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Phase III Randomized
Study of Fentanyl Sublingual Spray for Breakthrough Cancer Pain in Patients Who are Opioid Tolerant
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Related Information Registry Information
Alternate Title
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
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Phase III | Supportive care | Active | 18 and over | INSYS-INS-05-001 INS-05-001, NCT00538850, NCT00538850 |
Objectives Primary - Determine the efficacy and safety of fentanyl sublingual (SL) spray for the treatment of breakthrough cancer pain in patients on around-the-clock opioids for their persistent cancer pain.
Secondary - Evaluate the
safety of fentanyl SL spray in these opioid-tolerant patients.
- Assess
the patient’s satisfaction with treatment medication.
Entry Criteria Disease Characteristics:
- Diagnosis of cancer
- Opioid-tolerant, defined as undergoing opioid treatment for cancer-related pain for ≥ 7 days and meeting 1 of the following criteria:
- Receiving at least 60 mg of oral morphine/day
- Receiving at least 25 mcg of transdermal fentanyl/hour
- Receiving at
least 30 mg of oxycodone/day
- Receiving at least 8 mg of oral hydromorphone/day
- Receiving an equianalgesic
dose of another opioid
- Experiences 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
- Experiences on average one to four 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 (e.g., oxycodone, hydrocodone, or codeine with
acetaminophen)
- Brain metastases allowed provided the patient has no signs or symptoms of increased intracranial pressure
Prior/Concurrent Therapy:
- At least 30 days since prior investigational study product(s)
- At least 14 days since prior monoamine oxidase inhibitors
- Medications or therapies that have been and continue to be used for a chronic disease condition
may be continued throughout the study provided the medication or therapy is stable in dose and
frequency for at least one week prior to the screening visit
- Medications used to help manage pain (e.g., bisphosphonates, steroids, or gabapentin) allowed provided the medication is stable in dose and frequency for at least one week prior to the screening visit
of the study and the dose/frequency are not anticipated to change during the study
- Short-acting commercially available fentanyl medications used to help manage breakthrough
pain (e.g., buccal fentanyl [Fentora®] or transmucosal fentanyl [Actiq®]) allowed for up to one-week prior to study entry onto the open-label
titration period, but are not allowed during the open-label titration period or double-blind
randomization period of the study
- Patients who complete the double-blind period and final visit of this study are eligible to proceed to INSYS-INS-06-007
Patient Characteristics:
- Able to evaluate pain relief, assess medication performance, convey adverse events, and record each use of the study drug or supplemental medication in an electronic diary (a caregiver may provide the patient the medication and help with the electronic diary but cannot enter information)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No intolerable side effects to opioids or fentanyl
- No 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
- No uncontrolled hypertension (systolic blood pressure [BP] > 180 mm Hg or diastolic BP > 90
mm Hg on two occasions at least six hours apart) despite antihypertensive therapy
- No hypertensive crisis within the past two years
- No recent history (within the past two years) of transient ischemic attacks, neural vascular
disease, stroke, or cerebral aneurysms
- No clinically uncontrolled sleep apnea
- No inability to assess pain or response to pain medications for any reason, including
psychiatric disorder, concurrent medical disorder, or concomitant therapy
- No painful erythema, edema, or ulcers under the tongue
Expected Enrollment 130Outcomes Primary Outcome(s)Pain relief by 30 minutes after dosing
Secondary Outcome(s)Pain relief at various time points Safety, tolerability, and acceptability
Outline This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual (SL) spray as a treatment for breakthrough cancer pain. The study medication is administered under the tongue as a simple spray and can be self-administered by patients or assisted by their caregivers. In addition, there is a questionnaire assessing satisfaction with the treatment. Patients are titrated to an effective-dose of fentanyl SL spray in the open-label titration period and then proceed to the double-blind randomized period. Patients are treated for up to a total of 6-7 weeks (including both the open-label titration and the double-blind randomized periods).
Trial Contact Information
Trial Lead Organizations InSys Therapeutics, Incorporated ![](https://webarchive.library.unt.edu/eot2008/20090511010306im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20090511010306im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20090511010306im_/http://www.cancer.gov/images/spacer.gif) | Ellen Feigal, MD, Protocol chair | ![](https://webarchive.library.unt.edu/eot2008/20090511010306im_/http://www.cancer.gov/images/spacer.gif) | | ![](https://webarchive.library.unt.edu/eot2008/20090511010306im_/http://www.cancer.gov/images/spacer.gif) | Trial Sites
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U.S.A. |
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Arizona |
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Phoenix |
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| | | | | | | | InSys Therapeutics, Incorporated |
| | Lauryann Aldon | Ph: | 800-365-9610 ext. 333 | | |
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| Email:
laldon@clinimetrics.com |
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Related Information PDQ® clinical trial INSYS-INS-06-007
Registry Information | ![](https://webarchive.library.unt.edu/eot2008/20090511010306im_/http://www.cancer.gov/images/spacer.gif) | Official Title | | A Randomized, Double-Blind, Placebo-Controlled Multi-Center
Study to Evaluate the Safety and Efficacy of Fentanyl Sublingual
Spray (Fentanyl SL Spray) for the Treatment of Breakthrough
Cancer Pain | ![](https://webarchive.library.unt.edu/eot2008/20090511010306im_/http://www.cancer.gov/images/spacer.gif) | Trial Start Date | | 2007-10-01 | ![](https://webarchive.library.unt.edu/eot2008/20090511010306im_/http://www.cancer.gov/images/spacer.gif) | Trial Completion Date | | 2008-12-31 (estimated) | ![](https://webarchive.library.unt.edu/eot2008/20090511010306im_/http://www.cancer.gov/images/spacer.gif) | Registered in ClinicalTrials.gov | | NCT00538850 | ![](https://webarchive.library.unt.edu/eot2008/20090511010306im_/http://www.cancer.gov/images/spacer.gif) | Date Submitted to PDQ | | 2007-12-04 | ![](https://webarchive.library.unt.edu/eot2008/20090511010306im_/http://www.cancer.gov/images/spacer.gif) | Information Last Verified | | 2008-10-10 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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