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

Primary Purpose

Mucositis, Pain, Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Fentanyl sublingual spray
Sponsored by
INSYS Therapeutics Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mucositis focused on measuring mucositis, unspecified adult solid tumor, protocol specific, pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • InSys Therapeutics, Incorporated

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fentanyl sublingual spray 100 µg

Arm Description

Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.

Outcomes

Primary Outcome Measures

Cmax of Fentanyl
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

Tmax of Fentanyl
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.
AUC0-last of Fentanyl
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.

Full Information

First Posted
August 8, 2009
Last Updated
June 25, 2013
Sponsor
INSYS Therapeutics Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00956254
Brief Title
Fentanyl Sublingual Spray in Treating Opioid-tolerant Cancer Patients With or Without Oral Mucositis
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 Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
INSYS Therapeutics Inc

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis, Pain, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
mucositis, unspecified adult solid tumor, protocol specific, pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fentanyl sublingual spray 100 µg
Arm Type
Experimental
Arm Description
Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
Intervention Type
Drug
Intervention Name(s)
Fentanyl sublingual spray
Intervention Description
Fentanyl was supplied in single-dose glass vials assembled into a delivery device to be used as a sublingual spray.
Primary Outcome Measure Information:
Title
Cmax of Fentanyl
Description
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.
Time Frame
Pre-dose to 12 hours post-dose
Secondary Outcome Measure Information:
Title
Tmax of Fentanyl
Description
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.
Time Frame
Pre-dose to 12 hours post-dose
Title
AUC0-last of Fentanyl
Description
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.
Time Frame
Pre-dose to 12 hours post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa J. Stearns, MD
Organizational Affiliation
Center for Pain and Supportive Care, PLLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
InSys Therapeutics, Incorporated
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States

12. IPD Sharing Statement

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

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