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A Clinical Study to Investigate the Efficacy of Tigilanol Tiglate Directly in Head and Neck Cancer
A Phase II, open label, single arm study to assess the efficacy of intratumoural tigilanol tiglate in various head and neck solid malignancies.
Study details:
Primary Objective. 1. To evaluate tumour ablation following treatment(s) with intratumoural injections of tigilanol tiglate.
Secondary Objectives. 1. To assess the safety and tolerability of intratumoural injections with tigilanol tiglate.
2. To evaluate disease control by assessing time to local disease recurrence from last treatment. 3.
To evaluate the tumour recurrence rate at injected tumour sites. 4. To evaluate survival by assessing Progression Free Survival (PFS).
Exploratory Objectives. 1. To assess the impact on Quality of Life (QoL).
2. To assess the degree of wound healing after each treatment. 3.
To assess the tumour response in injected and non-injected tumours, based on Response Evaluation Criteria in Solid Tumours (RECIST) v1. 1. 4.
To assess the tumour response according to intratumoural Response Evaluation Criteria in Solid Tumours (itRECIST). 5. To assess changes in tumour biomarkers.
6. To assess the tumour microenvironment.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-11-03
Primary completion: 2025-08-01
Study completion finish: 2026-10-01
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT05608876
Intervention or treatment
DRUG: Tigilanol Tiglate
Conditions
- • Head and Neck Cancer
Find a site
Closest Location:
The Kinghorn Cancer Centre
Research sites nearby
Select from list below to view details:
The Kinghorn Cancer Centre
Sydney, New South Wales, Australia
Metro South Hospital and Health Service, via the Princess Alexandra Hospital
Brisbane, Queensland, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Single Arm, Open Label
| DRUG: Tigilanol Tiglate
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Tumour Response | Proportion of participants who have achieved partial or complete ablation of treated tumour(s) and/or tumour segment(s) following injection(s) with tigilanol tiglate. | 72 weeks |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Total number of Adverse Events (AEs) and Serious Adverse Events (SAEs) and number of AEs and SAEs deemed related to tigilanol tiglate. | 72 weeks |
Disease Control | Time from last treatment to recurrence of disease at injection site(s). | 72 weeks |
Local Recurrence Rate at injection site(s) | Percentage of participants with local recurrence at injection site(s) at 6-,12- and 18-months after first treatment. | 6-, 12-, and 18-months after first treatment. |
Progression Free Survival (PFS) | Progression Free Survival (PFS) based on RECIST v1.1 defined as the length of time between first treatment and the date of the first occurrence of disease progression. | 72 weeks |
Frequently Asked Questions
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