Safety and Efficacy of Inhaled Cannabis For the Uncontrolled Pain Relief in Patients With Advanced Cancer (PLENITUDE)

Tetra Bio-Pharma

Status and phase: Unknown; Phase 2

Conditions: Cancer Pain; Quality of Life; Pain, Acute; Cannabis Use

Treatments: Drug: PPP001; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04042545

PPP001-Ph2-02

Details and patient eligibility

About

This phase 2 multicenter clinical trial assess the safety and efficacy of inhaled PPP001 to relieve the pain in 78 advanced cancer patients with uncontrolled symptoms. This is a 4-week treatment period study followed by an open label period of 1 year.

Full description

This is a 4-week randomized, double-blind, placebo-controlled, parallel group design trial to evaluate the safety and efficacy of inhaled PPP001 on uncontrolled cancer pain in patients with symptoms related to advanced incurable cancer.

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 as per investigator's judgement,

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. No cognitive impairment according to Mini-Cog©,

8. The patient is able to perform deep inhalations with FEV1 more than 60%,

9. Ability to read and respond to questions in 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 2 patient groups, including a placebo group

inhaled THC/CBD (PPP001)

Experimental group

Description:

PPP001 (cannabis dosing capsule with THC/CBD) inhalation with a device

Treatment:

Drug: PPP001

Placebo

Placebo Comparator group

Description:

Placebo inhalation with a device

Treatment:

Drug: Placebo