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Safety and Efficacy of Inhaled Cannabis (Synthetic THC/CBD) for Improving Quality of Life in Advanced Cancer Patients (Serenity)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04001010
Recruitment Status : Not yet recruiting
First Posted : June 27, 2019
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
MedQualis
Information provided by (Responsible Party):
Tetra Bio-Pharma

Brief Summary:
This phase 3 clinical trial assess the safety and efficacy of a second-generation cannabinoid-based drug to improve quality of life in 334 advanced cancer patients with uncontrolled symptoms. This is a 4-week treatment period study followed by an open label period of 2 years. This international multi-centric study which takes place in approximately 20 sites in Canada and US.

Condition or disease Intervention/treatment Phase
Cancer Pain Quality of Life Pain, Acute Cannabis Use Drug: PPP011 Drug: Placebo Phase 3

Detailed Description:
This is a 4-week randomized, double-blind, placebo-controlled, parallel group design trial to evaluate the safety and efficacy of inhaled PPP011 on HRQoL in patients with uncontrolled symptoms related to advanced incurable cancer.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of PPP011-kit for Improving Health Related Quality of Life in Patients With Advanced Cancer and Uncontrolled Symptoms: A Randomized, Double-blind, Placebo-Controlled, Parallel Group Study
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2022

Arm Intervention/treatment
Experimental: inhaled THC/CBD (PPP011)
PPP011 (synthetic THC/CBD) inhalation with mighty medic device
Drug: PPP011
1 capsule inhaled 3 times a day with a vaporizer device
Other Name: CAUMZ

Placebo Comparator: Placebo
Placebo inhalation with mighty medic device
Drug: Placebo
1 capsule inhaled 3 times a day with a vaporizer device




Primary Outcome Measures :
  1. The overall HRQoL (Health related Quality of Life) of patients with uncontrolled symptoms related to advanced cancer will be measured using a patient self rating questionnaire. [ Time Frame: change from baseline in the EORTC-QLQ-C15-PAL overall QoL single-item scale score at Week 4 ]
    The QoL will be measured using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 15 Palliative (EORTC-QLQ-C15-PAL) item 15. Scale range is 1 to 7; 1 (very poor) being the worst rating to the maximal rating of 7 (Excellent).

  2. Uncontrolled cancer pain will be measured using a patient self rating questionnaire. [ Time Frame: change from baseline in the EORTC-QLQ-C15-PAL pain multi-item scale score at Week 4. ]
    The uncontrolled cancer pain will be measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 15 Palliative (EORTC-QLQ-C15-PAL) item 5 and 12. Scale range is 1 to 4; 1 (not at all) being the worst rating to the maximal rating of 4 (Very Much).


Secondary Outcome Measures :
  1. The total dose of concomitant medication to control cancer symptoms and pain will be recorded. [ Time Frame: Change from Baseline in concomitant medication at Weeks 1 and 4 ]
    The dosage of all medications taken by the patient in 24 hours will be recorded after starting treatment with PPP011. Opioids consumption will be measured using the oral morphine equivalent daily dose (MEDD).

  2. The cannabinoids concentration level will be measured [ Time Frame: Observed cannabinoids concentration level at baseline, week 1 and week 4, before and 1-hour after inhalation ]
    The cannabinoids concentration level will be measured by a blood sampling before inhalation and and 1 hour +/- 15 min after inhalation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent,
  2. Adult male and female patients at least 18 years of age,
  3. Subject agreed to follow the protocol.
  4. Advanced cancer for which there is no known curative therapy.
  5. Patients experiencing at least 2 symptoms related to cancer > 4 on ESAS-r-CS NRS including pain symptom.
  6. Life expectancy six weeks or longer with PPS > 50% and PaP Score Group A (30-day survival probability >70%).
  7. Negative confusion assessment according to CAM.
  8. The patient is able to perform deep inhalations with FEV1 more than 60%.
  9. Ability to read and respond to questions in French or English.
  10. A female volunteer must meet one of the following criteria:

    If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first drug administration, during the study and for at least 60 days after the last dose.

    If of non-childbearing potential - should be surgically sterile or in a menopausal state.

  11. A male volunteer with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must be surgically sterile or agrees to use one of the accepted contraceptive regimens from first drug administration until 3 months after the last drug administration.

Exclusion Criteria:

  1. Previous serious adverse event or hypersensitivity to cannabis or cannabinoids.
  2. Inability to understand and comply with the instructions of the study and the inhalation procedure.
  3. Presence of significant cardiac disease (history of unstable ischemic heart disease, heart failure, severe and uncontrolled hypertension) that, in the opinion of the investigator, would put the patient at risk of a clinically significant arrhythmia or myocardial infarction.
  4. History of addiction or potential abuse substances (such as: alcohol, cocaine, amphetamines and methamphetamines).
  5. Life-time history of schizophrenia, bipolar disorder, or previous psychosis with or intolerance to cannabinoids.
  6. Current or history of suicidal ideation.
  7. Pregnant, breast-feeding or female patients of child-bearing potential and male patients whose partner is of child-bearing potential, unless willing to ensure that they or their partner use effective contraception.
  8. Cancer patients may have increased liver enzymes or renal function impairment as a consequence of their disease. However, if at the screening time, there is evidence of grade equal or superior to 3 liver or kidney toxicity associated with their previous oncology treatment, they won't be allowed to be screened in the study. Patients won't be randomized if AST/ALT > 5 x ULN or Bilirubin > 3 x ULN or Creatinine > 3 x ULN before the baseline visit.
  9. Positive confusion assessment according to CAM.
  10. Patient has any planned clinical interventions or curative cancer treatments.
  11. Epilepsy
  12. The patient is currently using or has used cannabinoid-based medications within 30 days prior to the screening visit and is unwilling to abstain for the duration of the study. If the patient is an occasional cannabis user (Cannabis use in any form: 1-3 times/week) he or she must agree to a 7-day washout period where they will refrain from any cannabis use. After 1-week of cannabis abstinence, THC blood levels will be verified, and results must be negative, or the patient won't be randomized in the study.
  13. Curative cancer treatment wash-out period of less than 2 weeks before baseline.
  14. Participation in another clinical trial within 30 days prior to the enrolment in this trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04001010


Contacts
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Contact: Harneet Arora, PhD +1 514 526-0626 ext 240 HArora@medqualis.com
Contact: Sophie Matharan, PhD +1 438 899 7575 ext 225 smatharan@tetrabiopharma.com

Locations
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Canada, Ontario
Royal Victoria Regional Health Centre Not yet recruiting
Barrie, Ontario, Canada
Contact: Russell, MD         
Grand River Hospital Not yet recruiting
Kitchener, Ontario, Canada
Contact: Jakda, MD         
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS) Not yet recruiting
Sherbrooke, Quebec, Canada
Contact: Michel Pavic, MD         
Sponsors and Collaborators
Tetra Bio-Pharma
MedQualis
Investigators
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Principal Investigator: Martin Chasen, MD William Osler Health Service Brampton

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Responsible Party: Tetra Bio-Pharma
ClinicalTrials.gov Identifier: NCT04001010     History of Changes
Other Study ID Numbers: PPP011-Ph3-01
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tetra Bio-Pharma:
cannabinoids
palliative care
QoL
Additional relevant MeSH terms:
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Cancer Pain
Acute Pain
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pain
Neurologic Manifestations
Signs and Symptoms