Phase I study to evaluate Safety and Tolerability of RX108-A Tablets in Patients with advanced Cancer

Phase 1

Recruiting

• Conditions: ocally Advanced or Metastatic Solid Tumors; Locally Advanced or Metastatic Solid Tumors; Cancer - Any cancer

• Registration Number: ACTRN12623000307606
• Lead Sponsor: euPharma Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

A patient will be eligible for study participation if the patient meets all of the following criteria:
1.Signed Informed Consent Form.
2.18 years and over.
3.Patients with locally advanced or metastatic solid tumors that have failed at least one standard of care therapy or were intolerant to, or have refused such treatment, are eligible.
4.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5.Life expectancy of at least 3 months.
6.Must agree to use adequate contraception (females and males).

Exclusion Criteria

1. History of certain cardiac abnormalities
2. History of inadequate pulmonary function
3. Symptomatic brain metastasis
4. Treatment with prohibited medications
5. Known contra-indication to digoxin
6. Treatment with any unapproved therapies for cancer, or any other anti-cancer therapy within 3 weeks
7. Any toxicity related to prior treatment must have resolved to Grade 1 or less, except for alopecia
8. Clinically significant active infection requiring systemic antibiotic treatment
9. Females who are pregnant or breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of RX108-A Tablet administered orally once daily for 3 weeks followed by 1 week rest to patients with locally advanced or metastatic solid tumors via Dose-limiting toxicities. Safety and tolerability is assessed through ongoing physical exams, clinical laboratory tests (blood and urine samples), ECG, and evaluation of ECOG performance status during study visits.<br>[ Days 1, 8, 15 and 21 after being enrolled in the study and taking RX108-A<br>];To determine the Maximum Tolerated Dose (MTD) of RX108-A Tablet. The MTD is defined as the dose below the level at which > 33% of patients experience a dose-limiting toxicity (DLT) in a given cohort, and there will be at least six patients enrolled at the MTD to define safety. Toxicities will be assessed by physical exams, clinical laboratory tests (blood and urine samples), ECG, evaluation of ECOG performance status, and other tests if necessary.<br><br>[ Baseline, 30 days and 7 months after intervention commencement]