A Multiple Ascending Dose Study of the mTOR Inhibitor (RAD001) in Combination With R1507 in Patients With Advanced Solid Tumors
| Status: | Terminated |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2016 |
| Start Date: | November 2009 |
| End Date: | June 2013 |
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.
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.
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.
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3
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