Spots Global Cancer Trial Database for BKM120 as Second-line Therapy for Advanced Endometrial Cancer
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Trial Identification
Brief Title: BKM120 as Second-line Therapy for Advanced Endometrial Cancer
Official Title: A Phase II, Single-arm Study of Orally Administered BKM120 as Second-line Therapy in Patients With Advanced Endometrial Carcinoma
Study ID: NCT01289041
Conditions
Interventions
Study Description
Brief Summary: This is a prospective multi-center, open-label, single arm, Phase II study to investigate the safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose disease progressed on or after a first-line antineoplastic treatment. Patients will receive BKM120 orally at a dose of 100 mg/day. Availability of tumor specimen (either archival tissue or a fixed fresh biopsy) is mandatory for assessment of the PI3K (Phosphatidylinositol 3 Kinase (PI3K) pathway activation status.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
St. Joseph's Hospital & Medical Center St Joseph's, Phoenix, Arizona, United States
Highlands Oncology Group Dept of Highlands Oncology Grp, Fayetteville, Arkansas, United States
Morristown Memorial Hospital MMH, Morristown, New Jersey, United States
Carolinas HealthCare Systems Blumenthal Cancer Center, Charlotte, North Carolina, United States
University of Oklahoma Health Sciences Center OU Health, Oklahoma City, Oklahoma, United States
Sarah Cannon Research Institute SCRI (2), Nashville, Tennessee, United States
Texas Oncology, P.A. Austin, Bedford, Texas, United States
South Texas Oncology and Hematology, PA South Tex Onc, San Antonio, Texas, United States
Cancer Care Northwest CC Northwest- Spokane South(3), Spokane, Washington, United States
Novartis Investigative Site, Parkville, Victoria, Australia
Novartis Investigative Site, Leuven, , Belgium
Novartis Investigative Site, Liege, , Belgium
Novartis Investigative Site, Wilrijk, , Belgium
Novartis Investigative Site, Rio de Janeiro, RJ, Brazil
Novartis Investigative Site, Vancouver, British Columbia, Canada
Novartis Investigative Site, Hamilton, Ontario, Canada
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Le Mans Cedex, , France
Novartis Investigative Site, Lyon Cedex, , France
Novartis Investigative Site, Nice Cedex 2, , France
Novartis Investigative Site, Toulouse Cedex 9, , France
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Köln, , Germany
Novartis Investigative Site, Mainz, , Germany
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Aviano, PN, Italy
Novartis Investigative Site, Roma, RM, Italy
Novartis Investigative Site, Bologna, , Italy
Novartis Investigative Site, Napoli, , Italy
Novartis Investigative Site, Nagoya, Aichi, Japan
Novartis Investigative Site, Chuo-ku, Tokyo, Japan
Novartis Investigative Site, Minato-ku, Tokyo, Japan
Novartis Investigative Site, Warszawa, , Poland
Novartis Investigative Site, St. Petersburg, , Russian Federation
Novartis Investigative Site, Singapore, , Singapore
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain
Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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