Lazanda in Cancer Patients Receiving Palliative Radiation

NCT03071744 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: UCSD 161263
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Advanced cancer patients often require palliative (pain relieving) radiotherapy to treat cancer-related symptoms. The delivery of radiation requires patients to lie still on a hard flat surface, which can result in significant acute (intense) pain and/or breakthrough cancer pain (sudden sharp or stabbing pain), especially when painful bone metastases are present. The current care for most cancer patients receiving radiation is to take an oral (by mouth) opioid medication before the radiation treatment. The pain relieving effects of these medications can take about one hour and can last for 3 to 6 hours, which does not follow the time course of when breakthrough cancer pain occurs. Lazanda is a pain medication delivered via an intranasal route and is already approved by the U.S. Food and Drug Administration (FDA) for the management of breakthrough cancer pain for patients who are already receiving opioids and who can tolerate opioids for the treatment of cancer pain. Lazanda is fast-acting and convenient for patients to take. The purpose of this study is to assess the change in pain intensity during palliative radiotherapy following study treatment with Lazanda. This study will also explore the impact of the study treatment on the efficiency in delivering the radiation therapy

Conditions

Bone Metastases

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Change in Patient Reported Positional Pain Intensity

  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).

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

Secondary Outcomes (2)

• Participants With Change in Patient Reported Positional Pain Severity Via the Brief Pain Inventory Short Form

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

• Number of Participants With Adverse Effects Associated With Lazanda

  4-5 weeks of patient participation in the study

Study Arms (1)

Lazanda

OTHER

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.

Drug: Lazanda

Interventions

Lazanda DRUG

Lazanda is supplied in glass bottles, containing 8 sprays of 100 mcL containing 100 mcg/100 mcL or 400 mcg/100 mcL concentration solution.

Also known as: Fentanyl

Lazanda

Eligibility Criteria

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

You may qualify if:

• Patient has the ability to understand and the willingness to sign a written informed consent.
• Pathologically-confirmed solid tumor or hematologic malignancy with symptomatic bone metastases.
• Patient is planned to receive hypofractionated palliative radiation ≤ 10 fractions.
• Patient must be opioid-tolerant (greater than or equal to 60mg morphine or equivalent) and on a stable dose of oral opioids for greater than or equal to 1 week. Stable baseline opioid dosage defined as a dosage that does not fluctuate by more than 50% from the average dosage over one week prior to screening.
• Patient must be on a stable dose of adjuvant pain therapies for one week prior to screening (i.e. steroids, NSAIDs, anticonvulsants, pharmaceutical cannabinoids, tricyclic antidepressants).
• Patient is ≥ 18 years of age.
• Both men and women of all races and ethnic groups are eligible for this trial.
• ECOG Performance Status ≤ 3
• Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 28 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)Women of child-bearing potential has negative pregnancy test prior to initiating study drug dosing.

You may not qualify if:

• Patient is currently receiving or has received another investigational agent within 30 days or monoamine oxidase inhibitor within 14 days prior to Lazanda administration.
• Patients who require immobilization with a thermoplastic mask for radiation treatment.
• Patient is planned to receive interventional procedures (i.e. surgery) that may affect study outcomes.
• Patient has a history of hypersensitivity to fentanyl or opioids.
• Patient is pregnant or nursing. There is a potential for congenital abnormalities and for this regimen to harm nursing infants.
• Patient is being treated with oxymetazoline for allergic rhinitis or has a disorder or current medication use likely to adversely affect normal functioning of the nasal mucosa.
• Patient has uncontrolled or rapidly escalating background pain.
• Patient has bradyarrhythmia.
• Patient is considered medically unstable.
• Patient is thought to be at risk for misuse, abuse, addiction or overdose for Schedule II controlled substance, as evidenced by the following:
• An Opioid Risk Tool (ORT) score of greater/less than or equal to 8.
• A review of the California Prescription Control Monitoring Program (PDMP) Controlled Substance Utilization Review and Evaluation System (CURES) report demonstrates multiple prescribing providers and/or multiple pharmacies in the last 30 days. The CURES report will also be used to verify opioid use, opioid dose, and current prescribing providers.

Sponsors & Collaborators

• Joseph Ma: lead

Study Sites (1)

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Eric Roeland, MD
• Organization: UCSD

eroeland@ucsd.edu

(858) 534-7079

Study Officials

• Joseph Ma, PharmD

  UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 7, 2017
• Study Start: March 1, 2017
• Primary Completion: March 9, 2018
• Study Completion: March 9, 2018
• Last Updated: December 9, 2019
• Results First Posted: July 23, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)