Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Phase II, Double-Blind, Placebo-Controlled, Randomized Study Evaluating the Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab With and Without GDC-0941 in Patients With Previously Untreated Advanced or Recurrent Non-small Cell Lung Cancer
Verified date | April 2017 |
Source | Genentech, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This multicenter, randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of carboplatin/paclitaxel and carboplatin/paclitaxel/bevacizumab with and without pictilisib in particpants with previously untreated advanced or recurrent non-small cell lung cancer (NSCLC). Particpants will be randomized to receive 4 cycles of carboplatin (C)/paclitaxel (P) and either pictilisib or placebo, with (participants with non-squamous NSCLC) or without (participants with squamous NSCLC) bevacizumab (B). Anticipated time on study treatment is until disease progression or intolerable toxicity occurs. Participants in placebo arms with disease progression may cross over to open-label active pictilisib.
Status | Completed |
Enrollment | 501 |
Est. completion date | March 30, 2016 |
Est. primary completion date | March 30, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically documented advanced (Stage IV) or recurrent squamous (Arms A and B) or non-squamous (Arms C, D, E, and F) non-small cell lung cancer (NSCLC) - Consent to the collection of an archival formalin-fixed paraffin-embedded (FFPE) block or freshly cut unstained tumor slides from archival tumor tissue or a newly collected tumor sample - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Disease that is measurable per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 - Adequate hematologic and end organ function - Use of two effective forms of contraception Exclusion Criteria: - NSCLC with documented epidermal growth factor receptor (EGFR) mutation associated with response to EGFR inhibitors or documented fusion gene involving anaplastic lymphoma kinase (ALK) gene - Prior therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors, radiotherapy, immunotherapy, hormonal therapy, or investigational therapy) before Day 1 of Cycle 1 for the treatment of advanced (Stage IV) or recurrent NSCLC - Known central nervous system (CNS) disease except for treated brain metastases - Type I diabetes - Type II diabetes requiring chronic therapy with insulin - Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk for treatment complications - Medical conditions that would contraindicate bevacizumab therapy in non-squamous NSCLC (Arms C, D, E, and F) |
Country | Name | City | State |
---|---|---|---|
Argentina | Clinica Universitaria Reina Fabiola | Cordoba | |
Argentina | Instituto FIDES | La Plata | |
Argentina | Isis Centro Especializado de Luces; Oncology | Santa Fe | |
Australia | Flinders Medical Centre; Medical Oncology | Bedford Park | South Australia |
Australia | Royal Prince Alfred Hospital; Sydney Cancer Centre | Camperdown | New South Wales |
Australia | St Vincent'S Hospital | Darlinghurst | New South Wales |
Australia | Footscray Hospital | Footscray | Victoria |
Australia | Royal Hobart Hospital; Medical Oncology | Hobart | Tasmania |
Australia | Royal Melbourne Hospital; Hematology and Medical Oncology | Parkville | Victoria |
Australia | Calvary Mater Newcastle; Medical Oncology | Waratah | New South Wales |
Brazil | Clinica de Tratamento e Pesquisa Oncologica - Oncotek | Brasilia | DF |
Brazil | Centro de Pesquisas Oncologicas - CEPON | Florianopolis | SC |
Brazil | Hospital Amaral Carvalho | Jau | SP |
Brazil | Liga Norte Riograndense Contra O Câncer | Natal | RN |
Brazil | Hospital Mae de Deus | Porto Alegre | RS |
Brazil | Santa Casa de Misericordia de Porto Alegre | Porto Alegre | RS |
Brazil | Instituto Nacional de Cancer - INCa; Oncologia | Rio de Janeiro | RJ |
Brazil | Centro de Oncologia da Bahia - CENOB | Salvador | BA |
Brazil | Instituto do Cancer do Estado de Sao Paulo - ICESP | Sao Paulo | SP |
Brazil | Instituto de Oncologia de Sorocaba - CEPOS | Sorocaba | SP |
Canada | Hopital du Sacre-Coeur | Montreal | Quebec |
Canada | Mcgill University - Royal Victoria Hospital; Oncology | Montreal | Quebec |
Chile | Clinica Santa Maria | Santiago | |
Chile | Fundacion Arturo Lopez Perez | Santiago | |
Chile | Instituto Oncologico del sur | Temuco | |
Chile | Hospital Clinico Vina del Mar | Viña del Mar | |
France | Hopital Morvan | Brest | |
France | Clinique Victor Hugo; Radiotherapie | Le Mans | |
France | Clinique Catherine de Sienne; Service de cancérologie | Nantes | |
France | Ico Rene Gauducheau; Oncologie | Saint Herblain | |
France | Centre Hospitalier de Villefranche sur Saone | Villefranche-sur-Saone | |
France | Institut Gustave Roussy; Departement Oncologie Medicale | Villejuif | |
Germany | Zentralklinik Bad Berka GmbH; Abteilung Onkologie und Hämatologie | Bad Berka | |
Germany | Asklepios-Fachkliniken Muenchen-Gauting; Onkologie | Gauting | |
Germany | Krankenhaus Grosshansdorf;Pneumologie & Thoraxchirurgie | Grosshansdorf | |
Germany | St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie | Karlsruhe | |
Germany | Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie | Mainz | |
Germany | Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie | Regensburg | |
Germany | Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo. | Ulm | |
Germany | Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie | Villingen-Schwenningen | |
Hungary | Orszagos Koranyi TBC es Pulmonologiai Intezet | Budapest | |
Hungary | Koch Robert Korhaz | Edeleny | |
Hungary | Veszprem Megyei Onkormanyzat Tudogyogyintezet | Farkasgyepu | |
Hungary | Vas Megyei Markusovszky Korhaz ; Pulmonology | Szombathely | |
Hungary | Tudogyogyintezet Torokbalint | Torokbalint | |
Hungary | Zala Megyei Korhaz; Dept of Pulmonary Medicine | Zalaegerszeg | |
Israel | Shaare Zedek Medical Center; Oncology Dept | Jerusalem | |
Israel | Meir Medical Center; Oncology | Kfar-Saba | |
Israel | Chaim Sheba Medical Center; Oncology Dept | Ramat Gan | |
Italy | Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica | Aviano | Friuli-Venezia Giulia |
Italy | Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica | Bologna | Emilia-Romagna |
Italy | ASST DI MONZA; Oncologia Medica | Monza | Lombardia |
Italy | Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico | Orbassano | Piemonte |
Italy | A.O.U.I. VERONA-OSPEDALE POLICLINICO G.B. ROSSI BORGO ROMA;ONCOLOGIA MEDICA-d.U. | Verona | Veneto |
Netherlands | Amphia Ziekenhuis | Breda | |
Netherlands | Catharina-ziekenhuis; Longgeneeskunde en Tuberculose | Eindhoven | |
Netherlands | Universitair Medisch Centrum Groningen | Groningen | |
Russian Federation | Regional Oncology Center | Chelyabinsk | |
Russian Federation | Moscow city oncology hospital #62 of Moscow Healthcare Department | Moscow | |
Russian Federation | City Oncology Hospital; Chemotherapy Dept | Nizhny Novgorod | |
Russian Federation | Leningrad Regional Clinical Hospital | St Petersburg | |
Russian Federation | Rsrch Onc Inst of Rosmed Tech; n.a. prof. N.N. Petrov; Dept of Surgery | St. Petersburg | |
Spain | Hospital Nuestra Señora de Sonsoles; servicio de Oncologia | Avila | |
Spain | Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | |
Spain | Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia | Barcelona | |
Spain | Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | |
Spain | Hospital Universitario Puerta de Hierro; Servicio de Oncologia | Madrid | |
Ukraine | Kiev City Clinical Oncology Center | Kiev | |
Ukraine | Volyn Regional Oncology Dispensary | Lutsk | |
Ukraine | State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department | Lviv | |
Ukraine | Crimean Republican Institute; Oncology Clin Dispensary; Chemotherapy Dept | Simferopol | |
Ukraine | Sumy Reg. Clin. Oncological Dispensary; Thoracall Department | Sumy | |
Ukraine | Zaporizhzhia Regional Clinical Oncology Dispensary; Zaporizhzhya State Medical University | Zaporizhzhya | |
United Kingdom | Royal Surrey County Hospital; St. Lukes Cancer Centre | Guildford | |
United Kingdom | Leicester Royal Infirmary; Dept. of Medical Oncology | Leicester | |
United Kingdom | Christie Hospital Nhs Trust; Medical Oncology | Manchester | |
United States | University Cancer & Blood Center, LLC | Athens | Georgia |
United States | Georgia Cancer Specialists | Atlanta | Georgia |
United States | Peachtree Hematology & Oncology Consultants, Pc | Atlanta | Georgia |
United States | Franklin Square Hospital | Baltimore | Maryland |
United States | Alabama Oncology | Birmingham | Alabama |
United States | Lynn Regional Cancer Center West | Boca Raton | Florida |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana Farber Cancer Inst. | Boston | Massachusetts |
United States | Massachusetts General Hospital. | Boston | Massachusetts |
United States | Wellmonth Physician Services | Bristol | Virginia |
United States | Roswell Park Cancer Inst. | Buffalo | New York |
United States | Gabrail Cancer Center | Canton | Ohio |
United States | The Christ Hospital | Cincinnati | Ohio |
United States | Univ Hosp Case Medical Center | Cleveland | Ohio |
United States | Wayne State University; Hemat/Onc, 4HW CRC | Detroit | Michigan |
United States | cCare | Encinitas | California |
United States | San Juan Oncology Associates | Farmington | New Mexico |
United States | Florida Cancer Specialists - Fort Myers (Colonial Center Dr) | Fort Myers | Florida |
United States | University of Texas M.D. Anderson Cancer Center | Houston | Texas |
United States | Hematology-Oncology of Indiana, Pc | Indianapolis | Indiana |
United States | Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy) | Jacksonville | Florida |
United States | Center for Biomedical Research LLC | Knoxville | Tennessee |
United States | Advanced Medical Specialties | Miami | Florida |
United States | The Sarah Cannon Research Inst | Nashville | Tennessee |
United States | Vanderbilt | Nashville | Tennessee |
United States | Kaiser Permanente - Oakland | Oakland | California |
United States | Nebraska Methodist Hospital | Omaha | Nebraska |
United States | Desert Hematology Oncology Group | Rancho Mirage | California |
United States | Va Sierra Nevada Health Care System | Reno | Nevada |
United States | Blue Ridge Cancer Care - Roanoke | Roanoke | Virginia |
United States | Highlands Oncology Group | Rogers | Arkansas |
United States | Kaiser Permanente - Roseville | Roseville | California |
United States | Kaiser Permanente Sacramento Medical Center | Sacramento | California |
United States | Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building) | Saint Petersburg | Florida |
United States | Southern CA Permanente Med Grp | San Diego | California |
United States | Kaiser Permanente | San Francisco | California |
United States | K. Permanente - Santa Clara | Santa Clara | California |
United States | VA Puget Sound Health Care Sys | Seattle | Washington |
United States | Hematology Oncology PC; Bennett Cancer Center | Stamford | Connecticut |
United States | Stockton Hema Onc Med Grp Inc | Stockton | California |
United States | Northwest Medical Specialties | Tacoma | Washington |
United States | Kaiser Permanente - Vallejo | Vallejo | California |
United States | K. Permanente - Walnut Creek | Walnut Creek | California |
United States | Piedmont Hematology Oncology Associates | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Genentech, Inc. |
United States, Argentina, Australia, Brazil, Canada, Chile, France, Germany, Hungary, Israel, Italy, Netherlands, Russian Federation, Spain, Ukraine, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free Survival (PFS) | Up to approximately 2.5 years | ||
Primary | PFS in Participants with Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Alpha (PIK3CA) Amplification | Up to approximately 2.5 years | ||
Primary | PFS in Participants with Phosphatase and Tensin Homolog (PTEN) Loss/Low | Up to approximately 2.5 years | ||
Secondary | Objective Tumor Response | Up to approximately 2.5 years | ||
Secondary | Objective Tumor Response in Participants with PIK3CA Amplification | Up to approximately 2.5 years | ||
Secondary | Objective Tumor Response in Participants with PTEN Loss/low | Up to approximately 2.5 years | ||
Secondary | Duration of Objective Response (DoR) | Up to approximately 2.5 years | ||
Secondary | DoR in Participants with PIK3CA Amplification | Up to approximately 2.5 years | ||
Secondary | DoR in Participants with PTEN Loss/low | Up to approximately 2.5 years | ||
Secondary | Overall Survival (OS) | Up to approximately 2.5 years | ||
Secondary | OS in Participants with PIK3CA Amplification | Up to approximately 2.5 years | ||
Secondary | OS in Participants with PTEN Loss/low | Up to approximately 2.5 years | ||
Secondary | Percentage of Participants with Adverse Events | Up to approximately 4 years |
Status | Clinical Trial | Phase | |
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