NCT00576680

RAD001 and Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors

Phase I/II Study of RAD001 in Combination With Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study will test the safety of RAD001 in combination with temozolomide.

Detailed description

* Participants will take RAD001 by mouth daily. They will also take temozolomide by mouth daily for one week, followed by a one-week break period. This one-week on/one week off schedule for temozolomide will continue for the duration of the treatment. * After the first month of treatment, there will be a 7-day observation period during which no study medication will be taken to observe for any side effects. * During all treatment cycles (1 cycle is 28 days in length) participants will have a physical exam and will be asked questions about their general health and specific questions about any problems they may be experiencing. Initially, participants will come in every other week. At each of these visits, blood work will be taken to monitor the participants health. * After every 2 months of treatment, participants will have a CT scan or MRI done to see how the medication is working.

Conditions

• Pancreatic Neuroendocrine Tumor

Interventions

Type	Name	Description
DRUG	RAD001	Given orally once a day
DRUG	Temozolomide	Taken orally once a day for one week followed by a one-week break period

Timeline

• Start date: 2008-05-01
• Primary completion: 2019-03-29
• Completion: 2019-03-29
• First posted: 2007-12-19
• Last updated: 2020-07-09
• Results posted: 2020-07-09

Locations

3 sites across 1 country: United States