Clinical trial NCT01493843: Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab With and Without Pictilisib in Previously Untreated Advanced or Recurrent Non-small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-16
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to approximately 2.5 years
measure: PFS in Participants with Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Alpha (PIK3CA) Amplification
timeFrame: Up to approximately 2.5 years
measure: PFS in Participants with Phosphatase and Tensin Homolog (PTEN) Loss/Low
timeFrame: Up to approximately 2.5 years
Secondary outcomes:
measure: Objective Tumor Response
timeFrame: Up to approximately 2.5 years
measure: Objective Tumor Response in Participants with PIK3CA Amplification
timeFrame: Up to approximately 2.5 years
measure: Objective Tumor Response in Participants with PTEN Loss/low
timeFrame: Up to approximately 2.5 years
measure: Duration of Objective Response (DoR)
timeFrame: Up to approximately 2.5 years
measure: DoR in Participants with PIK3CA Amplification
timeFrame: Up to approximately 2.5 years
measure: DoR in Participants with PTEN Loss/low
timeFrame: Up to approximately 2.5 years
measure: Overall Survival (OS)
timeFrame: Up to approximately 2.5 years
measure: OS in Participants with PIK3CA Amplification
timeFrame: Up to approximately 2.5 years
measure: OS in Participants with PTEN Loss/low
timeFrame: Up to approximately 2.5 years
measure: Percentage of Participants with Adverse Events
timeFrame: Up to approximately 4 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Oncology
state: Alabama
city: Rogers
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Encinitas
country: United States
facility: cCare
state: California
city: Oakland
country: United States
facility: Kaiser Permanente - Oakland
state: California
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Group
state: California
city: Roseville
country: United States
facility: Kaiser Permanente - Roseville
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Sacramento Medical Center
state: California
city: San Diego
country: United States
facility: Southern CA Permanente Med Grp
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente
state: California
city: Santa Clara
country: United States
facility: K. Permanente - Santa Clara
state: California
city: Stockton
country: United States
facility: Stockton Hema Onc Med Grp Inc
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente - Vallejo
state: California
city: Walnut Creek
country: United States
facility: K. Permanente - Walnut Creek
state: California
city: Stamford
country: United States
facility: Hematology Oncology PC; Bennett Cancer Center
state: Connecticut
city: Boca Raton
country: United States
facility: Lynn Regional Cancer Center West
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - Fort Myers (Colonial Center Dr)
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
state: Florida
city: Miami
country: United States
facility: Advanced Medical Specialties
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood Center, LLC
state: Georgia
city: Atlanta
country: United States
facility: Peachtree Hematology & Oncology Consultants, Pc
state: Georgia
city: Atlanta
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Indianapolis
country: United States
facility: Hematology-Oncology of Indiana, Pc
state: Indiana
city: Baltimore
country: United States
facility: Franklin Square Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital.
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Inst.
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University; Hemat/Onc, 4HW CRC
state: Michigan
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Reno
country: United States
facility: Va Sierra Nevada Health Care System
state: Nevada
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
city: Buffalo
country: United States
facility: Roswell Park Cancer Inst.
state: New York
city: Winston-Salem
country: United States
facility: Piedmont Hematology Oncology Associates
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Univ Hosp Case Medical Center
state: Ohio
city: Knoxville
country: United States
facility: Center for Biomedical Research LLC
state: Tennessee
city: Nashville
country: United States
facility: The Sarah Cannon Research Inst
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt
state: Tennessee
city: Houston
country: United States
facility: University of Texas M.D. Anderson Cancer Center
state: Texas
city: Bristol
country: United States
facility: Wellmonth Physician Services
state: Virginia
city: Roanoke
country: United States
facility: Blue Ridge Cancer Care - Roanoke
state: Virginia
city: Seattle
country: United States
facility: VA Puget Sound Health Care Sys
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
city: Cordoba
country: Argentina
facility: Clinica Universitaria Reina Fabiola
city: La Plata
country: Argentina
facility: Instituto FIDES
city: Santa Fe
country: Argentina
facility: Isis Centro Especializado de Luces; Oncology
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital; Sydney Cancer Centre
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent'S Hospital
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle; Medical Oncology
state: New South Wales
city: Bedford Park
country: Australia
facility: Flinders Medical Centre; Medical Oncology
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital; Medical Oncology
state: Tasmania
city: Footscray
country: Australia
facility: Footscray Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital; Hematology and Medical Oncology
state: Victoria
city: Salvador
country: Brazil
facility: Centro de Oncologia da Bahia - CENOB
state: BA
city: Brasilia
country: Brazil
facility: Clinica de Tratamento e Pesquisa Oncologica - Oncotek
state: DF
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer - INCa; Oncologia
state: RJ
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra O Câncer
state: RN
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericordia de Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Mae de Deus
state: RS
city: Florianopolis
country: Brazil
facility: Centro de Pesquisas Oncologicas - CEPON
state: SC
city: Jau
country: Brazil
facility: Hospital Amaral Carvalho
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
state: SP
city: Sorocaba
country: Brazil
facility: Instituto de Oncologia de Sorocaba - CEPOS
state: SP
city: Montreal
country: Canada
facility: Mcgill University - Royal Victoria Hospital; Oncology
state: Quebec
city: Montreal
country: Canada
facility: Hopital du Sacre-Coeur
state: Quebec
city: Santiago
country: Chile
facility: Clinica Santa Maria
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez
city: Temuco
country: Chile
facility: Instituto Oncologico del sur
city: Viña del Mar
country: Chile
facility: Hospital Clinico Vina del Mar
city: Brest
country: France
facility: Hopital Morvan
city: Le Mans
country: France
facility: Clinique Victor Hugo; Radiotherapie
city: Nantes
country: France
facility: Clinique Catherine de Sienne; Service de cancérologie
city: Saint Herblain
country: France
facility: Ico Rene Gauducheau; Oncologie
city: Villefranche-sur-Saone
country: France
facility: Centre Hospitalier de Villefranche sur Saone
city: Villejuif
country: France
facility: Institut Gustave Roussy; Departement Oncologie Medicale
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH; Abteilung Onkologie und Hämatologie
city: Gauting
country: Germany
facility: Asklepios-Fachkliniken Muenchen-Gauting; Onkologie
city: Grosshansdorf
country: Germany
facility: Krankenhaus Grosshansdorf;Pneumologie & Thoraxchirurgie
city: Karlsruhe
country: Germany
facility: St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie
city: Budapest
country: Hungary
facility: Orszagos Koranyi TBC es Pulmonologiai Intezet
city: Edeleny
country: Hungary
facility: Koch Robert Korhaz
city: Farkasgyepu
country: Hungary
facility: Veszprem Megyei Onkormanyzat Tudogyogyintezet
city: Szombathely
country: Hungary
facility: Vas Megyei Markusovszky Korhaz ; Pulmonology
city: Torokbalint
country: Hungary
facility: Tudogyogyintezet Torokbalint
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Korhaz; Dept of Pulmonary Medicine
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center; Oncology Dept
city: Kfar-Saba
country: Israel
facility: Meir Medical Center; Oncology
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center; Oncology Dept
city: Bologna
country: Italy
facility: Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica
state: Emilia-Romagna
city: Aviano
country: Italy
facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
state: Friuli-Venezia Giulia
city: Monza
country: Italy
facility: ASST DI MONZA; Oncologia Medica
state: Lombardia
city: Orbassano
country: Italy
facility: Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
state: Piemonte
city: Verona
country: Italy
facility: A.O.U.I. VERONA-OSPEDALE POLICLINICO G.B. ROSSI BORGO ROMA;ONCOLOGIA MEDICA-d.U.
state: Veneto
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina-ziekenhuis; Longgeneeskunde en Tuberculose
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Chelyabinsk
country: Russian Federation
facility: Regional Oncology Center
city: Moscow
country: Russian Federation
facility: Moscow city oncology hospital #62 of Moscow Healthcare Department
city: Nizhny Novgorod
country: Russian Federation
facility: City Oncology Hospital; Chemotherapy Dept
city: St Petersburg
country: Russian Federation
facility: Leningrad Regional Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: Rsrch Onc Inst of Rosmed Tech; n.a. prof. N.N. Petrov; Dept of Surgery
city: Avila
country: Spain
facility: Hospital Nuestra Señora de Sonsoles; servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia
city: Kiev
country: Ukraine
facility: Kiev City Clinical Oncology Center
city: Lutsk
country: Ukraine
facility: Volyn Regional Oncology Dispensary
city: Lviv
country: Ukraine
facility: State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department
city: Simferopol
country: Ukraine
facility: Crimean Republican Institute; Oncology Clin Dispensary; Chemotherapy Dept
city: Sumy
country: Ukraine
facility: Sumy Reg. Clin. Oncological Dispensary; Thoracall Department
city: Zaporizhzhya
country: Ukraine
facility: Zaporizhzhia Regional Clinical Oncology Dispensary; Zaporizhzhya State Medical University
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital; St. Lukes Cancer Centre
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary; Dept. of Medical Oncology
city: Manchester
country: United Kingdom
facility: Christie Hospital Nhs Trust; Medical Oncology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: