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

Lazanda

Joseph Ma, PharmD

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

This is a Phase II, single-center, single-arm, Open-Label Study to Evaluate Lazanda in Cancer Patients Receiving Palliative Radiation.

The primary objective of this study is to assess the change in patient reported positional pain intensity (PI) as measured by an 11-point numerical rating scale (NRS-11) in cancer patients with bone metastases assessed at a simulation visit and each subsequent daily palliative radiation fraction. The primary objective will be measured using the pain intensity difference (PID) of the NRS-11 from the time of laying down on the hard surface (0 minutes/ PI0) to the 15 minutes after laying down on the hard surface timepoint at baseline (the simulation visit) and at each subsequent study visit (PID15= PI0- PI15).

Study participants will be recruited across all oncology disease teams. Potential participants will be identified in weekly palliative care or disease team patient triage meetings. In order to meet eligibility for participation, a patient must be greater than or equal to 18 years old, have histologically-confirmed cancer with symptomatic bone metastases, an Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3, and are planned to receive hypofractionated palliative radiation less than or equal to 10 fractions. Qualifying subjects must be opioid-tolerant, defined as greater than or equal to 60mg morphine or equivalent, and be on a stable dose of oral opioids for greater than or equal to 1 week. Stable baseline opioid dosage is defined as a dosage that does not fluctuate by more than 50% from the average dosage over one week prior to screening. Patients must also be on a stable dose of adjuvant pain therapies for one week prior to screening. Patients will be excluded if they are receiving or have received another investigational agent within 30 days or monoamine oxidase inhibitor within 14 days prior to Lazanda administration, have known hypersensitivity to fentanyl or opioids, have known, planned interventional procedures such as surgery that may affect study outcomes, are pregnant or nursing, have a disorder or current medication use likely to adversely affect normal functioning of the nasal mucosa, have uncontrolled or rapidly escalating background pain, or are medically unstable, require immobilization with a thermoplastic mask for radiation treatment.

Upon confirmation of all eligibility criteria, the subject will be enrolled. Each enrolled subject will undergo a baseline evaluation on a mock hard surface within 1 week prior to the time of CT simulation, to establish baseline NRS pain scores.

Subject will receive Lazanda at their mock hard surface visit , radiation simulation visit and again as pre-medication prior to each radiation treatment (fraction), for an estimated treatment period of 10 days based on the patient's radiation treatment plan. Lazanda will be self-administered intranasally by subjects participating in this study.

NRS pain scores will be collected at three time points at baseline : 15 minutes prior to laying on the hard surface (T-15), at the time of laying on the hard surface (T0), and at 15 minutes after laying on the hard surface(T+15). Exact time of each pain score rating will also be collected.

After the mock visit subject will then undergo radiation therapy simulation procedures (within approximately 2 weeks of radiation therapy) followed by hypofractionated radiation therapy, according to University of California, San Diego (UCSD) Radiation Oncology standard procedure and treatment plan determined by the subject's radiation oncologist. During radiation simulation and daily during each visit to the radiation center for hypofractionation delivery, subjects will have vital signs and weight collected. An ECOG performance status will also be assessed daily during radiation therapy. At the time of radiation simulation and daily during radiation therapy, subjects will complete the BPI-sf , Medication Use Diary, Laxation Diary, and Nausea/Vomiting Diary. As with the mock hard surface evaluation, NRS pain scores will also be collected at three time points during each visit to the radiation center.

Subjects will receive study drug, Lazanda at 100mcg dose, 15 minutes prior to simulation (T-15) at the radiation therapy simulation visit. Lazanda dose titration will follow the guidelines as indicated in the product package insert from the radiation simulation visit through the end of radiation therapy.

Subjects will undergo a post treatment follow-up period after completion of their radiation therapy. During this follow-up period, subjects will complete the BPI-sf, Medication Use Diary, Laxation Diary , and Nausea/Vomiting Diary daily for 2 days.

Lazanda in Cancer Patients Receiving Palliative Radiation

Phase II, Open-Label Study to Evaluate Lazanda in Cancer Patients Receiving Palliative Radiation

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).

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

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

Joseph Ma

Associate Clinical Professor

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

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Eric Roeland, MD

Number of Participants With Change in Patient Reported Positional Pain Intensity

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

Number of Participants With Adverse Effects Associated With Lazanda

Overall Study

Emergencies

Cancer Pain

Pain

Breakthrough Pain

Disease Attributes

Hydromorphone

Fentanyl 100 mcg nasal spray administered plus hydromorphone PCA. All study patients receive demand dosing patient-controlled analgesia (PCA) with intravenous hydromorphone. Initial loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There will be no basal dose and the 8-hour dose limit will be 6.4 mg.

Placebo nasal spray administered plus hydromorphone PCA . All study patients receive demand dosing patient-controlled analgesia (PCA) with intravenous hydromorphone. Initial loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There will be no basal dose and the 8-hour dose limit will be 6.4 mg.

100 mcg nasal spray administered in each nostril.

Fentanyl Nasal Spray

Initial loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There will be no basal dose and the 8-hour dose limit will be 6.4 mg.

Hydromorphone PCA

1 placebo nasal spray administered in each nostril.

Placebo Nasal Spray

Knox H. Todd, MD

The goal of this clinical research study is to learn if fentanyl nasal spray can help decrease pain related to cancer when used with other drugs for pain. Researchers also want to know if this drug can help decrease the length of your stay in the Emergency Department.

In this study, fentanyl nasal spray will be compared to a placebo nasal spray. A placebo is not a drug. It looks like the study drug but it is not designed to treat any disease or illness. It is designed in this study to be compared with the study spray to learn if the study spray has any real effect.

You will also be given intravenous (IV) pain drugs. You will be given these drugs even if you decide not to take part in this study.

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to receive either fentanyl nasal spray or a placebo nasal spray. You will have an equal chance of being assigned to either group.

Neither you nor the study staff will know if you are receiving the study spray or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.

Study Visit and Study Treatment:

During your stay in the Emergency Department today, the following tests and procedures will be performed:

* Your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be recorded.
* Information from your medical record about your age, sex, race, status of the disease, and any drugs that you may be taking for pain.
* The study nurse will also ask you some questions about your pain. It should take about 5 minutes to answer these questions.

You will then begin study treatment with either the fentanyl nasal spray or placebo nasal spray. The study nurse will help you use the nasal spray.

You will stay in the Emergency Department and will be monitored for up to 8 hours after the treatment has been administered. During this time, you will be asked about your pain and any side effects you may be having. The study nurse will also monitor your IV pain drug levels and other vital signs.

Length of Treatment:

Your active participation in this study will be over after your are monitored for up to 8 hours, at which time you will either be discharged to go home or admitted to the hospital based on your pain response and any other health problems that may be found during your visit to the Emergency Department.

Follow-Up Phone Call:

About 24 hours after your participation is over, the study nurse will call you by phone to ask if you experienced any other side effects since finishing the study treatment. The phone call should only last about 5 minutes. If you are still an inpatient at the hospital, the study nurse may visit you and ask you these questions in person.

This is an investigational study. Fentanyl nasal spray is FDA approved and commercially available for the treatment of pain. It's use to help with cancer pain in the Emergency Department is investigational.

Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.

Fentanyl for Breakthrough Pain in the Emergency Department

A Randomized Controlled Double-Blind Trial of Fentanyl Nasal Spray (Lazanda) Plus Hydromorphone Demand PCA Versus Placebo Nasal Spray Plus Hydromorphone Demand PCA for Treatment of Breakthrough Cancer Pain in the Emergency Department

Primary outcome is total pain relief score (TOTPAR4) at 4 hours after treatment initiation. TOTPAR4 defined as the sum of hourly pain relief scores after baseline to four hours after the first administered dose of Lazanda or placebo. Scores range from -1 (worse pain) to 4 (complete relief). Range of possible TOTPAR4 summed scores is -4 to 16. A TOTPAR4 score greater than or equal to 8 is considered a positive response.

Archimedes Pharma US, Inc.

M.D. Anderson Cancer Center

Placebo nasal spray administered in each nostril plus hydromorphone PCA. Initial PCA loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There was no basal dose and the 8-hour dose limit was 6.4 mg.

Placebo

Fentanyl 100 mcg nasal spray administered in each nostril plus hydromorphone PCA. Initial PCA loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There was no basal dose and the 8-hour dose limit was 6.4 mg.

Intervention

Patient consented but admitted to hospital before medication administered.

No Medication

Total

Ethnicity (NIH/OMB)

Pain Score between 7 and 10 using an 11-point National Rating Scale (NRS).The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

Number of Participants with Pain Score between 7 and 10 using an 11- point (NRS)

Kumar Alagappan,Chair, Emergency Medicine

One participant consented but admitted to hospital before medication administered

Number of Participants With Total Pain Relief Score (TOTPAR4) at Four Hours After Treatment Initiation.

Placebo nasal spray administered in each nostril plus hydromorphone (PCA) Initial Patient Controlled Analgesia. (PCA) loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There was no basal dose and the 8-hour dose limit was 6.4 mg.

Nervous System Diseases

Behaviors and Mental Disorders

Neurologic Manifestations

Quality of Life

PecFent® (fentanyl) nasal spray

Yolanda Riesgo, MD

Hernan Cortes, MD

National multicenter, prospective, observational study in cancer patients with chronic background pain and breakthrough pain to whom PecFent® has been prescribed under pragmatic condition by a specialist in the treatment of cancer pain conditions.

• Study objectives include assessment of early treatment satisfaction.

Patient Satisfaction and Quality of Life Impact - PecFent®

A Spanish , Multicentre, Open-label, Observational Study to Assess Quality of Life and Satisfaction in Subjects Taking PecFent® for the Treatment of Breakthrough Cancer Pain (BTPc)

Satisfaction will be assessed using a 4-point Likert scale.

Archimedes Development Ltd

Anticoagulants

Other Dietary Supplements

Citric Acid

Sodium Citrate

Citrate

Treatment for breakthrough pain with Fentanyl Citrate Nasal Spray (FCNS)

Fentanyl Citrate Nasal Spray (FCNS)

Goetz Kloecker, MD, FACP, MBA, MSPH

Lazanda is a prescription nasal spray medicine that contains the medicine fentanyl. It is used to manage breakthrough pain in adults with cancer who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. Lazanda is started only after taking other opioid pain medicines and the patient's body has become used to them (opioid tolerant).

The purpose of this study is to assess the ability of Lazanda to control pain during an episode of breakthrough pain in cancer patients.

An Assessment of the Ability of Fentanyl Citrate Nasal Spray to Manage Breakthrough Pain in Cancer Patients.

An Assessment of the Ability of Fentanyl Citrate Nasal Spray to Manage Breakthrough Pain in Cancer Patients Without a Timely Response to Their Short-acting Opioids.

The primary efficacy outcome measure is pain intensity difference at 15 minutes (PID15) after dosing during the Maintenance Stage. (PID15 is defined as the difference between pain intensity at 15 minutes and baseline.)Maintenance stage is defined as 6 breakthrough pain episodes for up to 6 weeks.

The key secondary outcome measure is the proportion of episodes that the patient defines as satisfactorily managed at 15 minutes.

Satisfaction will be considered to have been achieved for an individual episode of BTPc(Breakthrough pain)if the patient rates pain management as "Satisfied" or "Very Satisfied." Patients complete a satisfaction questionnaire at end of study.

James Graham Brown Cancer Center

University of Louisville

Associate Professor

Sylvie Allouche, MD

Jerome Fayette, MD

Alain Serrie, MD

A French, Multicentre, Open-label, Observational Study to Assess Quality of Life and Satisfaction in Subjects Taking PecFent® for the Treatment of Breakthrough Cancer Pain (BTPc)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lazanda in Cancer Patients Receiving Palliative Radiation	NCT03071744	Bone Metastases	Lazanda	18 Years -	University of California, San Diego
Fentanyl for Breakthrough Pain in the Emergency Department	NCT01812759	Pain	Fentanyl Nasal ... Hydromorphone P... Placebo Nasal S...	18 Years - 75 Years	M.D. Anderson Cancer Center
Lazanda in Cancer Patients Receiving Palliative Radiation	NCT03071744	Bone Metastases	Lazanda	18 Years -	University of California, San Diego
Patient Satisfaction and Quality of Life Impact - PecFent®	NCT01698645	Breakthrough Ca...	PecFent® (fenta...	18 Years -	Archimedes Development Ltd
An Assessment of the Ability of Fentanyl Citrate Nasal Spray to Manage Breakthrough Pain in Cancer Patients.	NCT01839552	Pain	Fentanyl Citrat...	18 Years -	University of Louisville
Patient Satisfaction and Quality of Life Impact - PecFent®	NCT01693328	Breakthrough Ca...	PecFent® (fenta...	18 Years -	Archimedes Development Ltd

Spots Global Cancer Trial Database for lazanda

Every month we try and update this database with for lazanda cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lazanda

Every month we try and update this database with for lazanda cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lazanda cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.