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Spots Global Cancer Trial Database for Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Clinical Development Senior Vice President

Affiliation: Puma Biotechnology, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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