RX-5902 Treatment of Subjects With Triple Negative Breast Cancer

Sponsor

Rexahn Pharmaceuticals, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT02003092

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

2.3

Patients Per Site

Patients Per Site Per Month

Study Details

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.

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

Study Type:

Interventional

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 :

Aug 1, 2013

Actual Primary Completion Date :

Oct 1, 2019

Actual Study Completion Date :

Nov 1, 2019

Arms and Interventions

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 Names: Supinoxin™

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 Names:

Supinoxin™

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Outcome Measures

phosphorylated P68 by IHC [baseline and 8 weeks]
Tumor burden response (Phase 2) [Baseline and at 4, 8, 12, 16 and 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rexahn site	Tucson	Arizona	United States	85724
2	Rexahn Site	Aurora	Colorado	United States	80045
3	Rexahn site	Chicago	Illinois	United States	60637
4	Rexahn Site	Detroit	Michigan	United States	48202
5	Rexahn Site	Hackensack	New Jersey	United States	07601
6	Rexahn Site	New York	New York	United States	10065
7	Rexahn Site	Greenville	South Carolina	United States	29605
8	Rexahn site	Arlington	Virginia	United States	22031