NCT00804336

Pasireotide in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors

Phase I Study of Pasireotide (SOM230) in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine the safety of the combination of SOM230 and RAD001, as well as determine the highest dose of this combination that can be given to people safely. SOM230 is an investigational drug that is similar to Sandostatin LAR. Sandostatin is an approved drug for the use of treating symptoms of neuroendocrine tumors. SOM230 has shown to be effective in patients who have become resistant to Sandostatin and may also stop cancer cells from growing. RAD001 is an investigational drug that also may stop cancer cells from growing.

Detailed description

* Participants will be receiving two study medications, SOM230 and RAD001, during each treatment cycle. Each treatment cycle lasts 4 weeks. * For the first four weeks of treatment, the participant will self-administer the SOM230 twice a day by subcutaneous injection. If they tolerate the SOM230 after 4 weeks, they will switched to the long-acting SOM230 which will be administered during scheduled treatment visits once every 4 weeks. For the first two weeks after switching to the long-acting SOM230, participants will continue to self-administer the short-acting SOM230 twice a day. * RAD001 will be taken orally once every day. * On Day 1 of every cycle, a physical exam and blood tests will be performed. Following every 2 cycles of treatment an assessment of the tumor by CT scan wil be performed. * Pharmacokinetic (pK) blood samples will be taken on days 1 and 15 of cycle one. The pK samples will be taken right before the study drug is administered and then 1, 2, 3, and 5 hours later.

Conditions

• Neuroendocrine Tumor
• Carcinoid Tumor
• Pancreatic Neuroendocrine Tumor

Interventions

Type	Name	Description
DRUG	SOM230	Given subcutaneously twice a day for four weeks then given intramuscularly once every four weeks thereafter
DRUG	RAD001	Given orally once a day

Timeline

• Start date: 2008-10-01
• Primary completion: 2014-09-01
• Completion: 2015-04-01
• First posted: 2008-12-08
• Last updated: 2016-10-19

Locations

3 sites across 1 country: United States