Clinical Trial Protocol Registry
A Multiple Ascending Dose Study of the mTOR Inhibitor (RAD001) in Combination With R1507 in Patients With Advanced Solid Tumors
- Active, not recruiting
- Protocol number:
- Hoffmann-La Roche
- Company division:
- Official Scientific Title:
- 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
- Brief summary:
- 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.
- Study phase:
- Study type:
- Interventional; Treatment; Non-randomized; Open label; Uncontrolled; Single group; Safety/efficacy study
- Primary outcome:
- Maximum tolerated dose of RAD001, in combination with R1507 (Part 1 Time frame: First 3 week cycle of treatment
- Progression-free survival (Part 2) Time frame: 24 weeks
- Key secondary outcomes:
- Overall objective response rate; duration of response; overall survival Time frame: Event driven; monitored throughout study
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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.
- Males or Females
- Age limits:
- Min: 18 years Max: N/A (No limit)
- Accepts healthy volunteers:
- Anticipated start date:
- November, 2009
- Trial registration date:
- Date last updated:
- New York, NY
- San Antonio, TX
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