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

NCT04042545 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: PPP001-Ph2-02
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Uncontrolled cancer pain will be measured using a patient self-administered questionnaire.

  European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 15 Palliative (EORTC-QLQ-C15-PAL). items are rated on a scale of 1 (not at all) to 4 (very much). high scores on a symptom scale correlate to increased symptom burden

  change from baseline in the EORTC-QLQ-C15-PAL pain multi-item scale score at Week 4.

Secondary Outcomes (5)

• 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.

  change from baseline in the EORTC-QLQ-C15-PAL overall QoL single-item scale score at Week 4

• The physical, emotional, and total symptom distress will be measured using a patient self administered questionnaire.

  Change from Baseline in ESAS-r-CS at Weeks 1 and 4

• The palliative performance scale will be scored by a healthcare profesional.

  Change from Baseline in PPS at Weeks 1 and 4

• The satisfaction of family caregivers of patients with advanced cancer will be measured using a caregiver self administered questionnaire.

  Change from Baseline in treatment-satisfaction questionnaire at Weeks 1 and 4

• The distress of patients with advanced cancer will be measured using a patient self-administered questionnaire

  Change from Baseline in distress thermometer at Week 4

Study Arms (2)

inhaled THC/CBD (PPP001)

EXPERIMENTAL

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

Drug: PPP001

Placebo

PLACEBO COMPARATOR

Placebo inhalation with a device

Drug: Placebo

Interventions

PPP001 DRUG

1 cannabis dosing capsule inhaled 3 times a day with a vaporizer device

Also known as: QIXLEEF

inhaled THC/CBD (PPP001)

Placebo DRUG

1 placebo dosing capsule inhaled 3 times a day with a vaporizer device

Placebo

Eligibility Criteria

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

You may qualify if:

• Written informed consent,
• Adult male and female patients at least 18 years of age,
• Subject agreed to follow the protocol,
• Advanced cancer for which there is no known curative therapy as per investigator's judgement,
• Patients experiencing at least 2 symptoms related to cancer \> 4 on ESAS-r-CS NRS including pain symptom,
• Life expectancy six weeks or longer with PPS \> 50% and PaP Score Group A (30-day survival probability \>70%),
• No cognitive impairment according to Mini-Cog©,
• The patient is able to perform deep inhalations with FEV1 more than 60%,
• Ability to read and respond to questions in English,
• 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,
• 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.

Sponsors & Collaborators

• Tetra Bio-Pharma: lead

Study Sites (1)

Scottsdale Research Institute

Cave Creek, Arizona, 85331, United States

RECRUITING

MeSH Terms

Conditions

Cancer Pain; Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tetra Bio Pharma

CONTACT

+1(438)8997575

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 2, 2019
• Study Start: July 30, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2022
• Last Updated: September 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)