Trial Outcomes & Findings for Lazanda in Cancer Patients Receiving Palliative Radiation (NCT NCT03071744)

Last Updated: 2019-12-09

Results Overview

Assess the change in patient reported positional pain intensity (PI) as measured by an 11-point numerical rating scale zero (no pain) to ten (severe pain) (NRS-11; scores on a scale) in cancer patients with bone metastases assessed at each daily palliative radiation fraction. Our primary objective will be measured using the pain intensity difference (PID) of the NRS-11 between 0 minutes and 15 minutes after laying down on the hard surface (PID15= PI0- PI15).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

0 minutes and 15 minutes after laying down on the hard surface (PID15= PI0- PI15).

Results posted on

2019-12-09

Participant Flow

Participant milestones

Participant milestones
Measure	Lazanda Study drug, Lazanda, will be self-administered intranasally during this study. The dose of Lazanda is not predicted from the daily maintenance dose of opioid used to manage persistent cancer pain and must be determined by dose titration. The minimal effective intranasal dose from the radiation therapy simulation will be the dose used as pre-medication prior to any further radiation therapy fractions (up to 10 fractions). Lazanda should be administered 15 (T-15) minutes prior to laying on the hard surface for each simulation visit. If the response to the titrated Lazanda dose markedly changes, an adjustment of dose may be necessary to ensure that an appropriate dose is maintained as deemed by the investigator. Lazanda: Lazanda is supplied in glass bottles, containing 8 sprays of 100 mcL containing 100 mcg/100 mcL or 400 mcg/100 mcL concentration solution.
Overall Study STARTED	6
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lazanda in Cancer Patients Receiving Palliative Radiation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lazanda n=6 Participants Study drug, Lazanda, will be self-administered intranasally during this study. The dose of Lazanda is not predicted from the daily maintenance dose of opioid used to manage persistent cancer pain and must be determined by dose titration. The minimal effective intranasal dose from the radiation therapy simulation will be the dose used as pre-medication prior to any further radiation therapy fractions (up to 10 fractions). Lazanda should be administered 15 (T-15) minutes prior to laying on the hard surface for each simulation visit. If the response to the titrated Lazanda dose markedly changes, an adjustment of dose may be necessary to ensure that an appropriate dose is maintained as deemed by the investigator. Lazanda: Lazanda is supplied in glass bottles, containing 8 sprays of 100 mcL containing 100 mcg/100 mcL or 400 mcg/100 mcL concentration solution.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0 minutes and 15 minutes after laying down on the hard surface (PID15= PI0- PI15).

Outcome measures

Outcome measures
Measure	Lazanda n=6 Participants Study drug, Lazanda, will be self-administered intranasally during this study. The dose of Lazanda is not predicted from the daily maintenance dose of opioid used to manage persistent cancer pain and must be determined by dose titration. The minimal effective intranasal dose from the radiation therapy simulation will be the dose used as pre-medication prior to any further radiation therapy fractions (up to 10 fractions). Lazanda should be administered 15 (T-15) minutes prior to laying on the hard surface for each simulation visit. If the response to the titrated Lazanda dose markedly changes, an adjustment of dose may be necessary to ensure that an appropriate dose is maintained as deemed by the investigator. Lazanda: Lazanda is supplied in glass bottles, containing 8 sprays of 100 mcL containing 100 mcg/100 mcL or 400 mcg/100 mcL concentration solution.
Number of Participants With Change in Patient Reported Positional Pain Intensity	4 Participants

SECONDARY outcome

Timeframe: from the time of laying down on the hard surface (0 minutes) to 15 minutes after laying down at each fractionation visit.

Assess change in patient reported pain severity using the Brief Pain Inventory Short Form (BPI-sf).

Outcome measures

Outcome measures
Measure	Lazanda n=4 Participants Study drug, Lazanda, will be self-administered intranasally during this study. The dose of Lazanda is not predicted from the daily maintenance dose of opioid used to manage persistent cancer pain and must be determined by dose titration. The minimal effective intranasal dose from the radiation therapy simulation will be the dose used as pre-medication prior to any further radiation therapy fractions (up to 10 fractions). Lazanda should be administered 15 (T-15) minutes prior to laying on the hard surface for each simulation visit. If the response to the titrated Lazanda dose markedly changes, an adjustment of dose may be necessary to ensure that an appropriate dose is maintained as deemed by the investigator. Lazanda: Lazanda is supplied in glass bottles, containing 8 sprays of 100 mcL containing 100 mcg/100 mcL or 400 mcg/100 mcL concentration solution.
Participants With Change in Patient Reported Positional Pain Severity Via the Brief Pain Inventory Short Form	4 Participants

SECONDARY outcome

Timeframe: 4-5 weeks of patient participation in the study

evaluate adverse effects associated with Lazanda use utilizing the NCI CTCAE version 4.03 before and after palliative radiation.

Outcome measures

Outcome measures
Measure	Lazanda n=4 Participants Study drug, Lazanda, will be self-administered intranasally during this study. The dose of Lazanda is not predicted from the daily maintenance dose of opioid used to manage persistent cancer pain and must be determined by dose titration. The minimal effective intranasal dose from the radiation therapy simulation will be the dose used as pre-medication prior to any further radiation therapy fractions (up to 10 fractions). Lazanda should be administered 15 (T-15) minutes prior to laying on the hard surface for each simulation visit. If the response to the titrated Lazanda dose markedly changes, an adjustment of dose may be necessary to ensure that an appropriate dose is maintained as deemed by the investigator. Lazanda: Lazanda is supplied in glass bottles, containing 8 sprays of 100 mcL containing 100 mcg/100 mcL or 400 mcg/100 mcL concentration solution.
Number of Participants With Adverse Effects Associated With Lazanda	4 Participants

Adverse Events

Lazanda

Serious events: 1 serious events

Other events: 4 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Lazanda n=6 participants at risk Study drug, Lazanda, will be self-administered intranasally during this study. The dose of Lazanda is not predicted from the daily maintenance dose of opioid used to manage persistent cancer pain and must be determined by dose titration. The minimal effective intranasal dose from the radiation therapy simulation will be the dose used as pre-medication prior to any further radiation therapy fractions (up to 10 fractions). Lazanda should be administered 15 (T-15) minutes prior to laying on the hard surface for each simulation visit. If the response to the titrated Lazanda dose markedly changes, an adjustment of dose may be necessary to ensure that an appropriate dose is maintained as deemed by the investigator. Lazanda: Lazanda is supplied in glass bottles, containing 8 sprays of 100 mcL containing 100 mcg/100 mcL or 400 mcg/100 mcL concentration solution.
Infections and infestations Sepsis due to UTI	16.7% 1/6 • 30 days from the last study drug administration (about 2 months)

Other adverse events

Other adverse events
Measure	Lazanda n=6 participants at risk Study drug, Lazanda, will be self-administered intranasally during this study. The dose of Lazanda is not predicted from the daily maintenance dose of opioid used to manage persistent cancer pain and must be determined by dose titration. The minimal effective intranasal dose from the radiation therapy simulation will be the dose used as pre-medication prior to any further radiation therapy fractions (up to 10 fractions). Lazanda should be administered 15 (T-15) minutes prior to laying on the hard surface for each simulation visit. If the response to the titrated Lazanda dose markedly changes, an adjustment of dose may be necessary to ensure that an appropriate dose is maintained as deemed by the investigator. Lazanda: Lazanda is supplied in glass bottles, containing 8 sprays of 100 mcL containing 100 mcg/100 mcL or 400 mcg/100 mcL concentration solution.
Gastrointestinal disorders Dry Heaves	16.7% 1/6 • 30 days from the last study drug administration (about 2 months)
Musculoskeletal and connective tissue disorders Malaise - aches /pain	16.7% 1/6 • 30 days from the last study drug administration (about 2 months)
Immune system disorders Flu Symptoms	16.7% 1/6 • 30 days from the last study drug administration (about 2 months)
Musculoskeletal and connective tissue disorders Severe leg pain	16.7% 1/6 • 30 days from the last study drug administration (about 2 months)
Skin and subcutaneous tissue disorders Dry mouth	16.7% 1/6 • 30 days from the last study drug administration (about 2 months)
Renal and urinary disorders Creatinine increase	16.7% 1/6 • 30 days from the last study drug administration (about 2 months)

Additional Information

Eric Roeland, MD

UCSD

Phone: (858) 534-7079

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place