Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance

NCT01197170 ↗

Phase 1 Completed 277 enrolled M.D. Anderson Cancer Center

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical research study to find the highest tolerated dose of anastrozole alone or in combination with either everolimus (Afinitor), sorafenib (Nexavar), erlotinib (Tarceva), fulvestrant (Faslodex), or bevacizumab (Avastin) that can be given to patients with advanced cancer. The safety of these drug combinations will also be studied.

Timeline

Start: 2010-09-07
Primary completion: 2021-01-13
Completion: 2021-01-13

Publications

Wheler JJ, Moulder SL, Naing A, Janku F, Piha-Paul SA, Falchook GS, Zinner R, Tsimberidou AM, Fu S, Hong DS, Atkins JT, Yelensky R, Stephens PJ, Kurzrock R. Anastrozole and everolimus in advanced gynecologic and breast malignancies: activity and molecular alterations in the PI3K/AKT/mTOR pathway. Oncotarget. 2014 May 30;5(10):3029-38. doi: 10.18632/oncotarget.1799.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Anastrozole	Other / unclassified	1 mg	Oral
Subject	Bevacizumab	Monoclonal antibody	10 mg	Intravenous
Subject	Erlotinib	Small molecule	75 mg	Oral
Subject	Everolimus	Small molecule	5 mg	Oral
Subject	Sorafenib	Small molecule	200 mg	Oral

Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance

Summary

Timeline

Publications

Drugs

Indications