BKM120 for Patients With PI3K-activated Tumors

Completed · Phase 2

Conditions studied: PI3K Pathway Activated Tumors

In brief

The purpose of this signal seeking study was is to determine whether treatment with BKM120 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.

Key facts

Study ID

NCT01833169

Run by

Novartis Pharmaceuticals

People needed

146

Starts

2013-03-29

Expected to finish

2016-09-26

Last updated by the study team

2018-10-19

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient had a confirmed diagnosis of a solid tumor or hematological malignancy with the exception of endometrial cancer, glioblastoma, nonsmall cell lung cancer, prostate cancer or breast cancer.
• Patient's tumor was evaluated and pre-identified to have activation of the PI3K pathway, at a CLIA certified laboratory
• Patient must have received at least one prior treatment for recurrent metastatic and /or locally advanced disease and for whom no standard therapy options was anticipated to result in a durable remission.
• Patient must have had progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines
• Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

You may not qualify if…

• Patient had received previous treatment with BKM120 Patient had symptomatic CNS metastases Patient had mood disorder as outlined in Section 5 Patient had received chemotherapy or other anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug.

Where it is running

• Arizona Oncology Associates PC- HAL — Sedona, Arizona, United States
• Highlands Oncology Group — Fayetteville, Arkansas, United States
• Sarcoma Oncology Center — Santa Monica, California, United States
• Rocky Mountain Cancer Centers RMCC - Aurora — Greenwood Village, Colorado, United States
• Whittingham Cancer Center Norwalk Hospital — Norwalk, Connecticut, United States
• Eastern Connecticut Hematology & Oncology Associates The Norwich Cancer Center — Norwich, Connecticut, United States
• Florida Cancer Specialists Dept of Oncology (2) — Fort Myers, Florida, United States
• Florida Hospital Cancer Institute FL Hosp. Cancer Instit. — Orlando, Florida, United States
• Florida Cancer Specialists — West Palm Beach, Florida, United States
• University Cancer & Blood Center, LLC — Athens, Georgia, United States
• Southeastern Regional Medical Center — Newnan, Georgia, United States
• Lurie Children's Hospital of Chicago Developmental Therapeutics — Chicago, Illinois, United States
• Cancer Care Specialists of Central Illinois — Decatur, Illinois, United States
• Illinois Cancer Care P.C. IL. Cancer Care — Peoria, Illinois, United States
• Illinois Cancer Care P.C. — Peoria, Illinois, United States
• Cancer Treatment Centers of America Southwestern Regional Med. Ctr — Schaumburg, Illinois, United States
• Northern Indiana Cancer Research Consortium No. Indiana Cancer Res. — South Bend, Indiana, United States
• University of Iowa Hospitals & Clinics Regulatory Contact 2 — Iowa City, Iowa, United States
• Eastern Maine Medical Center Research Center SC — Bangor, Maine, United States
• Mount Auburn Hospital — Cambridge, Massachusetts, United States
• Michigan Medicine University of Michigan Int. Medicine Oncology — Ann Arbor, Michigan, United States
• Cancer and Hematology Centers of West Michigan Dept. of Oncology — Grand Rapids, Michigan, United States
• Minnesota Oncology Hematology, P.A. Minnesota Oncology Hematology — Minneapolis, Minnesota, United States
• Nebraska Cancer Specialists Oncology Hematology West — Omaha, Nebraska, United States
• Arizona Oncology Associates HOPE Division — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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