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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Related Information
Registry Information

Alternate Title

Phase III Study of Fentanyl Sublingual Spray for Breakthrough Cancer Pain in Patients Who are Opioid Tolerant

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Active	18 and over	Pharmaceutical / Industry	INSYS-INS-06-007 INS-06-007, NCT00538863

Trial Description

Purpose:

Fentanyl sublingual spray may help relieve breakthrough pain in patients receiving opioids for cancer pain.

This phase III trial is studying how well fentanyl sublingual spray works in treating patients with breakthrough cancer pain.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Receiving morphine, fentanyl, oxycodone, hydromorphone, or another opioid for at least a week for cancer pain OR was previously treated on clinical trial INSYS-INS-05-001
• Has an average of one to four breakthrough cancer pain episodes each day (for patients who have not been treated on clinical trial INSYS-INS-05-001)
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive fentanyl sublingual spray for up to 17 weeks. They will also fill out questionnaires.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

InSys Therapeutics, Incorporated

Ellen Feigal, MD, Protocol chair		Ph: 602-910-2617

U.S.A.
Arizona
	Phoenix
	InSys Therapeutics, Incorporated
		Lauryann Aldon	Ph:  602-910-2617 800-365-9610 ext. 333

Related Information

PDQ® clinical trial INSYS-INS-05-001

Registry Information
Official Title		Open-label Multi-center Safety Trial of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breakthrough Cancer Pain
Trial Start Date		2007-11-01
Trial Completion Date		2009-03-01 (estimated)
Registered in ClinicalTrials.gov		NCT00538863
Date Submitted to PDQ		2008-01-04
Information Last Verified		2008-10-24