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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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