drugset / Trial / NCT01205685

Endocrine Therapy + OSI-906 With or Without Erlotinib for Hormone-Sensitive Metastatic Breast Cancer

NCT01205685 ↗

Phase 2 Terminated 11 enrolled Vanderbilt-Ingram Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

Erlotinib attacks a part of cancer cells that helps them live and grow. Studies done in human beings show that this drug can make a difference in the way anti-estrogens work in hormone-sensitive breast cancers. OSI-906 attacks a different part of the cancer cell that helps them live and grow. Studies done in the laboratory show that OSI-906 can make a difference in the way anti-estrogens work in hormone-sensitive breast cancers.

Timeline

Start
2010-05
Primary completion
2011-07
Completion
2011-07

Outcome

Outcome not reported

Stopped: “PI closed study early, all patients experienced severe toxicities and progressed”

Drugs

EvaluationDrugModalityDoseRoute
Subject Erlotinib Small molecule 50 mg Oral
Subject Erlotinib Small molecule 75 mg Oral
Subject Erlotinib Small molecule 100 mg Oral
Subject linsitinib Small molecule 100 mg Oral
Subject linsitinib Small molecule 150 mg Oral
Background Goserelin Other / unclassified 3.6 mg Other
Background Letrozole Other / unclassified 2.5 mg Oral

Indications