Fentanyl Sublingual Spray in Treating Opioid-Tolerant Cancer Patients With or Without Oral Mucositis
This study has been completed.
Sponsor:
Insys Therapeutics Inc
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
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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) |
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