Safety and Efficacy of Buparlisib (BKM120) in Patients With Untreated Squamous Non-small Cell Lung Cancer
Overview[ - collapse ][ - ]
Purpose | The Phase Ib part of the study aims to determine the maximum tolerated dose/recommended Phase II dose (MTD/RP2D) of once daily buparlisib in combination with every-three-week carboplatin and paclitaxel in patients with previously untreated metastatic squamous NSCLC. The purpose of the Phase II portion of the study is to assess the treatment effect of adding buparlisib versus buparlisib-matching placebo to every-three-week carboplatin and paclitaxel on progression free survival (PFS) in patients with previously untreated metastatic squamous NSCLC. |
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Condition | Non-Small Cell Lunch Cancer |
Intervention | Drug: BKM120 Drug: placebo Drug: Carboplatin Drug: Paclitaxel |
Phase | Phase 1/Phase 2 |
Sponsor | Novartis Pharmaceuticals |
Responsible Party | Novartis |
ClinicalTrials.gov Identifier | NCT01820325 |
First Received | March 25, 2013 |
Last Updated | February 17, 2014 |
Last verified | February 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | March 25, 2013 |
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Last Updated Date | February 17, 2014 |
Start Date | September 2013 |
Estimated Primary Completion Date | December 2016 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Safety and Efficacy of Buparlisib (BKM120) in Patients With Untreated Squamous Non-small Cell Lung Cancer |
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Official Title | A Dose-finding Phase Ib Study Followed by a Randomized, Double-blind Phase II Study of Carboplatin and Paclitaxel With or Without Buparlisib in Patients With Previously Untreated Metastatic Non-small Cell Lung Cancer (NSCLC) of Squamous Histology |
Brief Summary | The Phase Ib part of the study aims to determine the maximum tolerated dose/recommended Phase II dose (MTD/RP2D) of once daily buparlisib in combination with every-three-week carboplatin and paclitaxel in patients with previously untreated metastatic squamous NSCLC. The purpose of the Phase II portion of the study is to assess the treatment effect of adding buparlisib versus buparlisib-matching placebo to every-three-week carboplatin and paclitaxel on progression free survival (PFS) in patients with previously untreated metastatic squamous NSCLC. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1/Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment |
Condition | Non-Small Cell Lunch Cancer |
Intervention | Drug: BKM120 Drug: placebo Placebo + Carboplatin + Paclitaxel Drug: Carboplatin Drug: Paclitaxel |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 220 |
Estimated Completion Date | December 2016 |
Estimated Primary Completion Date | December 2016 |
Eligibility Criteria | Inclusion Criteria: - Patient has histologically and/or cytologically confirmed diagnosis of squamous NSCLC. Diagnosis of mixed squamous with a squamous component will be acceptable for enrollment. - Patient has archival or new tumor tissue for the analysis of PI3K biomarkers - Tumor is Stage IV at the time of signed informed consent (UICC/AJCC version 7) - Patient has measurable or non-measurable disease according to RECIST v1.1 criteria • For the Phase II portion, the patient must have measurable disease according to RECIST 1.1 criteria - Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 that the investigator believes is stable at the time of screening - Patient has adequate bone marrow and organ function Exclusion Criteria: - Patient has received any prior systemic therapies for metastatic NSCLC. Study treatment in this clinical trial must be the patient's first systemic treatment for metastatic NSCLC. Patients are eligible if they received neo-adjuvant or adjuvant systemic therapy followed by a disease-free interval exceeding 12 months. - Patient has symptomatic CNS metastases • Patients with asymptomatic CNS metastases may participate in this trial. The patient must have completed any prior local treatment for CNS metastases ≥ 28 days prior to the start of study treatment (including radiotherapy and/or surgery, or ≥14 days for stereotactic radiosurgery). - Patient is currently receiving warfarin or other coumadin derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed. - Patient is currently receiving treatment with drugs known to be strong inhibitors or inducers of isoenzyme CYP3A. The patient must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the treatment is initiated. Switching to a different medication prior to randomization is allowed. - Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others) or patients with active severe personality disorders (defined according to DSM- IV) are not eligible. Note: for patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous 6 weeks prior to start of study drug - Patient has ≥ CTCAE grade 3 anxiety - Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL) - Patient who does not apply highly effective contraception during the study and through the duration as defined below after the final dose of study treatment. |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Novartis Pharmaceuticals 1-888-669-6682 |
Location Countries | United States, Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Hungary, Italy, Russian Federation, South Africa, Spain, Taiwan, Turkey, United Kingdom |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01820325 |
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Other Study ID Numbers | CBKM120D2204 |
Has Data Monitoring Committee | Yes |
Information Provided By | Novartis |
Study Sponsor | Novartis Pharmaceuticals |
Collaborators | Not Provided |
Investigators | Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals |
Verification Date | February 2014 |
Locations[ + expand ][ + ]
Highlands Oncology Group SC-1 | Fayetteville, Arkansas, United States, 72703 Contact: Tia Hesington | 479-936-9900 | thesington@hogonc.comPrincipal Investigator: Eric S. Schaefer Recruiting |
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USC Norris Cancer Center LAC USC Medical Center | Los Angeles, California, United States, 90033 Contact: Eduardo Mejia | 323-865-3962 | mejia_e@med.usc.eduPrincipal Investigator: Barbara J. Gitlitz Not yet recruiting |
Rocky Mountain Cancer Centers Rocky Mountain Cancer Centers | Greenwood Village, Colorado, United States Contact: Roxanne Riggs | 303-388-4876 | roxanne.riggs@usoncology.comPrincipal Investigator: Robert M. Jotte Recruiting |
Georgetown University/Lombardi Cancer Center Georgetown Univ. Medical Ctr. | Washington, District of Columbia, United States, 20007 Contact: Rebecca Eberle | 202-687-5791 | ree28@georgetown.eduPrincipal Investigator: Giuseppe Giaccone Not yet recruiting |
H. Lee Moffitt Cancer Center & Research Institute H Lee Moffitt | Tampa, Florida, United States, 33612 Contact: Jeff L. Jorski | 813-745-6895 | jeff.jorski@moffitt.orgPrincipal Investigator: Jhanelle Gray Not yet recruiting |
Rush University Medical Center Rush University | Chicago, Illinois, United States, 60612 Contact: Dawn Paulsen | 312-563-4593 | dawn_paulsen@rush.eduPrincipal Investigator: Mary J Fidler Not yet recruiting |
University of Kansas Cancer Center Medical Pavilion | Kansas City, Kansas, United States, 66160 Contact: Collins Julie | +1 913 588 0545 | jcollins4@kumc.eduPrincipal Investigator: Chao Hui Huang Not yet recruiting |
Reliant Medical Group Reliant Medical Group | Worchester, Massachusetts, United States, 01608 Contact: Sonia Martinath | sonia.martinath@reliantmedicalgroup.orgPrincipal Investigator: Saleem Khanani Recruiting |
Montefiore Medical Center SC BKM120 D2204 / D2205 | Bronx, New York, United States, 10461 Contact: Srkantha Gajavelli | 718-405-8539 | sgajavel@montefiore.orgPrincipal Investigator: Bilal Piperdi Not yet recruiting |
Roswell Park Cancer Institute Rosewell | Buffalo, New York, United States, 14263 Contact: Carol Skelly | 716-845-4886 | carl.skelly@roswellpark.orgPrincipal Investigator: Grace Dy Not yet recruiting |
Sanford Research/USD-Fargo | Fargo, North Dakota, United States, 58122 Withdrawn |
Northwest Cancer Specialists Compass Oncology -BKM | Portland, Oregon, United States, 97210 Contact: Denise M. Hill | 360-449-6522 | denise.hill@usoncology.comPrincipal Investigator: David A. Smith Recruiting |
Medical University of South Carolina MUSC | Charleston, South Carolina, United States, 29425 Withdrawn |
Sanford Research Alick Building | Sioux Falls, South Dakota, United States, 57104 Contact: Tammy A Hein | 605-328-1376 | Tammy.A.Hein@Sanfordhealth.orgPrincipal Investigator: Miroslaw Mazurczak Not yet recruiting |
Tennessee Cancer Specialists Center for Biomedical Research | Knoxville, Tennessee, United States, 37909 Contact: Erica Cox | 865-934-2675 | ecox@biomed-research.comPrincipal Investigator: Russell F DeVore Not yet recruiting |
Sarah Cannon Research Institute BKM120D2204/BKM120D2205 | Nashville, Tennessee, United States, 37203 Contact: Emily Angarole | 615-524-4086 | Emily.angarole@scresearch.netPrincipal Investigator: David R. Spigel Not yet recruiting |
Vanderbilt Ingram Cancer Center SC (CTSR) | Nashville, Tennessee, United States, 37203 Contact: BJ Broome | 615-875-0060 | barbara.j.broome@vanderbilt.eduPrincipal Investigator: Leora Horn Not yet recruiting |
US Oncology Central Monitoring | Dallas, Texas, United States, 75246 Withdrawn |
Texas Oncology, P.A. | Fort Worth, Texas, United States, 76104 Contact: Ron Schoenfeldt | 817-850-2000 | Ron.schoenfeldt@McKesson.comPrincipal Investigator: Stephen L. Richey Recruiting |
University of Texas Health Science Center Univ.TX Memorial Herman Cancer | Houston, Texas, United States, 77030 Contact: Susan Cooper | 832-325-7308 | susan.cooper@uth.tmc.eduPrincipal Investigator: Shan Guo Not yet recruiting |
Institute of Oncology Hematology | Laredo, Texas, United States, 78041 Contact: Noe Garcia | 956-753-7839 | ngarcia@stexresearch.comPrincipal Investigator: Eduardo Miranda Not yet recruiting |
Virginia Oncology Associates BKM120D2205/BKM120D2204 | Norfolk, Virginia, United States, 23502 Contact: Gabrielle Whalen | 757-213-5658 | gabrielle.whalen@usocology.comPrincipal Investigator: Paul Conkling Recruiting |
Novartis Investigative Site | Bahía Blanca, Buenos Aires, Argentina, B8001HXM Not yet recruiting |
Novartis Investigative Site | Mar del Plata, Buenos Aires, Argentina, B7600CTO Not yet recruiting |
Novartis Investigative Site | Rosario, Santa Fe, Argentina, S2000KZE Not yet recruiting |
Novartis Investigative Site | Capital Federal, Argentina, 1417 Withdrawn |
Novartis Investigative Site | Clayton, Victoria, Australia, 3168 Not yet recruiting |
Novartis Investigative Site | Brussel, Belgium, 1090 Not yet recruiting |
Novartis Investigative Site | Liege, Belgium, 4000 Not yet recruiting |
Novartis Investigative Site | Liège, Belgium, 4000 Not yet recruiting |
Novartis Investigative Site | Belo Horizonte, MG, Brazil, 30150-270 Not yet recruiting |
Novartis Investigative Site | Recife, PE, Brazil, 50070-550 Not yet recruiting |
Novartis Investigative Site | Rio de Janiero, RJ, Brazil, 20231-050 Not yet recruiting |
Novartis Investigative Site | Ijuí, RS, Brazil, 98700-000 Not yet recruiting |
Novartis Investigative Site | Porto Alegre, RS, Brazil, 90610-000 Not yet recruiting |
Novartis Investigative Site | Barretos, SP, Brazil, 14784-400 Not yet recruiting |
Novartis Investigative Site | São Paulo, SP, Brazil, 01246-000 Not yet recruiting |
Novartis Investigative Site | Edmonton, Alberta, Canada, T6G 1Z2 Not yet recruiting |
Novartis Investigative Site | Ottawa, Ontario, Canada, KIH 7W9 Withdrawn |
Novartis Investigative Site | Toronto, Ontario, Canada, M5G 1Z6 Recruiting |
Novartis Investigative Site | Brno, Czech Republic, 65653 Not yet recruiting |
Novartis Investigative Site | Prague 8, Czech Republic, 180 00 Not yet recruiting |
Novartis Investigative Site | Creteil, France, 94000 Not yet recruiting |
Novartis Investigative Site | Villejuif Cedex, France, 94805 Not yet recruiting |
Novartis Investigative Site | Freiburg, Germany, 79106 Recruiting |
Novartis Investigative Site | Ulm, Germany, 89081 Recruiting |
Novartis Investigative Site | Budapest, Hungary, 1121 Withdrawn |
Novartis Investigative Site | Gyor, Hungary, 9023 Withdrawn |
Novartis Investigative Site | Nyiregyhaza, Hungary, 4400 Not yet recruiting |
Novartis Investigative Site | Pecs, Hungary, 7624 Withdrawn |
Novartis Investigative Site | Veszprém, Hungary, 8200 Not yet recruiting |
Novartis Investigative Site | Zalaegerszeg-Pózva, Hungary, 8900 Not yet recruiting |
Novartis Investigative Site | Catanzaro, CZ, Italy, 88100 Not yet recruiting |
Novartis Investigative Site | Genova, GE, Italy, 16132 Not yet recruiting |
Novartis Investigative Site | Monza, MB, Italy, 20900 Recruiting |
Novartis Investigative Site | Milano, MI, Italy, 20141 Not yet recruiting |
Novartis Investigative Site | Milano, MI, Italy, 20133 Not yet recruiting |
Novartis Investigative Site | Rozzano, MI, Italy, 20089 Not yet recruiting |
Novartis Investigative Site | Padova, PD, Italy, 35100 Not yet recruiting |
Novartis Investigative Site | Napoli, Italy, 80131 Recruiting |
Novartis Investigative Site | Nizhniy Novgorod, Russia, Russian Federation Not yet recruiting |
Novartis Investigative Site | Chelyabinsk, Russian Federation, 454087 Not yet recruiting |
Novartis Investigative Site | Sankt-Peterburg, Russian Federation, 197022 Not yet recruiting |
Novartis Investigative Site | St. Petersburg, Russian Federation, 197758 Not yet recruiting |
Novartis Investigative Site | Bloemfontein, South Africa, 9300 Not yet recruiting |
Novartis Investigative Site | Pretoria, South Africa, 0027 Not yet recruiting |
Novartis Investigative Site | Pretoria, South Africa, 0002 Not yet recruiting |
Novartis Investigative Site | Barcelona, Cataluña, Spain, 08035 Recruiting |
Novartis Investigative Site | Madrid, Spain, 28046 Recruiting |
Novartis Investigative Site | Kuei-Shan Chiang, Taoyuan/ Taiwan ROC, Taiwan, 33305 Not yet recruiting |
Novartis Investigative Site | Niaosong Township, Taiwan, 83301 Not yet recruiting |
Novartis Investigative Site | Taichung, Taiwan, 40447 Not yet recruiting |
Novartis Investigative Site | Gaziantep, Turkey, 27070 Not yet recruiting |
Novartis Investigative Site | Istanbul, Turkey, 34303 Not yet recruiting |
Novartis Investigative Site | Izmir, Turkey, 35040 Not yet recruiting |
Novartis Investigative Site | Sihhiye/Ankara, Turkey, 06100 Not yet recruiting |
Novartis Investigative Site | Birmingham, United Kingdom, B9 5SS Not yet recruiting |
Novartis Investigative Site | Leicester, United Kingdom, LE1 5WW Not yet recruiting |
Novartis Investigative Site | Wirral, United Kingdom, CH63 3JY Suspended |