Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer
Status: Recruiting
Phase: Phase 2
Diagnosis: Lung Cancer
NCT ID: NCT01297491
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-231
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.
Conducting Institutions:
Massachusetts General Hospital, Brigham and Women's Hospital, Dana-Farber Cancer Institute
Overall PI:
Jeffrey Engelman, MD, PhD,
Massachusetts General Hospital
Site-responsible Investigators:
Bruce Johnson, MD,
Dana-Farber Cancer Institute
Contacts:
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute:
Kelly Masone, 617-632-3383,
kmasone@partners.org
Eligibility 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