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RX-5902 Treatment of Subjects With Triple Negative Breast Cancer

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 : Terminated
First Posted : December 6, 2013
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
Rexahn Pharmaceuticals, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumor Triple Negative Breast Cancer Drug: RX-5902 Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
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
Actual Primary Completion Date : October 2019
Actual Study Completion Date : November 2019

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Arms and Interventions
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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 Name: Supinoxin™


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

Secondary Outcome Measures :
  1. 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 ]
  2. Changes in tumor size mm [ Time Frame: baseline and 24 weeks ]
  3. Time to progression (Phase 2) [ Time Frame: Baseline and at 4, 8, 12, 16 and 24 weeks ]
  4. Duration of response (Phase 2) [ Time Frame: Baseline and at 4, 8, 12, 16 and 24 weeks ]
  5. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 6 months ]

Other Outcome Measures:
  1. phosphorylated P68 by IHC [ Time Frame: baseline and 8 weeks ]
  2. Tumor burden response (Phase 2) [ Time Frame: Baseline and at 4, 8, 12, 16 and 24 weeks ]

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:

  • 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
Contacts and Locations
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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


Locations
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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
Sponsors and Collaborators
Rexahn Pharmaceuticals, Inc.
Investigators
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Study Director: Ely Benaim, MD Rexahn Pharmaceuticals, Inc.
More Information
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Responsible Party: Rexahn Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02003092    
Other Study ID Numbers: RX-5902-P1-01
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
Keywords provided by Rexahn Pharmaceuticals, Inc.:
Metastatic
Rexahn
Phase 1
 Triple Negative Breast Cancer
Phase 2
Relapsed
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases