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

NCT00956254 | Completed Phase 3 Results

• 2 other identifiers: INS-09-011CDR0000647007
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mucositis; Pain; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

mucositis; unspecified adult solid tumor, protocol specific; pain

Outcome Measures

Primary Outcomes (1)

• Cmax of Fentanyl

  Cmax is defined as the maximum drug concentration in plasma and was determined from individual plasma concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; 15 and 30 minutes; and 1, 2, 4, 6, 8, 10, and 12 hours post-dose. Fentanyl concentration assays were performed using a fully validated and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Results are reported for patients with and without mucositis.

  Pre-dose to 12 hours post-dose

Secondary Outcomes (2)

• Tmax of Fentanyl

  Pre-dose to 12 hours post-dose

• AUC0-last of Fentanyl

  Pre-dose to 12 hours post-dose

Study Arms (1)

Fentanyl sublingual spray 100 µg

EXPERIMENTAL

Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.

Drug: Fentanyl sublingual spray

Interventions

Fentanyl sublingual spray DRUG

Fentanyl was supplied in single-dose glass vials assembled into a delivery device to be used as a sublingual spray.

Fentanyl sublingual spray 100 µg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• INSYS Therapeutics Inc: lead

Study Sites (1)

InSys Therapeutics, Incorporated

Scottsdale, Arizona, 85258, United States

Location

MeSH Terms

Conditions

Mucositis; Pain

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Larry Dillaha, M.D., Chief Medical Officer
• Organization: Insys Therapeutics, Inc.

ldillaha@insysrx.com

602 910-2617

Study Officials

• Lisa J. Stearns, MD

  Center for Pain and Supportive Care, PLLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2009
• First Posted: August 11, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: September 5, 2013
• Results First Posted: September 5, 2013

Record last verified: 2013-06

Locations

US (1)