BKM120 for Patients With PI3K-activated Tumors (SIGNATURE)

Novartis

Status and phase: Completed; Phase 2

Conditions: PI3K Pathway Activated Tumors

Treatments: Drug: BKM120

Study type: Interventional

Funder types: Industry

Identifiers

NCT01833169

CBKM120ZUS40

Details and patient eligibility

About

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.

Enrollment: 146 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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146 participants in 1 patient group

BKM120

Experimental group

Description:

BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle

Treatment:

Drug: BKM120