NCT02003092

RX-5902 Treatment of Subjects With Triple Negative Breast Cancer

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Rexahn Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor
• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	RX-5902	escalating doses (mg)

Timeline

• Start date: 2013-08-01
• Primary completion: 2019-10-01
• Completion: 2019-11-01
• First posted: 2013-12-06
• Last updated: 2020-01-06

Locations

8 sites across 1 country: United States