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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03646071
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
NeuPharma, Inc.

Tracking Information
First Submitted Date  ICMJE July 18, 2018
First Posted Date  ICMJE August 24, 2018
Last Update Posted Date November 8, 2019
Actual Study Start Date  ICMJE August 1, 2018
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2018)
  • Part 1: Maximum tolerated dose (MTD) of RX108 [ Time Frame: 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). [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2018)
  • Maximum observed plasma concentration (Cmax) of RX108 [ Time Frame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 ]
    Pharmacokinetics parameter
  • Time to reach maximum concentration (Tmax) [ Time Frame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 ]
    Pharmacokinetics parameter
  • Area under the plasma concentration-time curve (AUC) [ Time Frame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 ]
    Pharmacokinetics parameter
  • Elimination half-life (T1/2) [ Time Frame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 ]
    Pharmacokinetics parameter
  • Systemic clearance (CL) [ Time Frame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 ]
    Pharmacokinetics parameter
  • 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. ]
    Evaluate the preliminary efficacy of RX108 in subjects with locally advanced or metastatic solid tumors (subjects with measurable disease in Part 2).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of RX108 in Patients With Locally Advanced or Metastatic Solid Tumors
Official Title  ICMJE A Phase 1, Open-label Study of the Safety, Pharmacokinetics and Efficacy of RX108 in Patients With Locally Advanced or Metastatic Solid Tumors
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Locally Advanced Solid Tumors
  • Metastatic Solid Tumors
Intervention  ICMJE Drug: RX108
RX108
Study Arms  ICMJE
  • Experimental: Dose Escalation Phase
    The Dose-Escalation Phase will employ a standard 3+3 algorithm to investigate ascending dose cohorts of RX108.
    Intervention: Drug: RX108
  • Experimental: Dose Expansion Phase
    In the Expansion Phase, subjects will receive RX108 at the maximum tolerated dose.
    Intervention: Drug: RX108
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 22, 2018)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lyon Gleich, MD (513) 579-9911 ext 12400 l.gleich@medpace.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03646071
Other Study ID Numbers  ICMJE NP-102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: To be determined.
Responsible Party NeuPharma, Inc.
Study Sponsor  ICMJE NeuPharma, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lyon Gleich, MD Medpace, Inc.
PRS Account NeuPharma, Inc.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP