Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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