The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer
Official Title: A Phase 2 Study of Neratinib and Neratinib Plus Temsirolimus in Patients With Non-Small Cell Lung Cancer Carrying Known HER2 Activating Mutations
Study ID: NCT01827267
Brief Summary: This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter, multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus combination therapy in patients with non-small cell lung cancer (NSCLC) who have documented somatic HER2 mutations.
Detailed Description: This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter, multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus combination therapy in patients with NSCLC and documented somatic HER2 mutations. Patients randomized at study entry into 1 of 2 treatment arms: * Arm A: neratinib 240 mg orally once daily * Arm B: neratinib 240 mg orally once daily plus temsirolimus 8 mg once weekly by intravenous (IV) infusion In the case of disease progression, patients initially assigned to neratinib monotherapy arm given option to add temsirolimus 8 mg IV once weekly. Patients on combination therapy given option to dose-escalate temsirolimus to 15 mg/week at the end of first cycle of treatment, if well tolerated and at the physician's discretion. If neratinib 240 mg/day plus temsirolimus 15 mg/week dose not well tolerated, patient subsequently dose reduced back to neratinib 240 mg/day plus temsirolimus 8 mg/week. Dosing continuous on nominal 3-week cycles until evidence of progressive disease, unacceptable toxicity, or patient withdrawal of consent. Disease measured radiographically at baseline and every 6 weeks until disease progression or withdrawal from the study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope, Duarte, California, United States
University of California Los Angeles, Santa Monica, California, United States
University of Colorado, Aurora, Colorado, United States
Moffitt Cancer Center, Tampa, Florida, United States
Johns Hopkins, Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Massachusettes General Hospital, Boston, Massachusetts, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Ohio State University, Columbus, Ohio, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Vanderbilt University, Nashville, Tennessee, United States
UT Southwestern Medical Center, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
CHU de Grenoble Hopital Albert Michallon, Grenoble, , France
CHRU de Lille - Hopital Calmette, Lille, , France
Hopital Nord, Marseille, , France
Hopitaux universitaires de Strasbourg Nouvel Hopital Civil, Strasbourg, , France
CHU de Toulous Hopital Larre, Toulouse, , France
Institut Gustave Roussy, Villejuif, , France
Name: Clinical Development Senior Vice President
Affiliation: Puma Biotechnology, Inc.
Role: STUDY_DIRECTOR