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

Condition(s) targeted: Mucositis; Pain; Unspecified Adult Solid Tumor, Protocol Specific

Intervention: fentanyl sublingual spray (Drug); laboratory biomarker analysis (Other); pharmacological study (Other)

Phase: Phase 3

Status: Recruiting

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

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.

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: Supportive Care, Open Label

Primary outcome:

Safety variables

Absorption/distribution kinetics

Pharmacokinetics in patients with and without mucositis

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.

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

InSys Therapeutics, Incorporated, Scottsdale, Arizona 85258, United States; Recruiting
Lisa J. Stearns, MD, Phone: 480-889-0180

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: June 2009
Last updated: August 8, 2009