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

Sponsor

NeuPharma, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03646071

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced Solid Tumors Metastatic Solid Tumors	Drug: RX108	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 1, 2018

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose Escalation Phase The Dose-Escalation Phase will employ a standard 3+3 algorithm to investigate ascending dose cohorts of RX108.	Drug: RX108 RX108
Experimental: Dose Expansion Phase In the Expansion Phase, subjects will receive RX108 at the maximum tolerated dose.	Drug: RX108 RX108

Arm

Intervention/Treatment

Experimental: Dose Escalation Phase

The Dose-Escalation Phase will employ a standard 3+3 algorithm to investigate ascending dose cohorts of RX108.

Drug: RX108

RX108

Experimental: Dose Expansion Phase

In the Expansion Phase, subjects will receive RX108 at the maximum tolerated dose.

Drug: RX108

RX108

Outcome Measures

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
Area under the plasma concentration-time curve (AUC) [Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8]
Pharmacokinetics parameter
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
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai	Los Angeles	California	United States	90048
2	University of Texas at MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

NeuPharma, Inc.

Investigators

Study Director: Lyon Gleich, MD, Medpace, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NeuPharma, Inc.

ClinicalTrials.gov Identifier:

NCT03646071

Other Study ID Numbers:

NP-102

First Posted:

Aug 24, 2018

Last Update Posted:

Apr 13, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by NeuPharma, Inc.

Locally Advanced

Metastatic

Solid Tumor

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Apr 13, 2022