A Study of RX108 in Patients With Locally Advanced or Metastatic Solid Tumors
- Registration Number
- NCT03646071
- Lead Sponsor
- NeuPharma, Inc.
- Brief Summary
RX108 is a novel, potent, small-molecule inhibitor of Na+/K+-ATPase. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of RX108 in patients with locally advanced or metastatic solid tumors.
- Detailed Description
This is a open-label, two-part study comprised of a dose escalation part and a dose expansion part. In the dose escalation part, RX108 will be administered in ascending doses to evaluate the safety and tolerability of RX108 and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). The dose expansion part will assess the safety, pharmacokinetics, and efficacy of RX108 at the RP2D.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- Histologically confirmed locally advanced or metastatic cancer that has failed all systemic therapies known to confer clinical benefit
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Minimum age of 18 years
- Adequate hematologic, hepatic and renal function
- Written Informed Consent
- Must agree to use adequate contraception (females and males)
- History of certain cardiac abnormalities
- History of inadequate pulmonary function
- Symptomatic brain metastasis
- Treatment with prohibited medications
- Known contra-indication to digoxin
- Treatment with any unapproved therapies for cancer, or any other anti-cancer therapy within 3 weeks
- Any toxicity related to prior treatment must have resolved to Grade 1 or less, with the exception of alopecia
- Clinically significant active infection requiring systemic antibiotic treatment
- Females who are pregnant or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation Phase RX108 The Dose-Escalation Phase will employ a standard 3+3 algorithm to investigate ascending dose cohorts of RX108. Dose Expansion Phase RX108 In the Expansion Phase, subjects will receive RX108 at the maximum tolerated dose.
- Primary Outcome Measures
Name Time Method Part 2: Incidence of adverse events (AEs) and serious adverse events (SAEs). Day 1 to 30 days post last dose The incidence of adverse events (AEs) and serious adverse events (SAEs) for each cohort dose will be assessed using CTCAE v 5.0.
Part 1: Maximum tolerated dose (MTD) of RX108 Day 1 to 30 All patients treated with RX108 across all dosing levels will have safety assessed in order to determine the MTD.
- Secondary Outcome Measures
Name Time Method Elimination half-life (T1/2) Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 Pharmacokinetics parameter
Systemic clearance (CL) Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 Pharmacokinetics parameter
Area under the plasma concentration-time curve (AUC) Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 Pharmacokinetics parameter
Maximum observed plasma concentration (Cmax) of RX108 Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 Pharmacokinetics parameter
Time to reach maximum concentration (Tmax) Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 Pharmacokinetics parameter
Response rate (per RECIST v1.1) Screening and every 2 cycles for the first 6 cycles and every 3 cycles thereafter (each cycle is 28 days), assessed up to 24 months. Evaluate the preliminary efficacy of RX108 in subjects with locally advanced or metastatic solid tumors (subjects with measurable disease in Part 2).
Trial Locations
- Locations (2)
Cedars-Sinai
🇺🇸Los Angeles, California, United States
University of Texas at MD Anderson Cancer Center
🇺🇸Houston, Texas, United States