Study of Safety and Efficacy of Alpelisib With Everolimus or Alpelisib With Everolimus and Exemestane in Advanced Breast Cancer Patients, Renal Cell Cancer and Pancreatic Tumors

NCT02077933 ↗

Phase 1 Completed 79 enrolled Novartis Pharmaceuticals

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Dose escalation part: to determine the highest dose of alpelisib administered on a daily basis when given in combination with daily everolimus or in combination with daily everolimus and exemestane. Dose expansion part: To describe safety and tolerability of the alpelisib and everolimus or alpelisib, everolimus and exemestane combinations.

Timeline

Start: 2014-05-14
Primary completion: 2019-04-12
Completion: 2019-04-12

Publications

Fankhauser M, Bechmann N, Lauseker M, Goncalves J, Favier J, Klink B, William D, Gieldon L, Maurer J, Spottl G, Rank P, Knosel T, Orth M, Ziegler CG, Aristizabal Prada ET, Rubinstein G, Fassnacht M, Spitzweg C, Grossman AB, Pacak K, Beuschlein F, Bornstein SR, Eisenhofer G, Auernhammer CJ, Reincke M, Nolting S. Synergistic Highly Potent Targeted Drug Combinations in Different Pheochromocytoma Models Including Human Tumor Cultures. Endocrinology. 2019 Nov 1;160(11):2600-2617. doi: 10.1210/en.2019-00410.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alpelisib	Small molecule	200 mg	Oral
Subject	Alpelisib	Small molecule	250 mg	Oral
Subject	Alpelisib	Small molecule	300 mg	Oral
Subject	Everolimus	Small molecule	2.5 mg	Oral
Subject	Exemestane	Small molecule	25 mg	Oral

Study of Safety and Efficacy of Alpelisib With Everolimus or Alpelisib With Everolimus and Exemestane in Advanced Breast Cancer Patients, Renal Cell Cancer and Pancreatic Tumors

Summary

Timeline

Publications

Drugs

Indications