Trial Outcomes & Findings for Fentanyl Sublingual Spray in Treating Opioid-tolerant Cancer Patients With or Without Oral Mucositis (NCT NCT00956254)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

18 participants

Primary outcome timeframe

Pre-dose to 12 hours post-dose

Results posted on

2013-09-05

Participant Flow

Participant milestones

Participant milestones
Measure	Fentanyl Sublingual Spray 100 µg Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fentanyl Sublingual Spray 100 µg n=18 Participants Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
Age Continuous	46.6 years STANDARD_DEVIATION 12.1 • n=93 Participants
Sex: Female, Male Female	10 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants

PRIMARY outcome

Timeframe: Pre-dose to 12 hours post-dose

Population: Pharmacokinetic (PK) population: All subjects who had evaluable plasma profiles to calculate reliable estimates of PK parameters and who had no major protocol deviations. One subject in the non-mucositis group self-administered a fentanyl product before receiving the study drug and was excluded from the PK population due to this protocol deviation.

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.

Outcome measures

Outcome measures
Measure	Fentanyl Sublingual Spray 100 µg - Mucositis n=9 Participants Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.	Fentanyl Sublingual Spray 100 µg - Non-mucositis n=8 Participants Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
Cmax of Fentanyl	0.67 ng/mL Standard Deviation 0.60	0.26 ng/mL Standard Deviation 0.15

SECONDARY outcome

Timeframe: Pre-dose to 12 hours post-dose

Population: Pharmacokinetic (PK) population: All subjects who had evaluable plasma profiles to calculate reliable estimates of PK parameters and who had no major protocol deviations. One subject in the non-mucositis group self-administered a fentanyl product before receiving the study drug and was excluded from the PK population due to this protocol deviation.

Tmax is defined as the time to reach the maximum concentration of fentanyl in plasma and was determined from individual concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; and 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.

Outcome measures

Outcome measures
Measure	Fentanyl Sublingual Spray 100 µg - Mucositis n=9 Participants Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.	Fentanyl Sublingual Spray 100 µg - Non-mucositis n=8 Participants Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
Tmax of Fentanyl	0.53 hr Standard Deviation 0.57	0.56 hr Standard Deviation 0.59

SECONDARY outcome

Timeframe: Pre-dose to 12 hours post-dose

Population: Pharmacokinetic evaluable population: All subjects who had evaluable plasma profiles to calculate reliable estimates of pharmacokinetic parameters and who had no major protocol deviations.

AUC0-last is defined as the area under the plasma concentration-time curve from time-zero to the time of the last quantifiable concentration of fentanyl, was calculated using the linear trapezoidal rule, and was determined from individual concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; and 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.

Outcome measures

Outcome measures
Measure	Fentanyl Sublingual Spray 100 µg - Mucositis n=9 Participants Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.	Fentanyl Sublingual Spray 100 µg - Non-mucositis n=8 Participants Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
AUC0-last of Fentanyl	3.11 hr*ng/mL Standard Deviation 4.80	0.91 hr*ng/mL Standard Deviation 0.13

Adverse Events

Fentanyl Sublingual Spray 100 µg - Mucositis

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Fentanyl Sublingual Spray 100 µg - Non-mucositis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fentanyl Sublingual Spray 100 µg - Mucositis n=9 participants at risk Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.	Fentanyl Sublingual Spray 100 µg - Non-mucositis n=9 participants at risk Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
General disorders Burning sensation mucosal	22.2% 2/9 Safety population: All subjects who received study drug.	0.00% 0/9 Safety population: All subjects who received study drug.

Additional Information

Larry Dillaha, M.D., Chief Medical Officer

Insys Therapeutics, Inc.

Phone: 602 910-2617

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place