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

Sponsor:	Insys Therapeutics Inc
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00956254

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 III

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:

MedlinePlus related topics: Cancer

Drug Information available for: Fentanyl Fentanyl Citrate

U.S. FDA Resources

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
Estimated Primary Completion Date:	June 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	Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Lisa J. Stearns, MD 480-889-0180

Sponsors and Collaborators

Insys Therapeutics Inc

Investigators

Principal Investigator:

Lisa J. Stearns, MD

Center for Pain and Supportive Care, PLLC

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	InSys Therapeutics, Incorporated ( Regulatory Affairs Associate )
Study ID Numbers:	CDR0000647007, INSYS-INS-09-011
Study First Received:	August 8, 2009
Last Updated:	August 8, 2009
ClinicalTrials.gov Identifier:	NCT00956254 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

mucositis
unspecified adult solid tumor, protocol specific
pain

Additional relevant MeSH terms:

Anesthetics, Intravenous
Mouth Diseases
Fentanyl
Mucositis
Stomatitis
Gastrointestinal Diseases
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Pharmacologic Actions

Adjuvants, Anesthesia
Digestive System Diseases
Anesthetics, General
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Stomatognathic Diseases
Gastroenteritis
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on March 18, 2010