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

NCT03646071 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: NP-102
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Locally Advanced Solid Tumors; Metastatic Solid Tumors

Keywords

Locally Advanced; Metastatic; Solid Tumor

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Maximum observed plasma concentration (Cmax) of RX108

  Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8

• Time to reach maximum concentration (Tmax)

  Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8

• Area under the plasma concentration-time curve (AUC)

  Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8

• Elimination half-life (T1/2)

  Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8

• Systemic clearance (CL)

  Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8

Study Arms (2)

Dose Escalation Phase

EXPERIMENTAL

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

Drug: RX108

Dose Expansion Phase

EXPERIMENTAL

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

Drug: RX108

Interventions

RX108 DRUG

RX108

Dose Escalation Phase; Dose Expansion Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• NeuPharma, Inc.: lead

Study Sites (2)

Cedars-Sinai

Los Angeles, California, 90048, United States

RECRUITING

University of Texas at MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lyon Gleich, MD

  Medpace, Inc.

  STUDY DIRECTOR

Central Study Contacts

Lyon Gleich, MD

CONTACT

(513) 579-9911; l.gleich@medpace.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 24, 2018
• Study Start: August 1, 2018
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 13, 2022

Record last verified: 2022-04

Locations

US (2)