NanaBis™ an Oro-buccal Administered delta9-Tetrahydrocannabinol (d9-THC) & Cannabidiol (CBD) Medicine for the Management of Bone Pain From Metastatic Cancers

NanaBis™ an Oro-buccal Administered Equimolar d9-THC & CBD Formulation as Monotherapy for Management of Opioid Requiring Bone Pain Due to Metastatic Cancer: Phase 3 Multi Centre Blinded Randomized Withdrawal Active & Placebo Controlled Trial

This is a multi-centre, long term, double blind, clinical protocol for NanaBis™ as a monotherapy treatment in participants 18-75 years of age with cancer related pain.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer Related Pain
• Intervention / Treatment: Drug: Placebo Spray; Drug: Placebo Tablet; Drug: Oxycodone IR; Drug: NanaBis™; Drug: Oxycodone CR

Detailed Description

This trial uses an alternative method to demonstrate the analgesic efficacy of NanaBis™ as a monotherapy in cancer participants. Proving analgesic efficacy requires demonstrating that (i) the analgesic is significantly better than placebo and (ii) that the magnitude of the improvement is clinically important. The latter is standardly done by measuring the change in pain levels from a baseline (no analgesia) to the end of a treatment period. A 30% decrease in the Numerical Pain Rating Scale (NPRS) has been correlated with participants reporting a moderate improvement in their pain and this was adopted as the standard method of demonstrating a clinically important magnitude of improvement. In this strategy, the measure of analgesic efficacy is the proportion of participants in the treatment group whose pain is adequately treated (responders). A responder is defined as a patient who completes the treatment phase with an acceptable level of pain (NPRS ≤ 5) and without requiring excessive amounts of rescue (breakthrough analgesia) medication. Unlimited breakthrough analgesia (Oxycodone) is allowed throughout the study; however, excessive use will result in discontinuation. Comparison of the proportion of responders in the NanaBis™ arm and placebo arms will determine if NanaBis™ is significantly better than placebo. Demonstrating that the proportion of responders in the NanaBis™ arm is non-inferior to the Oxycodone controlled release (CR) comparator arm will determine if the magnitude of improvement (provided by NanaBis™) is clinically important because Oxycodone CR has been established as the benchmark analgesic that provides a clinically important effect.

• Study Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Prof. Luis Vitetta; Phone Number: 106 +61 8188 0311; Email: luis_vitetta@medlab.co
• Study Contact Backup: Name: Dr. Michael Lyon; Phone Number: +1 604 777 5500; Email: doctorlyon@me.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

At Screening Phase

Participants must fulfil all of the following criteria:

• Prospective male and female participants that are:

  1. in the age range 18-65 years or
  2. 65 to 75 years without significant co-morbidities (heart, lung, liver or renal failure, myocardial infarction, cerebral vascular accident, peripheral vascular disease, chronic obstructive pulmonary disease, dementia, connective tissue disease or diabetes mellitus with end-organ damage)
• Metastatic bone pain from a cancer diagnosis is the only major cause of pain.
• Documented proof (imaging) confirming the Metastatic Bone Disease at the current site of pain and that there has no been treatment since diagnosis
• Meet International Classification of Diseases, Tenth Revision (ICD-10) codes for pain management criteria (i.e., bone cancer pain)
• During the screening period, the participant is on stable opioid pain management and pain severity (NPRS) ≤ 8 with a maximum variation of ± 1
• Pain Detect score > 18

• Participant willing and able to provide informed consent and follow study procedures

  1. including agreeing to not drive or operate heavy machinery; and
  2. females of child-bearing potential agree to use reliable contraception during the duration of the clinical trial
• Patient deemed tolerable to Oxycodone and NanaBis™ determined by medical history of allergies to cannabinoids or opioids
• Patient must not be a participant in a clinical trial or study.

Exclusion Criteria:

At Screening Phase

Participants will be excluded if they meet any of the following criteria that include:

• History of epilepsy or recurrent seizures

• Moderate to severe medical conditions such as

  1. Severe hepatic, cardiovascular, pulmonary or renal impairment or
  2. Psychiatric disorders (i.e., unstable schizophrenia, recent drug-induced psychosis, severe mood disorders), that would be assessed at the medical screen
• If participants have been diagnosed with a current substance abuse disorder
• Women who are pregnant, lactating or planning to become pregnant
• Identified concerns by the nursing / medical team relevant to the safe storage of medications (i.e., NanaBis™ or standard medical therapy)
• Participants who may not be available for follow up (i.e., planned or expected travel or other)
• Participants plan to undergo any treatment that will substantially reduce the burden of disease (and therefore bone pain) during the screening, titration or maintenance phase of the clinical trial such as radiotherapy or cytotoxic chemotherapy
• Participants who are unable to withhold all analgesia (apart from which is part of this trial) during the titration and maintenance phase of the study, including bisphosphonates, or are currently exceeding equivalence of 70mg BD Oxycodone CR. Medications such as bisphosphonates may be coordinated so they are given either side of the excluded period that covers the titration and maintenance phases
• Participants will NOT be excluded if they are being treated with maintenance pharmacotherapy to prevent progression of disease such as steroids and hormone therapy, which may be continued during the trial at a stable dose
• Participant will be excluded if they are participating in any other clinical trial or study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Double Placebo Arm; Spray Placebo + Tablet Placebo Spray Placebo is a nanoparticle water soluble solution without cannabinoids containing a small amount of hemp seed oil (for fragrance purposes only) as defined by Australian Office of Drug Control (ODC) (https://www.odc.gov.au/hemp-products). One dose is equivalent to 2 actuations of the pump delivering 280 µL volume. Tablet Placebo will be identical to the Oxycontin tablets.	Drug: Placebo Spray; Placebo comparator used against both NanaBis™ and Oxycodone depending on randomisation of arms.; Other Names: NanoCelle® Placebo Spray; Drug: Placebo Tablet; Placebo comparator used against both NanaBis™ and Oxycodone depending on randomisation of arms.; Drug: Oxycodone IR; Oxycodone immediate release (IR) tablet or capsule or oral solution used as breakthrough analgesia.; Other Names: Oxyfast®; Oxy IR®; Oxaydo®; Roxicodone®
Experimental: Treatment NanaBis™ Arm; NanaBis™ + Tablet Placebo NanaBis™ is a nanoparticle water soluble equimolar solution of d9-THC and CBD. One dose is equivalent to 2 actuations of the pump delivering 280 µL volume containing 2.5 mg d9-THC and 2.5 mg CBD. The dose administered will be 1 - 3.5 doses (2 sprays to 7 sprays) per 4 hours unless asleep.	Drug: Placebo Tablet; Placebo comparator used against both NanaBis™ and Oxycodone depending on randomisation of arms.; Drug: Oxycodone IR; Oxycodone immediate release (IR) tablet or capsule or oral solution used as breakthrough analgesia.; Other Names: Oxyfast®; Oxy IR®; Oxaydo®; Roxicodone®; Drug: NanaBis™; NanaBis™ is a nanoparticle water soluble equimolar solution of d9-THC & CBD. One dose is equivalent to 2 actuations of the pump delivering 280 µL volume containing 2.5 mg d9-THC and 2.5 mg CBD; Other Names: MDCNB-01; NanoCelle® d9-THC & CBD
Active Comparator: Comparator (Oxycodone) Arm; Spray Placebo + Oxycodone CR Spray Placebo is a nanoparticle water soluble solution without cannabinoids containing a small amount of hemp seed oil (for fragrance purposes only) as defined by Australian ODC (https://www.odc.gov.au/hemp-products). One dose is equivalent to 2 actuations of the pump delivering 280 µL volume. Oxycodone controlled release (CR) used as a comparator will be Oxycontin tablets 10 mg - 70 mg po bd.	Drug: Placebo Spray; Placebo comparator used against both NanaBis™ and Oxycodone depending on randomisation of arms.; Other Names: NanoCelle® Placebo Spray; Drug: Oxycodone IR; Oxycodone immediate release (IR) tablet or capsule or oral solution used as breakthrough analgesia.; Other Names: Oxyfast®; Oxy IR®; Oxaydo®; Roxicodone®; Drug: Oxycodone CR; Oxycodone CR tablet is an opioid agonist supplied in 10 mg, 15 mg, 20 mg, 30 mg,40 mg, 60 mg and 80 mg tablets for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt.; Other Names: Targin®; OxyNorm®; OxyContin®; Endone®; Proladone®; Xtampza ER®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Significant changes in responders with NanaBis™ spray over placebo (p<0.05)	To demonstrate that at the end of the 6-week study period the proportion of responders in the NanaBis™ group shows significant change than the proportion of responders in the placebo group. A responder is defined as a participant who completes the maintenance phase with an acceptable level of pain (NPRS is equal to 5) and without requiring excessive amounts of rescue (breakthrough analgesia) medication. NPRS Assessment [Time Frame: Baseline and then twice daily for the duration of the study]. The NPRS questionnaire is completed by the participant to determine their pain intensity. The NPRS is an 11-point scale scored from '0-10'. A score of '0' being no pain and a score of '10' being the most intense pain imaginable. Participants select the value that is most in line with the intensity of pain they have experienced in the last 24 hours.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparable efficacy in proportion of responders from NanaBis™ spray to the proportion of responders to Oxycodone CR	To demonstrate that at the end of the 6-week study period the proportion of responders in the NanaBis™ group is similar to the proportion of responders in the Oxycodone group determined by pain levels recorded using NPRS. A responder is defined as a participant who completes the maintenance phase with an acceptable level of pain (NPRS is equal to 5) and without requiring excessive amounts of rescue (breakthrough analgesia) medication. NPRS Assessment [Time Frame: Baseline and then twice daily for the duration of the study]. The NPRS questionnaire is completed by the participant to determine their pain intensity. The NPRS is an 11-point scale scored from '0-10'. A score of '0' being no pain and a score of '10' being the most intense pain imaginable. Participants select the value that is most in line with the intensity of pain they have experienced in the last 24 hours.	6 weeks
Significant change in the Health-Related Quality of Life Scores with NanaBis™ spray over placebo (p<0.05) and comparable to Oxycodone CR	To demonstrate that at the end of the 6-week study period the Health-Related Quality of Life scores in the NanaBis™ treated group are significantly changed than in the Placebo group and is similar to the Oxycodone CR treated group. Quality of life as assessed by the EORTC-QLQ-C30 validated questionnaire [ Time Frame: Baseline and then weekly during the maintenance phase of the study and at then weeks 7 and 18 of the Open Label Extension]. The EORTC-QLQ-C30 is validated questionnaire answered by participants to assess the quality of life of cancer patients. It assesses important functioning domains (e.g. physical, emotional, role) and common cancer symptoms (e.g. fatigue, pain, nausea/vomiting, appetite loss).	6 weeks
Significant change in the NPRS score with NanaBis™ spray over placebo (p<0.05) and comparable to Oxycodone CR	NPRS Assessment [Time Frame: Baseline and then twice daily for the duration of the study]. The NPRS questionnaire is completed by the participant to determine their pain intensity. The NPRS is an 11-point scale scored from '0-10'. A score of '0' being no pain and a score of '10' being the most intense pain imaginable. Participants select the value that is most in line with the intensity of pain they have experienced in the last 24 hours.	18 weeks
NanaBis™ Adverse Events	To demonstrate that at the end of the 6-week study period that NanaBis™ is safe and tolerable. Safety and tolerability will be assessed via standardised adverse events, Serious adverse events, Deaths, UKU - Side Effects Rating Scale (UKU), Local Adverse Events Charts and patient medical records. Adverse events, serious adverse events and deaths will be summarised by treatment arm. Does the daily use of NanaBis™ oro-buccal spray reduce the severity of Treatment-Emergent Adverse Events (safety and tolerability). [Time Frame: Baseline and then weekly for the duration of the study]. Changes in validated UKU scale range is 0 to 3 for rating the degree of severity (mild, moderate or severe) and a second scale for the investigator that assigns a casual relationship of improbable, possible or probable.	18 weeks
Fifty percent or greater of the NanaBis™ treated group request compassionate extension with NanaBis™ spray	To demonstrate that at the end of the 6-week study period that after unblinding, half or more of the NanaBis™ treated group prefer further treatment with NanaBis™ in the open label extension phase (note that all participants will be all offered open label extension if appropriate).	12 weeks

Collaborators and Investigators

• Sponsor: Medlab Clinical
• Collaborators: George Clinical Pty Ltd; WriteSource Medical Pty Ltd

Publications and helpful links

General Publications

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Helpful Links

• Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - annotated with TGA comments. DSEB. 2000.
• Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (CPMP/ICH/377/95). Annotated with TGA comments,. 2001.
• VA Evidence-based Synthesis Program Reports. In Benefits and Harms of Cannabis in Chronic Pain or Post-traumatic Stress Disorder: A Systematic Review, Department of Veterans Affairs (US): Washington (DC), 2017.
• Pilot clinical and pharmacokinetic study of a water soluble nanoparticle cannabis-based medicine in advanced cancer with intractable pain. S. Clarke, B. Butcher, A.J McLachlan, J.D Henson, D. Rutolo, S. Hall, L. Vitetta. 2020. Abstract 219

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2023
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Treatment; Cancer Pain; Monotherapy; Cannabidiol; Nanoparticle; Tetrahydrocannabinol; Cannabis based medicine; d9-tetrahydrocannabinol; Cancer Bone Pain
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Pain; Neurologic Manifestations; Neoplastic Processes; Neoplasm Metastasis; Cancer Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Oxycodone
• Other Study ID Numbers: MDC-NB-P3-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No