RX-5902 Treatment of Subjects With Triple Negative Breast Cancer
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02003092 |
Recruitment Status :
Active, not recruiting
First Posted : December 6, 2013
Last Update Posted : September 10, 2019
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Condition or disease | Intervention/treatment | Phase |
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Solid Tumor Triple Negative Breast Cancer | Drug: RX-5902 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multi-Center, Dose Finding, Open Label, Phase 1 Study of RX-5902 in Subjects With Advanced or Metastatic Solid Tumors |
Study Start Date : | August 2013 |
Estimated Primary Completion Date : | October 2019 |
Estimated Study Completion Date : | November 2019 |

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.
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Drug: RX-5902
escalating doses (mg)
Other Name: Supinoxin™ |
- Incidence of dose limiting toxicities (DLTs) (Phase 1) [ Time Frame: 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 ]
- 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 ]
- Changes in tumor size mm [ Time Frame: baseline and 24 weeks ]
- Time to progression (Phase 2) [ Time Frame: 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 ]
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 6 months ]
- phosphorylated P68 by IHC [ Time Frame: baseline and 8 weeks ]
- Tumor burden response (Phase 2) [ Time Frame: Baseline and at 4, 8, 12, 16 and 24 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT02003092
United States, Arizona | |
Rexahn site | |
Tucson, Arizona, United States, 85724 | |
United States, Colorado | |
Rexahn Site | |
Aurora, Colorado, United States, 80045 | |
United States, Illinois | |
Rexahn site | |
Chicago, Illinois, United States, 60637 | |
United States, Michigan | |
Rexahn Site | |
Detroit, Michigan, United States, 48202 | |
United States, New Jersey | |
Rexahn Site | |
Hackensack, New Jersey, United States, 07601 | |
United States, New York | |
Rexahn Site | |
New York, New York, United States, 10065 | |
United States, South Carolina | |
Rexahn Site | |
Greenville, South Carolina, United States, 29605 | |
United States, Virginia | |
Rexahn site | |
Arlington, Virginia, United States, 22031 |
Study Director: | Ely Benaim, MD | Rexahn Pharmaceuticals, Inc. |
Responsible Party: | Rexahn Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT02003092 History of Changes |
Other Study ID Numbers: |
RX-5902-P1-01 |
First Posted: | December 6, 2013 Key Record Dates |
Last Update Posted: | September 10, 2019 |
Last Verified: | September 2019 |
Metastatic Rexahn Phase 1 |
Triple Negative Breast Cancer Phase 2 Relapsed |
Breast Neoplasms Triple Negative Breast Neoplasms Neoplasms by Site |
Neoplasms Breast Diseases Skin Diseases |