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BKM120 in PI3K-activated tumors (SIGNATURE Module 1)
NCT01833169Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2013
- Primary completion
- Sep 2016
- Countries
- 1
- Sponsor
- Novartis
- Modality
- Small Molecules
- Drugs
- buparlisib
- Conditions
- solid tumorhematologic malignancy
01
Overview
Phase 2, open-label, single-arm trial of buparlisib in solid tumor and hematologic malignancy, sponsored by Novartis. Primary endpoint: Clinical Benefit Response Rate at Week 16. Started Mar 2013; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
BKM120
BKM120 100 mg daily
03
Who it enrols
Patients with PI3K pathway-activated solid tumors or hematologic malignancies (excluding endometrial, glioblastoma, NSCLC, prostate, or breast cancer) who have progressed on at least one prior therapy.
04
Endpoints
Primary
Clinical Benefit Response Rate
Secondary
Overall Response of Partial Response (PR) or Greater
Progression-Free Survival
Overall Survival
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