drugset / Trial / NCT01697293

PTX-200, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide in Treating Patients With Stage IIB-IV Breast Cancer

NCT01697293

NaSingle-groupOpen-labelTreatment

Summary

This phase I/II trial studies the side effects and the best dose of triciribine phosphate when given together with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide and to see how well they work in treating patients with stage IIB-IV breast cancer. Triciribine phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, doxorubicin hydrochloride, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving triciribine phosphate with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide may be a better treatment for breast cancer.

Timeline

Start
2012-01
Primary completion
2020-06
Completion
2020-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Triciribine Unknown Intravenous
Background Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 60 mg/m2 Intravenous
Background Paclitaxel Small molecule 80 mg/m2 Intravenous