Fentanyl Sublingual Spray in Treating Opioid-tolerant Cancer Patients With or Without Oral Mucositis
Information source: INSYS Therapeutics Inc
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mucositis; Pain; Unspecified Adult Solid Tumor, Protocol Specific
Intervention: Fentanyl sublingual spray (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: INSYS Therapeutics Inc Official(s) and/or principal investigator(s): Lisa J. Stearns, MD, Principal Investigator, Affiliation: Center for Pain and Supportive Care, PLLC
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.
Clinical Details
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 design: Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: Cmax of Fentanyl
Secondary outcome: Tmax of FentanylAUC0-last of Fentanyl
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
InSys Therapeutics, Incorporated, Scottsdale, Arizona 85258, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: October 2009
Last updated: June 25, 2013
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