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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00956254
First received: August 8, 2009
Last updated: November 4, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Mucositis
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Drug: fentanyl sublingual spray
Other: laboratory biomarker analysis
Other: pharmacological study
Phase 3

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety variables [ Designated as safety issue: Yes ]
  • Absorption/distribution kinetics [ Designated as safety issue: No ]
  • Pharmacokinetics in patients with and without mucositis [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2009
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00956254

Locations
United States, Arizona
InSys Therapeutics, Incorporated
Scottsdale, Arizona, United States, 85258
Sponsors and Collaborators
Insys Therapeutics Inc
Investigators
Principal Investigator: Lisa J. Stearns, MD Center for Pain and Supportive Care, PLLC
  More Information

Additional Information:
No publications provided

Responsible Party: Regulatory Affairs Associate, InSys Therapeutics, Incorporated
ClinicalTrials.gov Identifier: NCT00956254     History of Changes
Other Study ID Numbers: CDR0000647007, INSYS-INS-09-011
Study First Received: August 8, 2009
Last Updated: November 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
mucositis
unspecified adult solid tumor, protocol specific
pain

Additional relevant MeSH terms:
Stomatitis
Mucositis
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 23, 2013