Phase 2
N=63
Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer
Non-small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01297491 ↗Enrolled (actual)
63
Serious AEs
49.2%
Results posted
Feb 2016
Primary outcome: Primary: Progression Free Survival (PFS) Rate as Per Investigator Local Review Measured Using RECIST 1.1 of Patients at Week 12 — 23.3; 20.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BKM120 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) Rate as Per Investigator Local Review Measured Using RECIST 1.1 of Patients at Week 12 |
23.3; 20.0 | — |
| SECONDARY Overall Survival (OS) Using Kaplan-Meier Estimates |
7.98; 7.20 | — |
| SECONDARY Overall Response Rate (ORR) Based on Investigator Assessment |
3.3; 3.0 | — |
| SECONDARY Disease Control Rate (DCR) |
46.7; 45.5 | — |
| SECONDARY Time to Response (TTR) |
41; 42 | — |
| SECONDARY Duration of Response (DoR) |
73; 85 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01297491). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.