Phase I study to evaluate Safety and Tolerability of RX108-A Tablets in Patients with advanced Cancer
A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of RX108-A Tablet in Patients with Locally Advanced or Metastatic Solid Tumors
NeuPharma Pty Ltd
20 participants
Jun 15, 2023
Interventional
Conditions
Summary
This study is investigating a new cancer treatment drug, RX108-A, to determine whether it is safe and effective for patients with locally advanced or metastatic solid tumors. Who is it for?: You may be eligible for this study if you are an adult aged 18 years or older and you have been diagnosed with locally advanced or metastatic solid tumors and you have failed at least one standard of care therapy, or you were intolerant to a standard of care therapy, or you have refused such treatment. Study details: This study will firstly enroll participants into a dose escalation study. Participants who choose to enroll in the escalation study will be assigned a specific number of tablets to take each day for 3 weeks, followed by a 1 week rest. Participants will be asked to keep a diary of any side effects that they experience while taking the experimental treatment, and may be asked to stop taking the tablets if they experience any severe side effects. Participants will also be asked to provide blood samples at 4 different times during their 3-week treatment cycle. New groups of participants will be enrolled to test each higher dose of the experimental treatment until the best tolerated dose is identified. After the best tolerated dose has been identified, a new group of up to 9 participants will be enrolled for the dose expansion study. Participants who choose to enroll in the expansion study will be assigned a specific number of tablets to take each day for 3 weeks, followed by a 1 week rest. Participants in this study will be asked to keep taking the tablets for 3-week cycles for up to 7 months, and will be asked to provide blood samples at different timepoints during their first three 3-week treatment cycles. It is hoped this research will determine the highest safe dose of RX108-A that reduces the growth of tumors in people with locally advanced or metastatic solid tumors. If this study finds that RX108-A is safe and effective, it may be expanded to a larger trial of people with locally advanced or metastatic solid tumors.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
RX108- A novel synthetic small-molecule inhibitor of Na+/K+ -ATPase. There are 2 parts to this study: Part 1, dose escalation; Part 2, dose expansion. Part 1 – Dose Escalation: The starting dose will be 0.5 mg of RX108-A Tablet once daily and subsequent dose escalation will proceed with dose increases of 25% to 100% between cohorts up to maximum dose of 5 mg/day (tentatively), based on the safety data. Dosing will be continued until the Maximum Tolerated Dose (MTD) or optimum biological dose (OBD) is reached to provide a Recommended Phase 2 Dose (RP2D). A tablet/tablets administered orally once daily for 3 weeks, followed by 1 week of rest. Drug tablet return and accountability will monitor adherence Part 2 – Dose Expansion: The expansion part will consist of patients with all solid tumors and up to an additional 6 to 9 patients treated at the RP2D. Part 2 will commence after RP2D (recommended phase 2 dose) is determined by the Safety Review Committee. As seen in Part 1, Part 2 will have a tablet/tablets administered orally once daily for 3 weeks, followed by 1 week of rest. Drug tablet return and accountability will be monitor adherence. The time from Screening to last visit for each patient will be approximately 7 months. Treatment cycles of 28 days then proceed to the next dose up, for up to 7 months.
Locations(2)
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ACTRN12623000307606