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Non-small Cell Lung CancerPhase 2BASALT-1NCT01297491

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

A Phase 2 study testing BKM120 in people with Non-small Cell Lung Cancer, run by Novartis Pharmaceuticals at 92 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
BKM120
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
92 sitesin 18 countries
Study dates
May 2011to Oct 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

92 sites in 18 countries.

92 sites in 18 countries

United States32 sites

  • Virginia Oncology Associates VOA - Lake Wright (2)

    *see Various Departments*, Virginia, 23502

  • Emory University School of Medicine/Winship Cancer Institute Emory 2

    Atlanta, Georgia, 30322

  • University of Colorado Univ CO

    Aurora, Colorado, 80045

  • Massachusetts General Hospital Mass General

    Boston, Massachusetts, 02114

  • Roswell Park Cancer Institute Rosewell

    Buffalo, New York, 14263

  • Ironwood Cancer and Research Centers SC

    Chandler, Arizona, 85224

  • Medical University of South Carolina MUSC

    Charleston, South Carolina, 29425

  • Rush University Medical Center SC

    Chicago, Illinois, 60612

  • University of Chicago Medical Center Unvi Chi

    Chicago, Illinois, 60637

  • MetroHealth Medical Center Dept.ofMetroHealthMedCtr.(2)

    Cleveland, Ohio, 44109-1998

  • Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology

    Dallas, Texas, 75246

  • Texas Oncology South Texas Oncology

    Dallas, Texas, 75251

  • U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office

    Dallas, Texas, 75390-9151

  • Karmanos Cancer Institute Wayne St Karmanos

    Detroit, Michigan, 48201

  • Duke University Medical Center Duke 2

    Durham, North Carolina, 27710

  • Highlands Oncology Group Dept of Highlands Oncology Grp

    Fayetteville, Arkansas, 72753

  • Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer

    Greenwood Village, Colorado, 80218

  • University of Kansas Cancer Center Univ of KS

    Kansas City, Kansas, 66160

  • Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr.

    Los Angeles, California, 90048

  • University of Wisconsin Univ WIsc 2

    Madison, Wisconsin, 53792

  • Hematology Oncology Associates of Northern New Jersey PA DeptofHem-OncofNorthern NJ (2)

    Morristown, New Jersey, 07962

  • Memorial Sloan Kettering Cancer Center Sloan Kettering

    New York, New York, 90033

  • University of Oklahoma Health Sciences Center Dept. of Oklahoma Univ. HSC

    Oklahoma City, Oklahoma, 73104

  • Arizona Oncology Associates Tucson (Rudasill & La Cholla)

    Phoenix, Arizona

  • University of Pittsburgh Medical Center SC-2

    Pittsburgh, Pennsylvania, 15213

  • Northwest Cancer Specialists Compass Oncology -BKM

    Portland, Oregon, 97210

  • University of California at San Diego, Moores Cancer Ctr SC

    San Diego, California, 92103

  • Mayo Clinic - Arizona Mayo Scottsdale AZ

    Scottsdale, Arizona, 85259

  • Washington University School of Medicine Washington University (16)

    St Louis, Missouri, 63110

  • Overlook Hospital - Carol G Simon Cancer Center Carol G Simon

    Summit, New Jersey, 07901

  • H. Lee Moffitt Cancer Center & Research Institute H Lee Moffitt

    Tampa, Florida, 33612

  • Fallon Clinic at Worcester Medical Center Fallon Clinic Worcester Med

    Worcester, Massachusetts, 01608

Other trials in United States

Germany9 sites

  • Novartis Investigative Site

    Berlin, 13125

  • Novartis Investigative Site

    Cologne, 51109

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Gauting, 82131

  • Novartis Investigative Site

    Großhansdorf, 22927

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Nuremberg, 90419

  • Novartis Investigative Site

    Oldenburg, 26121

  • Novartis Investigative Site

    Recklinghausen, 45657

Other trials in Germany

Italy6 sites

  • Novartis Investigative Site

    Avellino, AV, 83100

  • Novartis Investigative Site

    Genova, GE, 16132

  • Novartis Investigative Site

    Milan, MI, 20133

  • Novartis Investigative Site

    Milan, MI, 20141

  • Novartis Investigative Site

    Parma, PR, 43100

  • Novartis Investigative Site

    Udine, UD, 33100

Other trials in Italy

Belgium5 sites

  • Novartis Investigative Site

    Brussels, 1090

  • Novartis Investigative Site

    Charleroi, 6000

  • Novartis Investigative Site

    Genk, 3600

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Libramont, 6800

Other trials in Belgium

Brazil5 sites

  • Novartis Investigative Site

    Barretos, São Paulo, 14784-400

  • Novartis Investigative Site

    Florianópolis, Santa Catarina, 88034-000

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 20230-130

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 41253-190

  • Novartis Investigative Site

    São Paulo, São Paulo, 01246-000

Other trials in Brazil

France5 sites

  • Novartis Investigative Site

    Caen, 14021

  • Novartis Investigative Site

    Créteil, 94000

  • Novartis Investigative Site

    Marseille, 13915

  • Novartis Investigative Site

    Rennes, F-35043

  • Novartis Investigative Site

    Villejuif, 94805

Other trials in France

Hungary5 sites

  • Novartis Investigative Site

    Budapest, 1121

  • Novartis Investigative Site

    Budapest, 1125

  • Novartis Investigative Site

    Deszk, 6772

  • Novartis Investigative Site

    Mátraháza, 3233

  • Novartis Investigative Site

    Szolnok, H-5000

Other trials in Hungary

Spain4 sites

  • Novartis Investigative Site

    Alicante, Valencia, 03010

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035

  • Novartis Investigative Site

    Mataró, Catalonia, 08301

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208

Other trials in Spain

United Kingdom4 sites

  • Novartis Investigative Site

    Leicester, LE1 5WW

  • Novartis Investigative Site

    London, SE1 9RT

  • Novartis Investigative Site

    Manchester, M20 4BX

  • Novartis Investigative Site

    Northwood, Middlesex, HA6 2RN

Other trials in United Kingdom

Argentina3 sites

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1050AAK

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5002AOQ

  • Novartis Investigative Site

    Rio Negro, Viedma, 8500

Other trials in Argentina

Canada3 sites

  • Novartis Investigative Site

    Montreal, Quebec, H2X 3J4

  • Novartis Investigative Site

    Toronto, Ontario, M5G 1Z5

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Japan2 sites

  • Novartis Investigative Site

    Koto, Tokyo, 135-8550

  • Novartis Investigative Site

    Kurashiki, Okayama-ken, 710-8602

Other trials in Japan

Taiwan2 sites

  • Novartis Investigative Site

    Tainan, Taiwan ROC, 704

  • Novartis Investigative Site

    Taipei, Taiwan ROC, 100

Other trials in Taiwan

Thailand2 sites

  • Novartis Investigative Site

    Bangkok, 10700

  • Novartis Investigative Site

    Chiang Mai, 50200

Other trials in Thailand

Turkey (Türkiye)2 sites

  • Novartis Investigative Site

    Altunizade, 34662

  • Novartis Investigative Site

    Izmir, Turkey, 35040

Other trials in Turkey (Türkiye)

Hong Kong1 site

  • Novartis Investigative Site

    Hong Kong

Other trials in Hong Kong

Netherlands1 site

  • Novartis Investigative Site

    Maastricht, 6229 HX

Other trials in Netherlands

Singapore1 site

  • Novartis Investigative Site

    Singapore, Singapore, 169610

Other trials in Singapore

About this study

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

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.

Being tested
BKM120
Keywords
NSCLC, PI3K
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BKM120Drug

    Also called Buparlisib

    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.

Study groups in NCT01297491
Study groupRoleWhat they receive
Squamous BKM120 100mg qdExperimentalDiagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
Receives: Drug: BKM120
Non-Squamous BKM120 100mg qdExperimentalDiagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
Receives: Drug: BKM120

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 12

Secondary outcomes (5)

  1. 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.

    Measured: Every 8 weeks up to 24 months

  2. 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.

    Measured: Every 6 weeks up to 24 months

  3. 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.

    Measured: Every 6 weeks up tp 24 months

  4. 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.

    Measured: Every 6 weeks up to 24 months

  5. 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.

    Measured: Every 6 weeks up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01297491
Sponsor's protocol ID
CBKM120D2201
Other IDs
2010-024011-14
Acronym
BASALT-1
Status last verified
Mar 2016
First submitted
11 Feb 2011
Last updated
11 Mar 2016
Data monitoring committee
No

Publications

  • 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.

    PubMed 26098748

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BKM120 in people with Non-small Cell Lung Cancer, run by Novartis Pharmaceuticals at 92 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States, Germany, Italy, Belgium, Brazil and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) Rate as Per Investigator Local Review Measured Using RECIST 1.1 of Patients at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01297491, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2016.

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