Trial purpose
Cancer treatment
Tumor type
Upper gastrointestinal tract
Age
18+
Trial acronym
Porcupine P2EA
Clinical summary
Summary
You may be eligible for this study if you are participating in the Cancer Molecular Screening and Therapeutics (MoST) Program (Study ID: ACTRN12616000908437) and have RNF43-positive pancreatic ductal adenocarcinoma that has progressed following therapy with current standard of care.
All eligible participants will be treated with RXC004. RXC004 capsules will be taken orally daily while fasting. Participants will also commence treatment with Denosumab, as an injection once a month.
Participants will be regularly assessed throughout the study in order to monitor safety and tumour response.
Conditions
This trial is treating people with pancreatic cancer that is RNF43+ and is locally advanced, unresectable or metastatic
Eligibility
Inclusion
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
Exclusion
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
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You are able to swallow medication by mouth.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Australian Genomic Cancer Medicine Centre Ltd t/a Omico
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
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