Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Not Enrolling
Both
Mucositis, Pain, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Safety variables

Safety Issue:

Yes

Principal Investigator

Lisa J. Stearns, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Center for Pain and Supportive Care, PLLC

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000647007

NCT ID:

NCT00956254

Start Date:

June 2009

Completion Date:

Related Keywords:

  • Mucositis
  • Pain
  • Unspecified Adult Solid Tumor, Protocol Specific
  • mucositis
  • unspecified adult solid tumor, protocol specific
  • pain
  • Stomatitis
  • Mucositis

Name

Location

InSys Therapeutics, IncorporatedScottsdale, Arizona  85258