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An Open Label Two-stage Study of Orally Administered BKM120 in Patients With Metastatic Non-small Cell Lung Cancer With Activated PI3K Pathway

Phase 2
18 Years
Open (Enrolling)
Non-small Cell Lung Cancer

Thank you

Trial Information

An Open Label Two-stage Study of Orally Administered BKM120 in Patients With Metastatic Non-small Cell Lung Cancer With Activated PI3K Pathway

Inclusion Criteria:

- Histologically confirmed NSCLC with activated PI3K pathway

- Progressive disease after prior systemic antineoplastic treatment(s) for advanced

- 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

- Pregnancy, lactation, or breastfeeding

- Woman of child-bearing potential

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS) as measured using RECIST 1.1

Outcome Time Frame:

Every 6 weeks

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

May 2011

Completion Date:

February 2015

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC,
  • PI3K
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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