Long-term Safety and Efficacy Study of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain

NCT00538863 | Completed Phase 3 Results

• 1 other identifier: INS-06-007
• Study Type: interventional
• Target: 319
• Locations: 3 countries
• Sites: 52

Brief Summary

The purpose of this study was to assess the 90-day safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain in subjects on around-the-clock opioids for their persistent cancer pain.

Conditions

Cancer; Pain

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients That Experienced 1 or More Adverse Events

  Baseline to end of the study (up to 116 days)

Study Arms (2)

Fentanyl sublingual spray titration

EXPERIMENTAL

Patients received fentanyl sublingual spray to treat up to a maximum of 4 breakthrough pain episodes per day with a minimum separation of 4 hours between treatments. Patients started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 26 days was reached.

Drug: Fentanyl sublingual spray

Fentanyl sublingual spray maintenance

EXPERIMENTAL

Patients received fentanyl sublingual spray up to a maximum of 4 times per day with a minimum separation of 4 hours between treatments for 90 days. Patients received a dose of 100 to 1600 µg determined in a previous study (INS-05-001, NCT00538850) or in the open-label dose titration period of the current study. The dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects.

Drug: Fentanyl sublingual spray

Interventions

Fentanyl sublingual spray DRUG

Fentanyl sublingual spray in doses of 100, 200, 400, 600, 800, 1200, and 1600 µg

Fentanyl sublingual spray maintenance; Fentanyl sublingual spray titration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects who have completed the Double-blind Period and Final Visit of protocol INS-05-001(NCT00538850), Multicenter Randomized Double-blind Trial of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain are eligible for participation in this open-label extension study.
• All de novo subjects must meet all of the following criteria to be eligible for participation in the study:
• Male or female, \> 18 years of age.
• Diagnosis of cancer.
• Opioid treatment. Patients who are treated with opioids are defined as those patients who are taking at least 60 mg of oral morphine/day, at least 25 µg of transdermal fentanyl/hour, at least 30 mg of oxycodone/day, at least 8 mg of oral hydromorphone/day or an equianalgesic dose of another opioid for \> 7 days for cancer-related pain.
• Experience persistent pain related to the cancer or its treatment of moderate or lesser intensity in the 24 hours prior to assessment by a verbal rating scale at the Screening Visit.
• Experience on average 1 to 4 breakthrough cancer pain episodes per day usually at least partially controlled by supplemental medication of at least 5 mg immediate-release morphine or an equivalent short-acting opioid (eg, oxycodone, hydrocodone, or codeine with acetaminophen).
• Able to evaluate pain relief, assess medication performance, report adverse events (AEs), report use of the study drug or supplemental medication (a caregiver may provide the subject the medication).
• Able and willing to give informed consent.
• Women of childbearing potential must have a) a negative urine pregnancy test, b) not be breast feeding and c) agree to practice a reliable form of contraception.

You may not qualify if:

• Intolerable side effects to opioids or fentanyl.
• Rapidly increasing/uncontrolled pain.
• A history of major organ system impairment or disease, that in the Investigator's or his/her designee's opinion could increase the risk associated with the use of opioids.
• Uncontrolled hypertension (systolic blood pressure \[BP\] \> 180 mm Hg or diastolic BP \> 90 mm Hg on 2 occasions at least 6 hours apart) despite antihypertensive therapy, or has a history of hypertensive crisis within the past 2 years.
• A recent history (within the past 2 years) of transient ischemic attacks, neural vascular disease, stroke, or cerebral aneurysms.
• Serum creatinine, ALT or AST that is greater than 3 times the upper limit of normal.
• Diagnosis of sleep apnea.
• Brain metastases with signs or symptoms of increased intracranial pressure.
• Inability to assess pain or response to pain medications for any reason, including psychiatric disorder, concurrent medical disorder, or concomitant therapy.
• Has used methadone within 14 days of the Screening Visit.
• Received an investigational study product(s) within 30 days of the Screening Visit.
• Use of monoamine oxidase (MAO) inhibitors within 14 days of the Screening Visit.

Sponsors & Collaborators

• INSYS Therapeutics Inc: lead

Study Sites (52)

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Huntsville, Alabama, United States

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Winfield, Alabama, United States

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Glendale, Arizona, United States

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Scottsdale, Arizona, United States

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Laguna Hills, California, United States

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Loma Linda, California, United States

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Los Gatos, California, United States

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San Mateo, California, United States

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Bradenton, Florida, United States

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Lake Worth, Florida, United States

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Miami, Florida, United States

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Winter Park, Florida, United States

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Newnan, Georgia, United States

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Chicago, Illinois, United States

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Skokie, Illinois, United States

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Zion, Illinois, United States

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Elkhart, Indiana, United States

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Bethesda, Maryland, United States

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Southfield, Michigan, United States

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Edina, Minnesota, United States

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Jefferson City, Missouri, United States

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Great Falls, Montana, United States

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Kalispell, Montana, United States

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Missoula, Montana, United States

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Voorhees Township, New Jersey, United States

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Flat Rock, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Canton, Ohio, United States

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Dayton, Ohio, United States

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Eugene, Oregon, United States

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Altoona, Pennsylvania, United States

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Danville, Pennsylvania, United States

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Lemoyne, Pennsylvania, United States

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Kingsport, Tennessee, United States

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Bellaire, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Port Sam Houston, Texas, United States

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Tacoma, Washington, United States

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Appleton, Wisconsin, United States

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Oakville, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Ahmedabad, India, India

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Bangalore, India, India

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Bhopal, India, India

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Hyderabad, India, India

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Jaipur, India, India

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Mumbai, India, India

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Nashik, India, India

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Pune, India, India

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MeSH Terms

Conditions

Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Larry Dillaha, M.D., Chief Medical Officer
• Organization: Insys Therapeutics, Inc.

ldillaha@insysrx.com

602-910-2617

Study Officials

• Larry Dillaha, MD

  Chief Medical Officer, Insys Therapeutics Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2007
• First Posted: October 3, 2007
• Study Start: December 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 11, 2013
• Results First Posted: October 11, 2013

Record last verified: 2013-08

Locations

CA (4); IN (8); US (40)