drugset / Trial / NCT01485874

Doxorubicin + BIBF 1120 in Patients for Ovarian Cancer

NCT01485874

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this trial is to determine whether BIBF 1120 can be safely combined with pegylated liposomal doxorubicin (phase I), and to determine the clinical activity of the combination in patients with platinum-resistant ovarian cancer (phase II).

Timeline

Start
2011-11
Primary completion
2015-12
Completion
2015-12

Publications

  • Background Maria Creselda deLeon, Alesha Arnold, Emma Caroline Rossi, Jamie Case, Cynthia Johnson, Yan Zeng, Daniela Matei. Phase I trial of pegylated liposomal doxorubicin in combination with BIBF 1120 (nintedanib) in platinum-resistant ovarian cancer: Hoosier Oncology Group GYN10-149. J Clin Oncol 32:5s, 2014 (suppl; abstr 5541^)

Drugs

EvaluationDrugModalityDoseRoute
Subject Nintedanib Small molecule 100 mg Oral
Subject Nintedanib Small molecule 150 mg Oral
Subject Nintedanib Small molecule 200 mg Oral
Background Doxorubicin Other / unclassified 40 mg/m2 Intravenous

Indications