Status:
COMPLETED
BKM120 for Patients With PI3K-activated Tumors
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
PI3K Pathway Activated Tumors
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
March 29 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2016
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT01833169
Start Date
March 29 2013
End Date
September 26 2016
Last Update
October 19 2018
Active Locations (59)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Oncology Associates HOPE Division
Phoenix, Arizona, United States
2
Arizona Oncology Associates PC- HAL
Sedona, Arizona, United States, 86336
3
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
4
Sarcoma Oncology Center
Santa Monica, California, United States, 90403