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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.

Tracking Information
First Submitted Date  ICMJE November 15, 2013
First Posted Date  ICMJE December 6, 2013
Last Update Posted Date January 6, 2020
Study Start Date  ICMJE August 2013
Actual Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2017)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
Incidence of dose limiting toxicities (DLTs) [ Time Frame: after 4 weeks of treatment with RX-5902 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
  • 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, 24 and 48 hrs after the first dose ]
  • Changes in tumor size mm [ Time Frame: baseline and 24 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: September 26, 2017)
  • 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 ]
Original Other Pre-specified Outcome Measures
 (submitted: December 3, 2013)
phosphorylated P68 by IHC [ Time Frame: baseline and 8 weeks ]
 
Descriptive Information
Brief Title  ICMJE RX-5902 Treatment of Subjects With Triple Negative Breast Cancer
Official Title  ICMJE A Multi-Center, Dose Finding, Open Label, Phase 1 Study of RX-5902 in Subjects With Advanced or Metastatic Solid Tumors
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor
  • Triple Negative Breast Cancer
Intervention  ICMJE Drug: RX-5902
escalating doses (mg)
Other Name: Supinoxin™
Study Arms  ICMJE 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.
Intervention: Drug: RX-5902
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 18, 2018)
18
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2013)
20
Actual Study Completion Date  ICMJE November 2019
Actual Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02003092
Other Study ID Numbers  ICMJE RX-5902-P1-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rexahn Pharmaceuticals, Inc.
Study Sponsor  ICMJE Rexahn Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ely Benaim, MD Rexahn Pharmaceuticals, Inc.
PRS Account Rexahn Pharmaceuticals, Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP