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Fentanyl Sublingual Spray in Treating Opioid-tolerant Cancer Patients With or Without Oral Mucositis

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ClinicalTrials.gov Identifier: NCT00956254
Recruitment Status : Completed
First Posted : August 11, 2009
Results First Posted : September 5, 2013
Last Update Posted : September 5, 2013
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Study Description
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Brief Summary:
This was an open-label, single-dose study to assess the safety, tolerability, and absorption/distribution kinetics of a single 100 µg dose of fentanyl sublingual spray in opioid-tolerant cancer subjects, with or without oral mucositis.

Condition or disease Intervention/treatment Phase
Mucositis Pain Unspecified Adult Solid Tumor, Protocol Specific Drug: Fentanyl sublingual spray Phase 3

Detailed Description:

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.

OBJECTIVES:

Primary

  • 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Fentanyl sublingual spray 100 µg
Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
 Drug: Fentanyl sublingual spray
Fentanyl was supplied in single-dose glass vials assembled into a delivery device to be used as a sublingual spray.


Outcome Measures
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Primary Outcome Measures :
  1. Cmax of Fentanyl [ Time Frame: Pre-dose to 12 hours post-dose ]
    Cmax is defined as the maximum drug concentration in plasma and was determined from individual plasma concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; 15 and 30 minutes; and 1, 2, 4, 6, 8, 10, and 12 hours post-dose. Fentanyl concentration assays were performed using a fully validated and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Results are reported for patients with and without mucositis.


Secondary Outcome Measures :
  1. Tmax of Fentanyl [ Time Frame: Pre-dose to 12 hours post-dose ]
    Tmax is defined as the time to reach the maximum concentration of fentanyl in plasma and was determined from individual concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; and 15 and 30 minutes; and 1, 2, 4, 6, 8, 10, and 12 hours post-dose. Fentanyl concentration assays were performed using a fully validated and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Results are reported for patients with and without mucositis.

  2. AUC0-last of Fentanyl [ Time Frame: Pre-dose to 12 hours post-dose ]
    AUC0-last is defined as the area under the plasma concentration-time curve from time-zero to the time of the last quantifiable concentration of fentanyl, was calculated using the linear trapezoidal rule, and was determined from individual concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; and 15 and 30 minutes; and 1, 2, 4, 6, 8, 10, and 12 hours post-dose. Fentanyl concentration assays were performed using a fully validated and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Results are reported for patients with and without mucositis.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer and meets 1 of the following criteria:

    • Mild mucositis, defined as grade 1 (erythema of the mucosa) or 2 (patchy ulcerations or pseudomembranes) on the day of study drug administration.
    • No mucositis, defined as normal oral cavity upon examination on the day of study drug administration.
  • Opioid-tolerant, defined as patients who are taking ≥ 60 mg of oral morphine/day, ≥ 30 mg of oxycodone/day, ≥ 8 mg of oral hydromorphone/day, or an equianalgesic dose of another opioid for ≥ 7 days for cancer-related pain.
  • Persistent pain related to cancer or its treatment over the past 7 days.
  • No brain metastases with signs or symptoms of increased intracranial pressure.

PATIENT CHARACTERISTICS:

  • Negative pregnancy test.
  • Agree to be confined to study site for approximately 12 hours, to eat only the food served by the study unit during the study confinement period, and to consume all food provided at the designated meal or snack times.
  • 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 despite antihypertensive therapy or history of hypertensive crisis within the past 2 years.
  • No recent history (within the past 2 years) of transient ischemic attacks, neural vascular disease, stroke, or cerebral aneurysms.
  • No intolerable side effects to opioids or fentanyl.

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics.
  • More than 30 days since prior investigational agents.
  • More than 14 days since prior monoamine oxidase inhibitors.
  • No prior participation in either Insys Fentanyl Sublingual Spray Phase III study INSYS-INS-05-001 or INSYS-INS-06-007.

  • No other concurrent use of any fentanyl product.

    • Patients who have received Actiq®, Fentora®, or Duragesic® are eligible after a 7-day washout.
  • No concurrent medications (prescription, over-the-counter, vitamin, or herbal substances) except for hormonal contraceptives and/or ≤ 3 doses of acetaminophen at ≤ 1 g each.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956254


Locations
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United States, Arizona
InSys Therapeutics, Incorporated
Scottsdale, Arizona, United States, 85258
Sponsors and Collaborators
INSYS Therapeutics Inc
Investigators
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Principal Investigator: Lisa J. Stearns, MD Center for Pain and Supportive Care, PLLC
More Information
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Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT00956254    
Other Study ID Numbers: INS-09-011
CDR0000647007 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: August 11, 2009    Key Record Dates
Results First Posted: September 5, 2013
Last Update Posted: September 5, 2013
Last Verified: June 2013
Keywords provided by INSYS Therapeutics Inc:
mucositis
unspecified adult solid tumor, protocol specific
pain
Additional relevant MeSH terms:
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Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Fentanyl
Analgesics, Opioid
Narcotics
 Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics