RX-5902 Treatment of Subjects With Triple Negative Breast Cancer

NCT02003092 | Terminated Phase 1 DMC

• 1 other identifier: RX-5902-P1-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 8

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.

Conditions

Solid Tumor; Triple Negative Breast Cancer

Keywords

Metastatic; Rexahn; Phase 1; Triple Negative Breast Cancer; Phase 2; Relapsed

Outcome Measures

Primary Outcomes (2)

• Incidence of dose limiting toxicities (DLTs) (Phase 1)

  after 4 weeks of treatment with RX-5902

• Progression free survival rate and/or overall clinical response rate (Phase 2)

  16 weeks of treatment with RX-5902

Secondary Outcomes (5)

• Area under the plasma concentration versus time curve (AUC) of RX-5902

  predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8 hrs after the first dose

• Changes in tumor size mm

  baseline and 24 weeks

• Time to progression (Phase 2)

  Baseline and at 4, 8, 12, 16 and 24 weeks

• Duration of response (Phase 2)

  Baseline and at 4, 8, 12, 16 and 24 weeks

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  6 months

Other Outcomes (2)

• phosphorylated P68 by IHC

  baseline and 8 weeks

• Tumor burden response (Phase 2)

  Baseline and at 4, 8, 12, 16 and 24 weeks

Study Arms (1)

RX-5902

EXPERIMENTAL

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

Interventions

RX-5902 DRUG

escalating doses (mg)

Also known as: Supinoxin™

RX-5902

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rexahn Pharmaceuticals, Inc.: lead

Study Sites (8)

Rexahn site

Tucson, Arizona, 85724, United States

Location

Rexahn Site

Aurora, Colorado, 80045, United States

Location

Rexahn site

Chicago, Illinois, 60637, United States

Location

Rexahn Site

Detroit, Michigan, 48202, United States

Location

Rexahn Site

Hackensack, New Jersey, 07601, United States

Location

Rexahn Site

New York, New York, 10065, United States

Location

Rexahn Site

Greenville, South Carolina, 29605, United States

Location

Rexahn site

Arlington, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Neoplasm Metastasis; Recurrence

Interventions

RX-5902

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Ely Benaim, MD

  Rexahn Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: December 6, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2019
• Study Completion: November 1, 2019
• Last Updated: January 6, 2020

Record last verified: 2020-01

Locations

US (8)