None listed
Conditions
Brief summary
This study will assess the anti-cancer activity of RXC004 given alone in participants with advanced pancreatic cancer whose cancer has worsened following therapy with current standard of care. You may be eligible for this study if you are participating in the Cancer Molecular Screening and Therapeutics (MoST) Program (ACTRN12616000908437) and have RNF43-positive pancreatic ductal adenocarcinoma that has progressed following therapy with current standard of care. All participants will be treated with RXC004. RXC004 capsule strengths are 0.5 mg and 1.0 mg capsules to be taken at a dose of 2mg daily, taken orally and fasted. Participants will be regularly assessed throughout the study in order to monitor safety and tumour response. It is hoped that this study will help increase treatment options for patients with advanced pancreatic cancer.
Interventions
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,
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.
Sponsors
Australian Genomic Cancer Medicine Centre Ltd t/a Omico
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed