Unique Treatment of Oncology Pain in Advanced Cancer (NCT06533657) | Clinical Trial Compass
CompletedPhase 2
Unique Treatment of Oncology Pain in Advanced Cancer
Canada11 participantsStarted 2025-06-12
Plain-language summary
This will be a proof-of-concept, single arm study with a maximum of 20 patients to evaluate preliminary analgesic efficacy and safety of Trichomylin® in patients with advanced cancer (male and female) who suffer from moderate to severe chronic pain and who are taking a stable dose of long-acting opioid therapy for at least 1 week prior to screening.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participant has voluntarily agreed to study participation by giving written informed consent and must be ≥18 years of age on the day of signing the informed consent form (ICF).
✓. Participant has advanced solid malignant tumors not amenable to curative-intent therapy (locally advanced unresectable or metastatic).
✓. Participant life expectancy is ≥3 months at screening according to investigator's best judgement.
✓. Participant has a clinical diagnosis of moderate to severe cancer-related pain with average daily pain score to be ≥4 for at least 4 out of the 7-day screening period, despite ongoing opioid treatment, as evidenced by their response to the BPI-SF Question #5 on the Numeric Rating Scale (NRS).
✓. Participant is taking a stable dose of opioid therapy (Step III according to the World Health Organization \[WHO\] analgesic ladder) for at least 1 week prior to screening to relieve cancer-related pain.
✓. Participant has adequate organ function, as indicated by the following laboratory values, at screening:
✓. Baseline serum electrolytes must be within the normal range per local laboratories (for baseline serum electrolytes that are out of range, these may be corrected, and the potential participant may be rescreened).
✓. Stable renal function (estimated glomerular filtration rate \[eGFR\] \>15).
Exclusion criteria
✕. Female participants who are pregnant or lactating.
✕
What they're measuring
1
Number of Participants That Reach the Stable Dose during Dose Titration
Timeframe: Baseline (i.e. Day 1 Dose Titration) and Stable Dose Day 1, up to 14 days
2
Change in Average Pain Scores from Baseline to Investigational Product Discontinuation
Timeframe: Baseline and Investigational Product Discontinuation, up to 23 days
3
Proportion of Responders to Average Pain from Baseline to Investigational Product Discontinuation
Timeframe: Baseline and Investigational Product Discontinuation, up to 23 days
4
Number of Participants That Reach the Stable Dose during Dose Titration and Respond to Average Pain from Baseline to Investigational Product Discontinuation
Timeframe: Baseline and Investigational Product Discontinuation, up to 23 days
5
Change in Average Pain from Baseline to End of the Titration
Timeframe: Baseline and End of Dose Titration, up to 14 days
6
Change in Pain Interference from Baseline to End of the Titration
Timeframe: Baseline and End of DoseTitration, up to 14 days
7
Change in Pain Interference from Baseline to Investigational Product Discontinuation
. Participant has uncontrolled psychiatric disorders (severe depression or anxiety, personality disorder, psychosis, or schizophrenia).
✕. Participant has a family history of schizophrenia.
✕. Participant has current or history of suicidal behavior or ideation assessed by Columbia-Suicide Severity Rating Scale (C-SSRS).
✕. Participant has any known or suspected history of a diagnosed dependency disorder, including opioid abuse, current heavy alcohol consumption (i.e. more than 10 units of alcohol per week or 4 units on any given day \[1 unit = 150 mL of wine, 260 mL of beer, or 45 mL of 40% alcohol\]), current use of an illicit drug or current non-prescribed use of any prescription drug (Alcohol, Smoking and Substance Involvement Screening Test \[ASSIST\]).
✕. Participant has engaged in medicinal or recreational use of any cannabinoid containing substance, in any form within the 30 days prior to screening.
✕. Participant is within the first cycle of a new line of anticancer therapy (including but not limited to chemotherapy or other systemic anticancer therapies, immunotherapy, radiation therapy, or surgery) at the start of the screening period.
✕. Participant has had any major surgery within 4 weeks prior to screening.
Timeframe: Baseline and Investigational Product Discontinuation, up to 23 days