A Study of RX108 in Patients With Locally Advanced or Metastatic Solid Tumors

Metastatic Solid Tumors Clinical Trial

Official title:

A Phase 1, Open-label Study of the Safety, Pharmacokinetics and Efficacy of RX108 in Patients With Locally Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03646071
• Other study ID #: NP-102
• Status: Recruiting
• Phase: Phase 1
• Start date: August 1, 2018
• Est. completion date: December 2023

Study information

• Verified date: April 2022
• Source: NeuPharma, Inc.
• Contact: Lyon Gleich, MD
• Phone: (513) 579-9911
• Email: l.gleich[@]medpace.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Locally Advanced Solid Tumors
• Metastatic Solid Tumors
• Neoplasms

Intervention

Drug:
• RX108
RX108

Locations

Country	Name	City	State
United States	University of Texas at MD Anderson Cancer Center	Houston	Texas
United States	Cedars-Sinai	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
NeuPharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Maximum tolerated dose (MTD) of RX108	All patients treated with RX108 across all dosing levels will have safety assessed in order to determine the MTD.	Day 1 to 30
Primary	Part 2: Incidence of adverse events (AEs) and serious adverse events (SAEs).	The incidence of adverse events (AEs) and serious adverse events (SAEs) for each cohort dose will be assessed using CTCAE v 5.0.	Day 1 to 30 days post last dose
Secondary	Maximum observed plasma concentration (Cmax) of RX108	Pharmacokinetics parameter	Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
Secondary	Time to reach maximum concentration (Tmax)	Pharmacokinetics parameter	Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
Secondary	Area under the plasma concentration-time curve (AUC)	Pharmacokinetics parameter	Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
Secondary	Elimination half-life (T1/2)	Pharmacokinetics parameter	Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
Secondary	Systemic clearance (CL)	Pharmacokinetics parameter	Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
Secondary	Response rate (per RECIST v1.1)	Evaluate the preliminary efficacy of RX108 in subjects with locally advanced or metastatic solid tumors (subjects with measurable disease in Part 2).	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.