Trial summary: | This study will assess the efficacy and safety of RXC004 in individuals with advanced pancreatic cancer who have progressed following standard of care therapy. |
Status: | OPEN for Recruitment |
Trial identifier: | ACTRN12624000588594p |
Sponsor: | Australian Genomic Cancer Medicine Centre Ltd t/a Omico |
Phase: | II |
Diagnosis: | Locally advanced (Stage III) unresectable or Metastatic (Stage IV) pancreatic ductal adenocarcinoma |
Line of therapy: | Second-line |
Treatment: | RXC004 (Zamaporvint) oral monotherapy in combination with denosumab |
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Key inclusion criteria
- >=18 years of age at the time of signing the informed consent
- Ability to give written informed consent and capable of understanding the protocol requirements
- At least one lesion that is measurable by RECIST 1.1 at baseline (must not be chosen for the mandatory and optional biopsies)
- Mandatory biopsy at screening (must not be a target lesion for RECIST 1.1), optional biopsy at C1D15
- Adequate organ and marrow function
- WOCBP and partners of participants who are WOCBP must adhere to contraception requirements
- 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
- 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
- Patients must be enrolled and receive first dose of study treatment within 6 weeks of radiologically confirmed progression
- 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
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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 which in the investigator's opinion makes it undesirable for the patient to participate in the study
- Patients who have any history of an active other malignancy within 2 years of study entry
- Patients with known or suspected brain metastases
- 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
- 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 HIV, hepatitis B (HBV), or hepatitis C (HCV) infections
- Use of any live or live-attenuated vaccines against infectious diseases within 4 weeks of initiation of study treatment
- Mean resting corrected QTcF >470 ms
Porcupine P2EA
Locations: Epworth Richmond, Epworth Freemasons (East Melbourne), Epworth Eastern (Box Hill).
Epworth PI: A/Prof Sumitra Ananda
Jreissati Pancreatic Centre at Epworth
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General enquiries
Please contact us for more information on 03 9426 8880 or email [email protected]