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

NCT01297491 | Completed Phase 2 Results

• 2 other identifiers: CBKM120D22012010-024011-14
• Study Type: interventional
• Target: 63
• Locations: 18 countries
• Sites: 92

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.

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC; PI3K

Outcome Measures

Primary Outcomes (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.

  Week 12

Secondary Outcomes (5)

• Overall Survival (OS) Using Kaplan-Meier Estimates

  Every 8 weeks up to 24 months

• Overall Response Rate (ORR) Based on Investigator Assessment

  Every 6 weeks up to 24 months

• Disease Control Rate (DCR)

  Every 6 weeks up tp 24 months

• Time to Response (TTR)

  Every 6 weeks up to 24 months

• Duration of Response (DoR)

  Every 6 weeks up to 24 months

Study Arms (2)

Squamous BKM120 100mg qd

EXPERIMENTAL

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

Drug: BKM120

Non-Squamous BKM120 100mg qd

EXPERIMENTAL

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

Drug: BKM120

Interventions

BKM120 DRUG

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.

Also known as: Buparlisib

Non-Squamous BKM120 100mg qd; Squamous BKM120 100mg qd

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (92)

Ironwood Cancer and Research Centers SC

Chandler, Arizona, 85224, United States

Location

Arizona Oncology Associates Tucson (Rudasill & La Cholla)

Phoenix, Arizona, United States

Location

Mayo Clinic - Arizona Mayo Scottsdale AZ

Scottsdale, Arizona, 85259, United States

Location

Highlands Oncology Group Dept of Highlands Oncology Grp

Fayetteville, Arkansas, 72753, United States

Location

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

Los Angeles, California, 90048, United States

Location

University of California at San Diego, Moores Cancer Ctr SC

San Diego, California, 92103, United States

Location

University of Colorado Univ CO

Aurora, Colorado, 80045, United States

Location

Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer

Greenwood Village, Colorado, 80218, United States

Location

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

Tampa, Florida, 33612, United States

Location

Emory University School of Medicine/Winship Cancer Institute Emory 2

Atlanta, Georgia, 30322, United States

Location

Rush University Medical Center SC

Chicago, Illinois, 60612, United States

Location

University of Chicago Medical Center Unvi Chi

Chicago, Illinois, 60637, United States

Location

University of Kansas Cancer Center Univ of KS

Kansas City, Kansas, 66160, United States

Location

Massachusetts General Hospital Mass General

Boston, Massachusetts, 02114, United States

Location

Fallon Clinic at Worcester Medical Center Fallon Clinic Worcester Med

Worcester, Massachusetts, 01608, United States

Location

Karmanos Cancer Institute Wayne St Karmanos

Detroit, Michigan, 48201, United States

Location

Washington University School of Medicine Washington University (16)

St Louis, Missouri, 63110, United States

Location

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

Morristown, New Jersey, 07962, United States

Location

Overlook Hospital - Carol G Simon Cancer Center Carol G Simon

Summit, New Jersey, 07901, United States

Location

Roswell Park Cancer Institute Rosewell

Buffalo, New York, 14263, United States

Location

Memorial Sloan Kettering Cancer Center Sloan Kettering

New York, New York, 90033, United States

Location

Duke University Medical Center Duke 2

Durham, North Carolina, 27710, United States

Location

MetroHealth Medical Center Dept.ofMetroHealthMedCtr.(2)

Cleveland, Ohio, 44109-1998, United States

Location

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

Oklahoma City, Oklahoma, 73104, United States

Location

Northwest Cancer Specialists Compass Oncology -BKM

Portland, Oregon, 97210, United States

Location

University of Pittsburgh Medical Center SC-2

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina MUSC

Charleston, South Carolina, 29425, United States

Location

Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology

Dallas, Texas, 75246, United States

Location

Texas Oncology South Texas Oncology

Dallas, Texas, 75251, United States

Location

U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office

Dallas, Texas, 75390-9151, United States

Location

Virginia Oncology Associates VOA - Lake Wright (2)

*see Various Departments*, Virginia, 23502, United States

Location

University of Wisconsin Univ WIsc 2

Madison, Wisconsin, 53792, United States

Location

Novartis Investigative Site

Buenos Aires, Buenos Aires, C1050AAK, Argentina

Location

Novartis Investigative Site

Córdoba, Córdoba Province, X5002AOQ, Argentina

Location

Novartis Investigative Site

Rio Negro, Viedma, 8500, Argentina

Location

Novartis Investigative Site

Brussels, 1090, Belgium

Location

Novartis Investigative Site

Charleroi, 6000, Belgium

Location

Novartis Investigative Site

Genk, 3600, Belgium

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Libramont, 6800, Belgium

Location

Novartis Investigative Site

Salvador, Estado de Bahia, 41253-190, Brazil

Location

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, 20230-130, Brazil

Location

Novartis Investigative Site

Florianópolis, Santa Catarina, 88034-000, Brazil

Location

Novartis Investigative Site

Barretos, São Paulo, 14784-400, Brazil

Location

Novartis Investigative Site

São Paulo, São Paulo, 01246-000, Brazil

Location

Novartis Investigative Site

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Novartis Investigative Site

Toronto, Ontario, M5G 1Z5, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H2X 3J4, Canada

Location

Novartis Investigative Site

Caen, 14021, France

Location

Novartis Investigative Site

Créteil, 94000, France

Location

Novartis Investigative Site

Marseille, 13915, France

Location

Novartis Investigative Site

Rennes, F-35043, France

Location

Novartis Investigative Site

Villejuif, 94805, France

Location

Novartis Investigative Site

Berlin, 13125, Germany

Location

Novartis Investigative Site

Cologne, 51109, Germany

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Gauting, 82131, Germany

Location

Novartis Investigative Site

Großhansdorf, 22927, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

Nuremberg, 90419, Germany

Location

Novartis Investigative Site

Oldenburg, 26121, Germany

Location

Novartis Investigative Site

Recklinghausen, 45657, Germany

Location

Novartis Investigative Site

Hong Kong, Hong Kong

Location

Novartis Investigative Site

Budapest, 1121, Hungary

Location

Novartis Investigative Site

Budapest, 1125, Hungary

Location

Novartis Investigative Site

Deszk, 6772, Hungary

Location

Novartis Investigative Site

Mátraháza, 3233, Hungary

Location

Novartis Investigative Site

Szolnok, H-5000, Hungary

Location

Novartis Investigative Site

Avellino, AV, 83100, Italy

Location

Novartis Investigative Site

Genova, GE, 16132, Italy

Location

Novartis Investigative Site

Milan, MI, 20133, Italy

Location

Novartis Investigative Site

Milan, MI, 20141, Italy

Location

Novartis Investigative Site

Parma, PR, 43100, Italy

Location

Novartis Investigative Site

Udine, UD, 33100, Italy

Location

Novartis Investigative Site

Kurashiki, Okayama-ken, 710-8602, Japan

Location

Novartis Investigative Site

Koto, Tokyo, 135-8550, Japan

Location

Novartis Investigative Site

Maastricht, 6229 HX, Netherlands

Location

Novartis Investigative Site

Singapore, Singapore, 169610, Singapore

Location

Novartis Investigative Site

Sabadell, Barcelona, 08208, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Mataró, Catalonia, 08301, Spain

Location

Novartis Investigative Site

Alicante, Valencia, 03010, Spain

Location

Novartis Investigative Site

Tainan, Taiwan ROC, 704, Taiwan

Location

Novartis Investigative Site

Taipei, Taiwan ROC, 100, Taiwan

Location

Novartis Investigative Site

Bangkok, 10700, Thailand

Location

Novartis Investigative Site

Chiang Mai, 50200, Thailand

Location

Novartis Investigative Site

Izmir, Turkey, 35040, Turkey (Türkiye)

Location

Novartis Investigative Site

Altunizade, 34662, Turkey (Türkiye)

Location

Novartis Investigative Site

Northwood, Middlesex, HA6 2RN, United Kingdom

Location

Novartis Investigative Site

Leicester, LE1 5WW, United Kingdom

Location

Novartis Investigative Site

London, SE1 9RT, United Kingdom

Location

Novartis Investigative Site

Manchester, M20 4BX, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 26098748 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

NVP-BKM120

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

trialandresults.registries@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2011
• First Posted: February 16, 2011
• Study Start: May 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 11, 2016
• Results First Posted: February 2, 2016

Record last verified: 2016-03

Locations

CA (3); BE (5); ES (4); DE (9); US (32); JP (2); NL (1); AR (3); TW (2); GB (4); IT (6); BR (5); HK (1); TU (2); TH (2); FR (5); HU (5); SG (1)