RX-5902 Treatment of Subjects With Triple Negative Breast Cancer

Solid Tumor Clinical Trial

Official title:

A Multi-Center, Dose Finding, Open Label, Phase 1 Study of RX-5902 in Subjects With Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02003092
• Other study ID #: RX-5902-P1-01
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: August 2013
• Est. completion date: November 2019

Study information

• Verified date: January 2020
• Source: Rexahn Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: November 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Solid Tumor
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• RX-5902
escalating doses (mg)

Locations

Country	Name	City	State
United States	Rexahn site	Arlington	Virginia
United States	Rexahn Site	Aurora	Colorado
United States	Rexahn site	Chicago	Illinois
United States	Rexahn Site	Detroit	Michigan
United States	Rexahn Site	Greenville	South Carolina
United States	Rexahn Site	Hackensack	New Jersey
United States	Rexahn Site	New York	New York
United States	Rexahn site	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Rexahn Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	phosphorylated P68 by IHC		baseline and 8 weeks
Other	Tumor burden response (Phase 2)		Baseline and at 4, 8, 12, 16 and 24 weeks
Primary	Incidence of dose limiting toxicities (DLTs) (Phase 1)		after 4 weeks of treatment with RX-5902
Primary	Progression free survival rate and/or overall clinical response rate (Phase 2)		16 weeks of treatment with RX-5902
Secondary	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
Secondary	Changes in tumor size mm		baseline and 24 weeks
Secondary	Time to progression (Phase 2)		Baseline and at 4, 8, 12, 16 and 24 weeks
Secondary	Duration of response (Phase 2)		Baseline and at 4, 8, 12, 16 and 24 weeks
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		6 months