RX-5902 Treatment of Subjects With Triple Negative Breast Cancer

January 3, 2020 updated by: Rexahn Pharmaceuticals, Inc.

A Multi-Center, Dose Finding, Open Label, Phase 1 Study of RX-5902 in Subjects With Advanced or Metastatic Solid Tumors

The purpose of this Phase 2 portion of the study is to use the dose and schedule of RX-5902 identified in the phase 1 to treat subjects with triple negative breast cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

In this dose-finding, open-label, single-agent study of RX-5902, subjects will be treated for up to 6 cycles of therapy. RX-5902 will be administered orally daily for 3 weeks followed by 1 week of rest in each cycle. All subjects will be followed for at least 30 days after the last dose of study agent for safety.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Rexahn Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Rexahn Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Rexahn Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Rexahn Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Rexahn Site
    • New York
      • New York, New York, United States, 10065
        • Rexahn Site
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Rexahn Site
    • Virginia
      • Arlington, Virginia, United States, 22031
        • Rexahn Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female who are 18 yrs or older
  • Histologically confirmed triple negative breast cancer that are refractory, intolerant, or ineligible to receive approved standard therapies
  • Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST)
  • Life expectancy of at least 3 months
  • Able to swallow capsules
  • Provide written informed consent

Exclusion Criteria:

  • Primary brain tumor or active brain metastasis
  • Not recovered to less than or equal to Grade 1 toxicities (except Grade 2 alopecia or neuropathy) associated with previous cancer therapies
  • Any other cancer treatments within 2 weeks of planned study treatment
  • History of any medical or psychiatric condition or addictive disorder, or lab abnormality that in the opinion of the investigator, may increase risks or may interfere with study participation or interpretation of study results
  • History of clinically significant GI bleed, intestinal obstruction, or GI perforation within 6 months of study dose
  • Uncontrolled diabetes
  • History of long QT syndrome or clinically significant cardiac arrhythmias (except stable atrial fibrillation)
  • Myocardial infarction within 6 months of study dose
  • Active infection requiring IV antibiotics within 2 weeks of study dose
  • History of Hepatitis B, C, or HIV
  • Use of potent inhibitor or inducer of CYP3A4/3A5 within 14 days of planned study treatment or expected requirement for use of such a drug during study
  • Use of a potent inhibitor or inducer of drug transporters or conjugating enzymes within 14 days prior to planned study treatment or expected requirement for use of such a drug during study
  • Receiving other investigational agents or not yet completed 30 days since completion of an investigational study
  • Pregnant, planning a pregnancy, or breast feeding
  • Male or female not willing to use adequate contraceptive precautions during the study period. Females must either be surgically sterile, post-menopausal for 12 months, or use a contraceptive approved by sponsor.
  • Unwilling or unable to provide written informed consent, comply with study requirements, or be available for follow-up assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RX-5902
RX-5902 will be taken daily for 4 weeks in each 4 week cycle. Subjects will be fasting for 8 hours before and food may be ingested approximately 3 hours after the dose has been administered.
Drug: RX-5902
escalating doses (mg)
Other Names:
  • Supinoxin™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of dose limiting toxicities (DLTs) (Phase 1)
Time Frame: after 4 weeks of treatment with RX-5902
after 4 weeks of treatment with RX-5902
Progression free survival rate and/or overall clinical response rate (Phase 2)
Time Frame: 16 weeks of treatment with RX-5902
16 weeks of treatment with RX-5902

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 6 months
6 months
Area under the plasma concentration versus time curve (AUC) of RX-5902
Time Frame: predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8 hrs after the first dose
predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8 hrs after the first dose
Changes in tumor size mm
Time Frame: baseline and 24 weeks
baseline and 24 weeks
Time to progression (Phase 2)
Time Frame: Baseline and at 4, 8, 12, 16 and 24 weeks
Baseline and at 4, 8, 12, 16 and 24 weeks
Duration of response (Phase 2)
Time Frame: Baseline and at 4, 8, 12, 16 and 24 weeks
Baseline and at 4, 8, 12, 16 and 24 weeks

Other Outcome Measures

Outcome Measure
Time Frame
phosphorylated P68 by IHC
Time Frame: baseline and 8 weeks
baseline and 8 weeks
Tumor burden response (Phase 2)
Time Frame: Baseline and at 4, 8, 12, 16 and 24 weeks
Baseline and at 4, 8, 12, 16 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rexahn Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

November 15, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 6, 2013

Study Record Updates

Last Update Posted (Actual)

January 6, 2020

Last Update Submitted That Met QC Criteria

January 3, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RX-5902-P1-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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