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

CompletadoFase 2ClinicalTrials.gov

ID: NCT01297491Tipo: INTERVENTIONALInicio: 1 de may de 2011Fin estimado: 1 de oct de 2014

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

BKM120

Buparlisib was supplied as 10mg or 50mg capsules. It was administered on a continuous once daily dosing schedule at a dose of 100 mg. The patient was dosed on a flat scale of mg/day and not adjusted to body weight or body surface area.

Ubicaciones

Novartis Investigative Site

Buenos Aires, Buenos Aires, Argentina

Novartis Investigative Site

Córdoba, Córdoba Province, Argentina

Novartis Investigative Site

Rio Negro, Viedma, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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