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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05608876
Registration number
NCT05608876
Ethics application status
Date submitted
16/10/2022
Date registered
8/11/2022
Date last updated
17/01/2024
Titles & IDs
Public title
A Clinical Study to Investigate the Efficacy of Tigilanol Tiglate Directly in Head and Neck Cancer
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Scientific title
A Phase II, Open Label, Single Arm Study To Assess The Efficacy Of Intratumoral Tigilanol Tiglate In Various Head And Neck Solid Malignancies
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Secondary ID [1]
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U1111-1282-3152
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Secondary ID [2]
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QB46C-H08
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer
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Condition category
Condition code
Cancer
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Head and neck
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tigilanol Tiglate
Experimental: Single Arm, Open Label - Single or multiple Intratumoural injections of tigilanol tiglate at up to a fixed dose of 3.6 mg/m2 (Body Surface Area [BSA]) per treatment.
Treatment: Drugs: Tigilanol Tiglate
Tigilanol tiglate is a novel, short-chain diterpene ester in clinical development for intratumoural treatment of a wide range of solid tumours.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Tumour Response
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Assessment method [1]
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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.
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Timepoint [1]
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72 weeks
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Secondary outcome [1]
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Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [1]
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Total number of Adverse Events (AEs) and Serious Adverse Events (SAEs) and number of AEs and SAEs deemed related to tigilanol tiglate.
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Timepoint [1]
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72 weeks
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Secondary outcome [2]
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Disease Control
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Assessment method [2]
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Time from last treatment to recurrence of disease at injection site(s).
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Timepoint [2]
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72 weeks
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Secondary outcome [3]
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Local Recurrence Rate at injection site(s)
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Assessment method [3]
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Percentage of participants with local recurrence at injection site(s) at 6-,12- and 18-months after first treatment.
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Timepoint [3]
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6-, 12-, and 18-months after first treatment.
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Secondary outcome [4]
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Progression Free Survival (PFS)
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Assessment method [4]
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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.
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Timepoint [4]
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72 weeks
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Eligibility
Key inclusion criteria
1. Are willing and able to provide written informed consent for the study prior to any
protocol-specific procedures and to comply with all local and study requirements.
2. Are = 18 years of age on the day of providing informed consent.
3. Have a histologically confirmed diagnosis of a solid head and neck malignancy and have
either recurrent disease and/or metastatic disease, or have failed on at least one
line of systemic therapy. Tumour types can include: HNSCC, sino-nasal cancers,
salivary gland cancers, and peri-stomal laryngeal carcinomas with pre-existing
tracheostomy.
4. Have disease that is amenable to intratumoural injection either by palpation or under
ultrasound guided injection. Lymph nodes with metastatic disease from the patient's
head and neck cancer can be selected for treatment. Note: Measurable disease as per
RECIST v1.1. is not mandatory.
5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of = 2.
6. Have life expectancy of more than 12 weeks.
7. Female participants who are Women of Child-Bearing Potential (WOCBP) must have a
negative serum pregnancy test at Screening (within 14 days of the first study drug
administration), must be willing to use a highly effective contraception from date of
consent, throughout the study period and up to 30 days after the last study drug
administration, and must not be breastfeeding.
8. Male participants with a potentially fertile female partner are eligible if they have
had a vasectomy or are willing to use adequate contraception from prior to
commencement of study drug administration, throughout the study period and up to 30
days after the last study drug administration, and must not donate sperm throughout
the study period and up to 30 days after the last study drug administration.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Are planning to receive intratumoural treatment or radiotherapy to any of the tumours
intended for injection within 28 days prior to Screening, or during treatment with
tigilanol tiglate.
2. Have a tumour intended for injection that is immediately adjacent to, or with
infiltration into, any major artery or vein (e.g., if the tumour for injection is
located adjacent to the jugular vein).
3. Have a tumour intended for injection located in an area where post-injection swelling
could compromise the airway.
4. Have a tumour intended for injection that is a nasal tumour extending into the Ethmoid
sinus.
5. Have had any previous intervention (extensive surgery or radiation therapy) in the
area of a tumour intended for injection that is in proximity of the airway (such that
tracking of the injected fluid may be unpredictable and could lead to airway
swelling). Patients with a permanent tracheostomy can be included.
6. Are receiving or have received other investigational agents or have used an
investigational device without undergoing a 28-day (or 5 half-lives, whichever is
shorter) wash-out period prior to their first treatment with tigilanol tiglate. These
patients must have recovered from all AEs due to previous investigational therapies to
= Grade 1 at baseline.
7. Are receiving or have received systemic anticancer therapy, or therapeutic radiation
treatment, without undergoing a 28-day (or 5 half-lives, whichever is shorter)
wash-out period prior to their first treatment with tigilanol tiglate. These patients
must have recovered from all AEs due to previous therapies to = Grade 1 at baseline.
8. Have had major surgery within 28 days of their first treatment with tigilanol tiglate
or anticipate the need for major surgery during the study period. Minor surgical
procedures are permitted, but with sufficient time for wound healing.
9. Have known, current or history of active cerebral metastasis and/or carcinomatous
meningitis.
10. Have any bleeding diathesis or coagulopathy that would make intratumoural injection or
biopsy unsafe, or if they are on therapeutic warfarin therapy.
11. Have a history of allergic reactions or severe hypersensitivity (Grade = 3) attributed
to tigilanol tiglate or compounds of similar chemical or biologic composition to
tigilanol tiglate, any of its excipients or other agents used in the study.
12. In the opinion of the treating Investigator, the patient is not an appropriate
candidate for the study for any reason (e.g., they have a known psychiatric or
substance abuse disorder that would interfere with their ability to cooperate with the
requirements of the study).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/11/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2026
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Actual
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Sample size
Target
37
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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The Kinghorn Cancer Centre - Sydney
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Recruitment hospital [2]
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Metro South Hospital and Health Service, via the Princess Alexandra Hospital - Brisbane
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment postcode(s) [2]
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4102 - Brisbane
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Recruitment outside Australia
Country [1]
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United Kingdom
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State/province [1]
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Hertfordshire
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Country [2]
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United Kingdom
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State/province [2]
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Wirral
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Country [3]
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United Kingdom
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State/province [3]
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Cardiff
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Country [4]
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United Kingdom
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State/province [4]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
QBiotics Group Limited
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A Phase II, open label, single arm study to assess the efficacy of intratumoural tigilanol
tiglate in various head and neck solid malignancies.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05608876
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Richard Gallagher, MBBS
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Address
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The Kinghorn Cancer Centre
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Head of Human Clinical Operations
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Address
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Country
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Phone
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+61 (0) 738 708 933
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05608876
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