Fentanyl Sublingual Spray in Treating Opioid-Tolerant Cancer Patients With or Without Oral Mucositis
RATIONALE: One dose of fentanyl sublingual spray may be effective in relieving pain in opioid-tolerant cancer patients.
PURPOSE: This phase III trial is studying the side effects of fentanyl sublingual spray and to see how well it works in treating opioid-tolerant cancer patients with or without oral mucositis.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: fentanyl sublingual spray
Other: laboratory biomarker analysis
Other: pharmacological study
|Study Design:||Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Evaluate Safety and Tolerability and Compare Absorption/Distribution Kinetics of a Single 100 Mcg Dose of Fentanyl Sublingual Spray (Fentanyl SL Spray) in Cancer Subjects With or Without Oral Mucositis|
- Safety variables [ Designated as safety issue: Yes ]
- Absorption/distribution kinetics [ Designated as safety issue: No ]
- Pharmacokinetics in patients with and without mucositis [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
- To compare the absorption/distribution kinetics of a single dose of fentanyl sublingual spray in opioid-tolerant cancer patients with or without oral mucositis.
- To evaluate the safety and tolerability of this regimen.
OUTLINE: This is a multicenter study.
Patients fast for at least 8 hours before and at least 4 hours after and no water is allowed for at least 1 hour before and at least 1 hour after study drug administration. Patients receive a single dose of fentanyl sublingual spray while in an upright position in clinical care recliners or beds, and remain in an upright posture for at least 4 hours after administration. Patients are instructed not to swallow for at least 5 minutes after administration and not to expectorate the drug.
After study drug administration, 10 blood samples are collected over a 12-hour period for pharmacokinetic and other analyses.
|United States, Arizona|
|InSys Therapeutics, Incorporated|
|Scottsdale, Arizona, United States, 85258|
|Principal Investigator:||Lisa J. Stearns, MD||Center for Pain and Supportive Care, PLLC|