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RX-5902 Treatment of Subjects With Triple Negative Breast Cancer

Primary Purpose

Solid Tumor, Triple Negative Breast Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RX-5902
Sponsored by
Rexahn Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor focused on measuring Metastatic, Rexahn, Phase 1, Triple Negative Breast Cancer, Phase 2, Relapsed

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rexahn site
  • Rexahn Site
  • Rexahn site
  • Rexahn Site
  • Rexahn Site
  • Rexahn Site
  • Rexahn Site
  • Rexahn site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RX-5902

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of dose limiting toxicities (DLTs) (Phase 1)
Progression free survival rate and/or overall clinical response rate (Phase 2)

Secondary Outcome Measures

Area under the plasma concentration versus time curve (AUC) of RX-5902
Changes in tumor size mm
Time to progression (Phase 2)
Duration of response (Phase 2)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Full Information

First Posted
November 15, 2013
Last Updated
January 3, 2020
Sponsor
Rexahn Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02003092
Brief Title
RX-5902 Treatment of Subjects With Triple Negative Breast Cancer
Official Title
A Multi-Center, Dose Finding, Open Label, Phase 1 Study of RX-5902 in Subjects With Advanced or Metastatic Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Study Start Date
August 2013 (undefined)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rexahn Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Triple Negative Breast Cancer
Keywords
Metastatic, Rexahn, Phase 1, Triple Negative Breast Cancer, Phase 2, Relapsed

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RX-5902
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
RX-5902
Other Intervention Name(s)
Supinoxin™
Intervention Description
escalating doses (mg)
Primary Outcome Measure Information:
Title
Incidence of dose limiting toxicities (DLTs) (Phase 1)
Time Frame
after 4 weeks of treatment with RX-5902
Title
Progression free survival rate and/or overall clinical response rate (Phase 2)
Time Frame
16 weeks of treatment with RX-5902
Secondary Outcome Measure Information:
Title
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
Title
Changes in tumor size mm
Time Frame
baseline and 24 weeks
Title
Time to progression (Phase 2)
Time Frame
Baseline and at 4, 8, 12, 16 and 24 weeks
Title
Duration of response (Phase 2)
Time Frame
Baseline and at 4, 8, 12, 16 and 24 weeks
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
phosphorylated P68 by IHC
Time Frame
baseline and 8 weeks
Title
Tumor burden response (Phase 2)
Time Frame
Baseline and at 4, 8, 12, 16 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ely Benaim, MD
Organizational Affiliation
Rexahn Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Rexahn site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Rexahn Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rexahn site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Rexahn Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Rexahn Site
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Rexahn Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Rexahn Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Rexahn site
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States

12. IPD Sharing Statement

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RX-5902 Treatment of Subjects With Triple Negative Breast Cancer

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