Overview

BKM120 for Patients With PI3K-activated Tumors

Status:
Completed

Trial end date:
2016-09-26

Target enrollment:
0

Participant gender:
All

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 warrant further study.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

- 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 Criteria:

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.