Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04907851


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT04907851
Ethics application status
Date submitted
25/05/2021
Date registered
1/06/2021
Date last updated
8/03/2024

Titles & IDs
Public title
A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2)
Scientific title
A Modular, Phase II, Open-Label, Multicentre Study to Assess the Preliminary Efficacy and Safety of RXC004, in Patients With Advanced Solid Tumours That Have Progressed Following Therapy With Current Standard of Care
Secondary ID [1] 0 0
MK-3475-E86
Secondary ID [2] 0 0
RXC004/0003
Universal Trial Number (UTN)
Trial acronym
KEYNOTE-E86
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
Core

* At least one lesion that is measurable by RECIST 1.1 at baseline (within 6 weeks prior to start of study treatment).
* Mandatory paired biopsies; Patients must have at least one lesion suitable for biopsy at screening
* Adequate organ and marrow function
* Female patients of childbearing potential must have a negative pregnancy test prior to start of dosing
* Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to use a highly effective method of contraception during the study from the time of treatment initiation, and for at least 5 months after the last dose of study drug.

Module 1 (PDAC) Specific Inclusion Criteria

* Histological documentation of advanced (unresectable)/metastatic (Stage III/IV) PDAC, with documented loss of function tumour mutation in RNF43
* Patients must have received one prior systemic treatment for advanced (unresectable)/metastatic PDAC (Stage III/IV), with clear evidence of radiological disease progression
* Patients must be enrolled and receive first dose of study treatment within 6 weeks of radiologically confirmed progression
* Karnofsky performance status =70.

Module 2 and Module 3 (BTC) Specific Inclusion Criteria

* Histological documentation of advanced (unresectable)/metastatic (Stage III/IV) BTC (intrahepatic or extrahepatic cholangiocarcinoma, ampulla of Vater, or gallbladder cancer)
* Patients must have received one prior systemic treatment for advanced (unresectable)/metastatic BTC, with clear evidence of radiological disease progression
* Patients must be enrolled and receive first dose of study treatment within 6 weeks of radiologically confirmed progression
* ECOG status 0 or 1.

Core
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior therapy with a compound of the same mechanism of action as RXC004
* Patients at higher risk of bone fractures
* Any known uncontrolled inter-current illness or persistent clinically significant toxicity related to prior anti-cancer treatment
* Patients who have any history of an active (requiring treatment) other malignancy within 2 years of study entry
* Patients with known or suspected brain metastases
* Use of anti-neoplastic agents
* Patients with a known hypersensitivity to any RXC004 excipients
* Patients with a contra-indication for denosumab treatment
* Patients who are pregnant or breast-feeding
* Known active human immunodeficiency viruses (HIV), hepatitis B (HBV), or hepatitis C (HCV) infections
* Use of any live or live-attenuated vaccines against infectious diseases (e.g., influenza nasal spray, varicella) within 4 weeks (28 days) of initiation of study treatment
* Mean resting corrected QTcF >470 ms, obtained from triplicate ECGs performed at screening.

There are no exclusion criteria specific to Modules 1 and 2.

Module 3 Specific

* Patients with any contraindication to the use of pembrolizumab as per approved label
* Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor, and was discontinued from that treatment due to a Grade 3 or higher AE
* Has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of pembrolizumab in this study
* Has severe hypersensitivity (= Grade 3) to pembrolizumab and/or any of its excipients
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease
* Has an active infection requiring systemic therapy
* Patients with a history of allogeneic tissue/solid organ transplant
* Patients with active infections, including tuberculosis, HIV, HBV, or HCV

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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/11/2023
Sample size
Target
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Redx Pharma Plc
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04907851

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 45
Wollongong Hospital
Recruitment postcode(s) [1] 50
2500
Funding & Sponsors
Funding source category [1] 63
Charities/Societies/Foundations
Name [1] 63
Australian Genomic Cancer Medicine Centre Ltd t/a Omico
Address [1] 63
Level 7, 370 Victoria Street Darlinghurst NSW 2010
Country [1] 63
Australia
Funding source category [2] 64
Commercial sector/Industry
Name [2] 64
Redx Pharma Plc
Address [2] 64
Block 33 Mereside, Alderley Park Alderley Edge, Cheshire SK10 4TG
Country [2] 64
United Kingdom
Primary sponsor
Commercial sector/Industry
Primary sponsor name
Redx Pharma Plc
Primary sponsor address
Block 33
Mereside, Alderley Park
Alderley Edge, Cheshire
SK10 4TG
Primary sponsor country
United Kingdom
Secondary sponsor category [1] 62
Charities/Societies/Foundations
Name [1] 62
Australian Genomic Cancer Medicine Centre Ltd t/a Omico
Address [1] 62
Level 7, 370 Victoria Street Darlinghurst NSW 2010
Country [1] 62
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 40
St Vincent’s Hospital HREC
Address [1] 40
Research Office St Vincent’s Hospital Translational Research Centre 97-105 Boundary Street Darlinghurst NSW 2010
Country [1] 40
Australia
Date submitted for ethics approval [1] 40
Approval date [1] 40
18/08/2021
Ethics approval number [1] 40
 
Public notes

Contacts
Principal investigator
Title 297 0
Dr
Name 297 0
Lorraine Chantrill
Address 297 0
Head of Department Medical Oncology L3 Illawarra Cancer Care Centre Wollongong Hospital New Dapto Rd Wollongong NSW 2500
Country 297 0
Australia
Phone 297 0
+61 2 4222 5260
Fax 297 0
Email 297 0
[email protected]
Contact person for public queries
Title 298 0
Dr
Name 298 0
Enmoore Lin
Address 298 0
The George Institute for Global Health Level 5, 1 King St Newtown NSW 2042
Country 298 0
Australia
Phone 298 0
+61 2 8052 4511
Fax 298 0
Email 298 0
[email protected]
Contact person for scientific queries
Title 299 0
Mr
Name 299 0
Craig Tilston
Address 299 0
Redx Pharma Plc Block 33 Mereside Alderley Park Alderley Edge, Cheshire SK10 4TG
Country 299 0
United Kingdom
Phone 299 0
+44 1625 469908
Fax 299 0
Email 299 0
[email protected]