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

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BKM120
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring NSCLC, PI3K

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ironwood Cancer and Research Centers SC
  • Arizona Oncology Associates Tucson (Rudasill & La Cholla)
  • Mayo Clinic - Arizona Mayo Scottsdale AZ
  • Highlands Oncology Group Dept of Highlands Oncology Grp
  • Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr.
  • University of California at San Diego, Moores Cancer Ctr SC
  • University of Colorado Univ CO
  • Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer
  • H. Lee Moffitt Cancer Center & Research Institute H Lee Moffitt
  • Emory University School of Medicine/Winship Cancer Institute Emory 2
  • Rush University Medical Center SC
  • University of Chicago Medical Center Unvi Chi
  • University of Kansas Cancer Center Univ of KS
  • Massachusetts General Hospital Mass General
  • Fallon Clinic at Worcester Medical Center Fallon Clinic Worcester Med
  • Karmanos Cancer Institute Wayne St Karmanos
  • Washington University School of Medicine Washington University (16)
  • Hematology Oncology Associates of Northern New Jersey PA DeptofHem-OncofNorthern NJ (2)
  • Overlook Hospital - Carol G Simon Cancer Center Carol G Simon
  • Roswell Park Cancer Institute Rosewell
  • Memorial Sloan Kettering Cancer Center Sloan Kettering
  • Duke University Medical Center Duke 2
  • MetroHealth Medical Center Dept.ofMetroHealthMedCtr.(2)
  • University of Oklahoma Health Sciences Center Dept. of Oklahoma Univ. HSC
  • Northwest Cancer Specialists Compass Oncology -BKM
  • University of Pittsburgh Medical Center SC-2
  • Medical University of South Carolina MUSC
  • Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology
  • Texas Oncology South Texas Oncology
  • U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office
  • Virginia Oncology Associates VOA - Lake Wright (2)
  • University of Wisconsin Univ WIsc 2
  • Novartis Investigative Site
  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Squamous BKM120 100mg qd

Non-Squamous BKM120 100mg qd

Arm Description

Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.

Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) Rate as Per Investigator Local Review Measured Using RECIST 1.1 of Patients at 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.

Secondary Outcome Measures

Overall Survival (OS) Using Kaplan-Meier Estimates
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.
Overall Response Rate (ORR) Based on Investigator Assessment
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.
Disease Control Rate (DCR)
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.
Time to Response (TTR)
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.
Duration of Response (DoR)
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.

Full Information

First Posted
February 11, 2011
Last Updated
March 10, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01297491
Brief Title
Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer
Acronym
BASALT-1
Official Title
An Open Label Two-stage Study of Orally Administered BKM120 in Patients With Metastatic Non-small Cell Lung Cancer With Activated PI3K Pathway
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
NSCLC, PI3K

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Squamous BKM120 100mg qd
Arm Type
Experimental
Arm Description
Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
Arm Title
Non-Squamous BKM120 100mg qd
Arm Type
Experimental
Arm Description
Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
Intervention Type
Drug
Intervention Name(s)
BKM120
Other Intervention Name(s)
Buparlisib
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) Rate as Per Investigator Local Review Measured Using RECIST 1.1 of Patients at Week 12
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Overall Survival (OS) Using Kaplan-Meier Estimates
Description
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.
Time Frame
Every 8 weeks up to 24 months
Title
Overall Response Rate (ORR) Based on Investigator Assessment
Description
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.
Time Frame
Every 6 weeks up to 24 months
Title
Disease Control Rate (DCR)
Description
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.
Time Frame
Every 6 weeks up tp 24 months
Title
Time to Response (TTR)
Description
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.
Time Frame
Every 6 weeks up to 24 months
Title
Duration of Response (DoR)
Description
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.
Time Frame
Every 6 weeks up to 24 months

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
26098748
Citation
Vansteenkiste JF, Canon JL, De Braud F, Grossi F, De Pas T, Gray JE, Su WC, Felip E, Yoshioka H, Gridelli C, Dy GK, Thongprasert S, Reck M, Aimone P, Vidam GA, Roussou P, Wang YA, Di Tomaso E, Soria JC. Safety and Efficacy of Buparlisib (BKM120) in Patients with PI3K Pathway-Activated Non-Small Cell Lung Cancer: Results from the Phase II BASALT-1 Study. J Thorac Oncol. 2015 Sep;10(9):1319-1327. doi: 10.1097/JTO.0000000000000607.
Results Reference
result

Learn more about this trial

Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer

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