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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.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 1, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : September 2020
Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of RX108 [ Time Frame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 ]
    Pharmacokinetics parameter

  2. Time to reach maximum concentration (Tmax) [ Time Frame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 ]
    Pharmacokinetics parameter

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

  4. Elimination half-life (T1/2) [ Time Frame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 ]
    Pharmacokinetics parameter

  5. Systemic clearance (CL) [ Time Frame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 ]
    Pharmacokinetics parameter

  6. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646071


Contacts
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Contact: Lyon Gleich, MD (513) 579-9911 ext 12400 l.gleich@medpace.com

Locations
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United States, California
Cedars-Sinai Recruiting
Los Angeles, California, United States, 90048
Contact: Vanessa Cajahuaringa    310-967-2795    vanessa.cajahuaringa@cshs.org   
Principal Investigator: Monica Mita, MD         
United States, Texas
University of Texas at MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Lidong Liu, PhD       lliu8@mdanderson.org   
Principal Investigator: Siqing Fu, MD         
Sponsors and Collaborators
NeuPharma, Inc.
Investigators
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Study Director: Lyon Gleich, MD Medpace, Inc.
More Information
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Responsible Party: NeuPharma, Inc.
ClinicalTrials.gov Identifier: NCT03646071    
Other Study ID Numbers: NP-102
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: To be determined.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NeuPharma, Inc.:
Locally Advanced
Metastatic
Solid Tumor
Additional relevant MeSH terms:
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Neoplasms