) in Combination With R1507 in Patients With Advanced Solid Tumors
Stopped early · Phase 1
Conditions studied: Neoplasms
In brief
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.
Key facts
- Study ID
- NCT00985374
- Run by
- Hoffmann-La Roche
- People needed
- 11
- Starts
- 2009-11-01
- Expected to finish
- 2013-06-01
- Last updated by the study team
- 2016-11-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Study site — New York, New York, United States
- Study site — San Antonio, Texas, United States
- Study site — Milan, Lombardy, Italy
Full record on ClinicalTrials.gov
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