Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer (BASALT-1)

March 10, 2016 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1050AAK
        • Novartis Investigative Site
      • Cordoba, Argentina, X5002AOQ
        • Novartis Investigative Site
    • Viedma
      • Rio Negro, Viedma, Argentina, 8500
        • Novartis Investigative Site
  • Belgium
      • Brussel, Belgium, 1090
        • Novartis Investigative Site
      • Charleroi, Belgium, 6000
        • Novartis Investigative Site
      • Genk, Belgium, 3600
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
      • Libramont, Belgium, 6800
        • Novartis Investigative Site
  • Brazil
    • BA
      • Salvador, BA, Brazil, 41253-190
        • Novartis Investigative Site
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20230-130
        • Novartis Investigative Site
    • SC
      • Florianopolis, SC, Brazil, 88034-000
        • Novartis Investigative Site
    • SP
      • Barretos, SP, Brazil, 14784-400
        • Novartis Investigative Site
      • São Paulo, SP, Brazil, 01246-000
        • Novartis Investigative Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Novartis Investigative Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 1Z5
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H2X 3J4
        • Novartis Investigative Site
  • France
      • Caen Cedex, France, 14021
        • Novartis Investigative Site
      • Creteil, France, 94000
        • Novartis Investigative Site
      • Marseille cedex 20, France, 13915
        • Novartis Investigative Site
      • Rennes, France, F-35043
        • Novartis Investigative Site
      • Villejuif Cedex, France, 94805
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 13125
        • Novartis Investigative Site
      • Essen, Germany, 45147
        • Novartis Investigative Site
      • Gauting, Germany, 82131
        • Novartis Investigative Site
      • Grosshansdorf, Germany, 22927
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Novartis Investigative Site
      • Koeln, Germany, 51109
        • Novartis Investigative Site
      • Nuernberg, Germany, 90419
        • Novartis Investigative Site
      • Oldenburg, Germany, 26121
        • Novartis Investigative Site
      • Recklinghausen, Germany, 45657
        • Novartis Investigative Site
  • Hong Kong
      • Hongkong, Hong Kong
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1125
        • Novartis Investigative Site
      • Budapest, Hungary, 1121
        • Novartis Investigative Site
      • Deszk, Hungary, 6772
        • Novartis Investigative Site
      • Mátraháza, Hungary, 3233
        • Novartis Investigative Site
      • Szolnok, Hungary, H-5000
        • Novartis Investigative Site
  • Italy
    • AV
      • Avellino, AV, Italy, 83100
        • Novartis Investigative Site
    • GE
      • Genova, GE, Italy, 16132
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italy, 20133
        • Novartis Investigative Site
      • Milano, MI, Italy, 20141
        • Novartis Investigative Site
    • PR
      • Parma, PR, Italy, 43100
        • Novartis Investigative Site
    • UD
      • Udine, UD, Italy, 33100
        • Novartis Investigative Site
  • Japan
    • Okayama
      • Kurashiki, Okayama, Japan, 710-8602
        • Novartis Investigative Site
    • Tokyo
      • Koto, Tokyo, Japan, 135-8550
        • Novartis Investigative Site
  • Netherlands
      • Maastricht, Netherlands, 6229 HX
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 169610
        • Novartis Investigative Site
  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Novartis Investigative Site
    • Cataluña
      • Mataro, Cataluña, Spain, 08301
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, Spain, 03010
        • Novartis Investigative Site
  • Taiwan
    • Taiwan ROC
      • Tainan 704, Taiwan ROC, Taiwan, 704
        • Novartis Investigative Site
      • Taipei, Taiwan ROC, Taiwan, 100
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10700
        • Novartis Investigative Site
      • Chiang Mai, Thailand, 50200
        • Novartis Investigative Site
  • Turkey
      • Altunizade, Turkey, 34662
        • Novartis Investigative Site
      • Izmir, Turkey, 35040
        • Novartis Investigative Site
  • United Kingdom
      • Leicester, United Kingdom, LE1 5WW
        • Novartis Investigative Site
      • London, United Kingdom, SE1 9RT
        • Novartis Investigative Site
      • Manchester, United Kingdom, M20 4BX
        • Novartis Investigative Site
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • Novartis Investigative Site
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Ironwood Cancer and Research Centers SC
      • Phoenix, Arizona, United States
        • Arizona Oncology Associates Tucson (Rudasill & La Cholla)
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic - Arizona Mayo Scottsdale AZ
    • Arkansas
      • Fayetteville, Arkansas, United States, 72753
        • Highlands Oncology Group Dept of Highlands Oncology Grp
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr.
      • San Diego, California, United States, 92103
        • University of California at San Diego, Moores Cancer Ctr SC
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Univ CO
      • Greenwood Village, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center & Research Institute H Lee Moffitt
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine/Winship Cancer Institute Emory 2
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center SC
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center Unvi Chi
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Cancer Center Univ of KS
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Mass General
      • Worcester, Massachusetts, United States, 01608
        • Fallon Clinic at Worcester Medical Center Fallon Clinic Worcester Med
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute Wayne St Karmanos
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine Washington University (16)
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Hematology Oncology Associates of Northern New Jersey PA DeptofHem-OncofNorthern NJ (2)
      • Summit, New Jersey, United States, 07901
        • Overlook Hospital - Carol G Simon Cancer Center Carol G Simon
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute Rosewell
      • NY, New York, United States, 90033
        • Memorial Sloan Kettering Cancer Center Sloan Kettering
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center Duke 2
    • Ohio
      • Cleveland, Ohio, United States, 44109-1998
        • MetroHealth Medical Center Dept.ofMetroHealthMedCtr.(2)
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center Dept. of Oklahoma Univ. HSC
    • Oregon
      • Portland, Oregon, United States, 97210
        • Northwest Cancer Specialists Compass Oncology -BKM
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center SC-2
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina MUSC
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology
      • Dallas, Texas, United States, 75251
        • Texas Oncology South Texas Oncology
      • Dallas, Texas, United States, 75390-9151
        • U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office
    • Virginia
      • *see Various Departments*, Virginia, United States, 23502
        • Virginia Oncology Associates VOA - Lake Wright (2)
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Univ Wisc 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Squamous BKM120 100mg qd
Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
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.
Other Names:
  • Buparlisib
Experimental: Non-Squamous BKM120 100mg qd
Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
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.
Other Names:
  • Buparlisib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS) Rate as Per Investigator Local Review Measured Using RECIST 1.1 of Patients at Week 12
Time Frame: Week 12

PFS rate was defined as the percentage of participants who were progression free at 12 weeks. Participants were considered as a "success" for PFS rate evaluated at 12 weeks if they presented an overall response at their 2nd post-baseline tumor assessment.The enrollment into the study in either histology group would stop for futility if a PFS rate <50% at 12 weeks was observed.

No statistical analysis was planned for this primary outcome. The results of the primary objective was based on the data from the interim analysis that took place at the cut off dates: 10-Apr-2013 for non-squamous and 08-Jan-2014 for squamous group.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) Using Kaplan-Meier Estimates
Time Frame: Every 8 weeks up to 24 months
OS was defined as the time from start of study drug (Stage 1) until death from any cause. If a patient was not known to have died, survival was censored at the date of last contact.
Every 8 weeks up to 24 months
Overall Response Rate (ORR) Based on Investigator Assessment
Time Frame: Every 6 weeks up to 24 months
ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR). Complete response was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. Partial response was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Analyses of response rates were performed based on investigators' assessments (as per RECIST 1.1 criteria). ORR included all patients with and without measurable disease at baseline.
Every 6 weeks up to 24 months
Disease Control Rate (DCR)
Time Frame: Every 6 weeks up tp 24 months

DCR defined as the percentage of participants with best overall response of CR or PR or stable disease (SD). Complete response was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. Partial response was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD.

Analyses of response rates were performed based on investigators' assessments (as per RECIST 1.1 criteria). DCR included all participants with and without measurable disease at baseline.
Every 6 weeks up tp 24 months
Time to Response (TTR)
Time Frame: Every 6 weeks up to 24 months
TTR for a participant was defined as the time from the first treatment date to the date of first documented confirmed CR or PR evaluation. The date of event was defined as the date of response that was first determined and not using the date the response was confirmed.
Every 6 weeks up to 24 months
Duration of Response (DoR)
Time Frame: Every 6 weeks up to 24 months
DoR was defined as the elapsed time between the date of first documented CR or PR response (not the date of confirmed response) and the following date of event defined as the first documented progression or death due to underlying cancer.
Every 6 weeks up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

February 11, 2011

First Submitted That Met QC Criteria

February 15, 2011

First Posted (Estimate)

February 16, 2011

Study Record Updates

Last Update Posted (Estimate)

March 11, 2016

Last Update Submitted That Met QC Criteria

March 10, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBKM120D2201
  • 2010-024011-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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