BKM120 as Second-line Therapy for Advanced Endometrial Cancer

Completed · Phase 2

Conditions studied: Advanced Endometrial Cancer

In brief

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.

Key facts

Study ID

NCT01289041

Run by

Novartis Pharmaceuticals

People needed

70

Starts

2011-02-01

Expected to finish

2014-03-01

Last updated by the study team

2019-05-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
• histologically confirmed diagnosis of advanced endometrial carcinoma with available tissue specimen for identification of PI3K pathway activation (archival tissue or a fixed fresh biopsy)
• one prior line of antineoplastic treatment with a cytotoxic agent
• objective progression of disease after prior treatment and at least one measurable lesion as per RECIST criteria
• adequate bone marrow and organ function

You may not qualify if…

• previous treatment with PI3K and/or mTOR inhibitors
• symptomatic CNS metastases
• concurrent malignancy or malignancy within 3 years of study enrollment
• Active mood disorder as judged by investigator or medically documented history of mood disorder (e.g. major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, etc.), ≥ CTCAE grade 3 anxiety
• pelvic and/or para-aortic radiotherapy ≤ 28 days prior to enrollment in the study
• poorly controlled diabetes mellitus (HbA1c > 8 %)
• history of cardiac dysfunction or active cardiac disease as specified in the protocol
• impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• 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 — Liège, Belgium
• Novartis Investigative Site — Wilrijk, Belgium
• Novartis Investigative Site — Rio de Janeiro, Rio de Janeiro, 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, France
• Novartis Investigative Site — Lyon, France
• Novartis Investigative Site — Nice, France
• Novartis Investigative Site — Toulouse, France
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Cologne, Germany

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.