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Trial registered on ANZCTR


Registration number
ACTRN12624000588594p
Ethics application status
Not yet submitted
Date submitted
9/04/2024
Date registered
8/05/2024
Date last updated
8/05/2024
Date data sharing statement initially provided
8/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical study assessing the preliminary efficacy and safety of RXC004, in Patients with Advanced Pancreatic Cancer that have Progressed following Therapy with Current Standard of Care
Scientific title
A Phase 2, Open-Label, Multicentre Study to Assess the Preliminary Efficacy and Safety of RXC004, in Patients with Advanced Pancreatic Cancer that have Progressed following Therapy with Current Standard of Care
Secondary ID [1] 311913 0
None
Universal Trial Number (UTN)
Trial acronym
PORCUPINE2 Australian Extension
Linked study record
ACTRN12616000908437
Participants in this trial will be referred from ACTRN12616000908437.

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer 333504 0
Condition category
Condition code
Cancer 330180 330180 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
RXC004 - Participants will be commenced on treatment with RXC004 (0.5mg or 1mg capsules) at 2.0 mg orally once a day in a fasted state. Participants will remain on treatment until clinical or RECIST 1.1-defined radiological progression, unacceptable toxicity, initiation of alternative anti-cancer therapy or patient decision to withdraw from treatment with Investigational Medicinal Product (IMP). Adherence will be assessed by collection of a patient diary cards and counting of returned capsules, during the site visits and documented in the source documents and electronic case report form (eCRF).
Denosumab - Participants will be commenced on prophylactic treatment with Denosumab with a 120mg, subcutaneous injection, once every month. The rationale for its prophylactic use in all patients is as a bone-protection measure based on the increased risk of bone fragility with RXC004 treatment.
Intervention code [1] 328382 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337934 0
Progression Free Survival (PFS) rate
Timepoint [1] 337934 0
6 months from start of study treatment
Secondary outcome [1] 433796 0
Objective Response Rate (ORR)
Timepoint [1] 433796 0
Every 6 weeks until disease progression
Secondary outcome [2] 433797 0
Disease control rate (DCR)
Timepoint [2] 433797 0
Every 6 weeks until disease progression
Secondary outcome [3] 433798 0
Percentage change in tumour size
Timepoint [3] 433798 0
Every 6 weeks until disease progression
Secondary outcome [4] 433799 0
Duration of response
Timepoint [4] 433799 0
Every 6 weeks until date of disease progression or death in the absence of disease progression.
Secondary outcome [5] 433800 0
Overall survival
Timepoint [5] 433800 0
Every 6 weeks after discontinuation of study treatment until death due to any cause

Eligibility
Key inclusion criteria
1. >=18 years of age at the time of signing the informed consent
2. Ability to give written informed consent and capable of understanding the protocol requirements
3. At least one lesion that is measurable by RECIST 1.1 at baseline (must not be chosen for the mandatory and optional biopsies)
4. Mandatory biopsy at screening (must not be a target lesion for RECIST 1.1), optional biopsy at C1D15
5. Adequate organ and marrow function
6. WOCBP and partners of participants who are WOCBP must adhere to contraception requirements
7. Histological documentation of advanced (unresectable)/metastatic (Stage III/IV) pancreatic ductal adenocarcinoma, with documented loss of function tumour mutation in RNF43 from centralised genetic pre-screening activities or from a recognised panel in agreement with sponsor
8. Patients must have received one prior systemic treatment for advanced (unresectable)/metastatic pancreatic ductal adenocarcinoma (Stage III/IV), with clear evidence of radiological disease progression
9. Patients must be enrolled and receive first dose of study treatment within 6 weeks of radiologically confirmed progression
10. Karnofsky performance status >=70 with no deterioration in the 2 weeks prior to first dose and an estimated life expectancy of greater than 12 weeks
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior therapy with a compound of the same mechanism of action as RXC004
2. Patients at higher risk of bone fractures
3. Any known uncontrolled inter-current illness or persistent clinically significant toxicity related to prior anti-cancer treatment which in the investigator's opinion makes it undesirable for the patient to participate in the study
4. Patients who have any history of an active other malignancy within 2 years of study entry
5. Patients with known or suspected brain metastases
6. Use of anti-neoplastic agents (including immunotherapy and investigational agents) within 3 weeks prior to the first dose of study treatment, or any residual AEs from prior anti-cancer therapies that have not resolved to Grade =1. Use of any investigational drugs within 3 weeks prior to the first dose of study treatment is also prohibited
7. Patients with a known hypersensitivity to any RXC004 excipients
8. Patients with a contra-indication for denosumab treatment
9. Patients who are pregnant or breast-feeding
10. Known active HIV, hepatitis B (HBV), or hepatitis C (HCV) infections
11. Use of any live or live-attenuated vaccines against infectious diseases within 4 weeks of initiation of study treatment
12. Mean resting corrected QTcF >470 ms

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2024
Actual
Date of last participant enrolment
Anticipated
15/01/2026
Actual
Date of last data collection
Anticipated
15/07/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316261 0
Government body
Name [1] 316261 0
Cancer Institute NSW
Country [1] 316261 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Genomic Cancer Medicine Centre Ltd t/a Omico
Address
Country
Australia
Secondary sponsor category [1] 318450 0
None
Name [1] 318450 0
Address [1] 318450 0
Country [1] 318450 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315085 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 315085 0
Ethics committee country [1] 315085 0
Australia
Date submitted for ethics approval [1] 315085 0
27/05/2024
Approval date [1] 315085 0
Ethics approval number [1] 315085 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133614 0
Prof Lorraine Chantrill
Address 133614 0
Illawarra Shoalhaven Local Health District, L3 Illawarra Cancer Care Centre, Wollongong Hospital, New Dapto Rd Wollongong NSW 2500
Country 133614 0
Australia
Phone 133614 0
+61 242225260
Fax 133614 0
Email 133614 0
lorraine.chantrill@health.nsw.gov.au
Contact person for public queries
Name 133615 0
Elizabeth Reich
Address 133615 0
The George Institute for Global Health, Level 18, International Towers 3, 300 Barangaroo Ave, Barangaroo NSW 2000
Country 133615 0
Australia
Phone 133615 0
+61 401051316
Fax 133615 0
Email 133615 0
EReich@georgeinstitute.org.au
Contact person for scientific queries
Name 133616 0
Lorraine Chantrill
Address 133616 0
Illawarra Shoalhaven Local Health District, L3 Illawarra Cancer Care Centre, Wollongong Hospital, New Dapto Rd Wollongong NSW 2500
Country 133616 0
Australia
Phone 133616 0
+61 242225260
Fax 133616 0
Email 133616 0
lorraine.chantrill@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There are no plans for this to occur at this time and participant consent will be required


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.