Clinical trial NCT02003092: 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
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Solid Tumor
Triple Negative Breast Cancer
Keywords: Metastatic
Rexahn
Phase 1
Triple Negative Breast Cancer
Phase 2
Relapsed
Lead sponsor: Rexahn Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of dose limiting toxicities (DLTs) (Phase 1)
timeFrame: after 4 weeks of treatment with RX-5902
measure: Progression free survival rate and/or overall clinical response rate (Phase 2)
timeFrame: 16 weeks of treatment with RX-5902
Secondary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of RX-5902
timeFrame: predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8 hrs after the first dose
measure: Changes in tumor size mm
timeFrame: baseline and 24 weeks
measure: Time to progression (Phase 2)
timeFrame: Baseline and at 4, 8, 12, 16 and 24 weeks
measure: Duration of response (Phase 2)
timeFrame: Baseline and at 4, 8, 12, 16 and 24 weeks
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 6 months
Other outcomes:
measure: phosphorylated P68 by IHC
timeFrame: baseline and 8 weeks
measure: Tumor burden response (Phase 2)
timeFrame: Baseline and at 4, 8, 12, 16 and 24 weeks
Locations:
city: Tucson
country: United States
facility: Rexahn site
state: Arizona
city: Aurora
country: United States
facility: Rexahn Site
state: Colorado
city: Chicago
country: United States
facility: Rexahn site
state: Illinois
city: Detroit
country: United States
facility: Rexahn Site
state: Michigan
city: Hackensack
country: United States
facility: Rexahn Site
state: New Jersey
city: New York
country: United States
facility: Rexahn Site
state: New York
city: Greenville
country: United States
facility: Rexahn Site
state: South Carolina
city: Arlington
country: United States
facility: Rexahn site
state: Virginia
Study officials:
affiliation: Rexahn Pharmaceuticals, Inc.
name: Ely Benaim, MD
role: STUDY_DIRECTOR
References: