Clinical Trials /

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

NCT03646071

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of RX108 in Patients With Locally Advanced or Metastatic Solid Tumors
  • 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 IDs

  • ORG STUDY ID: NP-102
  • NCT ID: NCT03646071

Conditions

  • Locally Advanced Solid Tumors
  • Metastatic Solid Tumors

Interventions

DrugSynonymsArms
RX108Dose Escalation Phase

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Dose Escalation PhaseExperimentalThe Dose-Escalation Phase will employ a standard 3+3 algorithm to investigate ascending dose cohorts of RX108.
  • RX108
Dose Expansion PhaseExperimentalIn the Expansion Phase, subjects will receive RX108 at the maximum tolerated dose.
  • RX108

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Part 1: Maximum tolerated dose (MTD) of RX108
Time Frame:Day 1 to 30
Safety Issue:
Description:All patients treated with RX108 across all dosing levels will have safety assessed in order to determine the MTD.

Secondary Outcome Measures

Measure:Maximum observed plasma concentration (Cmax) of RX108
Time Frame:Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
Safety Issue:
Description:Pharmacokinetics parameter
Measure:Time to reach maximum concentration (Tmax)
Time Frame:Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
Safety Issue:
Description:Pharmacokinetics parameter
Measure:Area under the plasma concentration-time curve (AUC)
Time Frame:Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
Safety Issue:
Description:Pharmacokinetics parameter
Measure:Elimination half-life (T1/2)
Time Frame:Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
Safety Issue:
Description:Pharmacokinetics parameter
Measure:Systemic clearance (CL)
Time Frame:Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8
Safety Issue:
Description:Pharmacokinetics parameter
Measure:Response rate (per RECIST v1.1)
Time Frame: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.
Safety Issue:
Description:Evaluate the preliminary efficacy of RX108 in subjects with locally advanced or metastatic solid tumors (subjects with measurable disease in Part 2).

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:NeuPharma, Inc.

Trial Keywords

  • Locally Advanced
  • Metastatic
  • Solid Tumor

Last Updated