Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer (BASALT-1)

Novartis

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: BKM120

Study type: Interventional

Funder types: Industry

Identifiers

NCT01297491

CBKM120D2201

2010-024011-14 (EudraCT Number)

Details and patient eligibility

About

The purpose of this two-stage phase II study is to assess the efficacy of BKM120, as measured by determining the progression free survival (PFS), in patients with pretreated metastatic Non-small Cell Lung Cancer (NSCLC) that exhibits PI3K pathway activation. BKM120 will be investigated in two groups of NSCLC patients according to the histology of the cancer: squamous and non-squamous.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed NSCLC with activated PI3K pathway
• Progressive disease after prior systemic antineoplastic treatment(s) for advanced NSCLC
• Archival or fresh tumor biopsy must be available for profiling
• Measurable and/or non-measurable disease as per RECIST 1.1 criteria
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Adequate organ function as assessed by laboratory tests

Exclusion criteria

• Patient has received previous treatment with PI3K inhibitors
• Patient with squamous NSCLC has received more than one line of chemotherapy treatment for metastatic disease; patient with non-squamous NSCLC has received more than two lines of systemic antineoplastic treatment for metastatic disease
• Uncontrolled or symptomatic CNS metastases
• Concurrent use of any other approved or investigational antineoplastic agent
• Radiotherapy ≤ 28 days prior to starting study drug
• Major surgery within 28 days prior to starting study drug
• History of clinically significant cardiac dysfunction, mood disorders, or poorly controlled diabetes mellitus
• Current treatment with medication that has a known risk to prolong the QT interval or inducing Torsades de Pointes
• Impairment of gastrointestinal (GI) function
• Chronic treatment with steroids or another immunosuppressive agent.
• Concurrent severe and/or uncontrolled medical condition
• Currently receiving Warfarin or another coumarin derivative
• Known history of HIV infection
• Sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of causality)
• Pregnancy, lactation, or breastfeeding
• Woman of child-bearing potential

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

Squamous BKM120 100mg qd

Experimental group

Description:

Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.

Treatment:

Drug: BKM120

Non-Squamous BKM120 100mg qd

Experimental group

Description:

Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.

Treatment:

Drug: BKM120