Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer

January 7, 2019 updated by: Hoffmann-La Roche

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer

This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel in patients with previously untreated, locally recurrent, or metastatic HER2-negative breast cancer. Patients will be randomized to one of two treatment arms: bevacizumab or placebo. All patients will be given an intravenous (IV) infusion of of paclitaxel (90 mg/m2) for 3 weeks during each 28-day cycle. bevacizumab or placebo (10 mg/kg) will be administered by IV infusion on Days 1 and 15 of each 28-day cycle. Patients will be treated until disease progression, unacceptable toxicity or death from any cause occurs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
481

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma Buenos Aires, Argentina, C1284AEB
        • Hospital Británico de Buenos Aires
      • La Rioja, Argentina, F5300COE
        • Centro Oncologico Riojano Integral (Cori)
      • Pergamino, Argentina, B2700CPM
        • Centro de Investigacion Pergamino SA
      • Quilmes, Argentina, 1878
        • Instituto de Investigaciones Clinicas Quilmes
      • Rosario, Argentina, S2000KZE
        • Instituto de Oncologia de Rosario
      • Rosario, Argentina, 2000
        • Hospital Provincial del Centenario
      • Rosario, Argentina, S2000CVB
        • Instituto CAICI
      • Rosario, Santa FE, Argentina, S2000DSV
        • Sanatorio Parque S.A.
      • Santa Fe, Argentina, 03000
        • ISIS Clinica Especializada
  • Belgium
      • Brasschaat, Belgium, 2930
        • AZ Klina
      • Brussel, Belgium, 1090
        • UZ Brussel
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Gilly (Charleroi), Belgium, 6000
        • GHdC Site Saint-Joseph
      • Mons, Belgium, 7000
        • CHU Ambroise Paré; Hematology and Oncology Department
  • Brazil
    • DF
      • Brasilia, DF, Brazil, 70390-055
        • Clinica de Tratamento e Pesquisa Oncologica - Oncotek
    • RS
      • Passo Fundo, RS, Brazil, 99010-260
        • Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia
      • Porto Alegre, RS, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceicao
      • Porto Alegre, RS, Brazil, 90430-090
        • Clinica de Oncologia de Porto Alegre - CliniOnco
      • Porto Alegre, RS, Brazil, 90110-270
        • Hospital Sao Lucas - PUCRS; Pesquisa Clinica
    • SC
      • Florianopolis, SC, Brazil, 88034-000
        • Centro de Pesquisas Oncologicas - CEPON
      • Itajai, SC, Brazil, 88301-220
        • Clinica de Neoplasias Litoral
    • SP
      • Ribeirao Preto, SP, Brazil, 14048-900
        • Hospital das Clinicas - FMUSP Ribeirao Preto
      • Sao Paulo, SP, Brazil, 22793-080
        • Universidade Federal de São Paulo - UNIFESP
  • Bulgaria
      • Gabrovo, Bulgaria, 5300
        • MHAT Dr. Tota Venkova AD
      • Haskovo, Bulgaria, 6300
        • SHATOD Haskovo EOOD
      • Plovdiv, Bulgaria, 4004
        • Complex Oncological Center - Plovdiv, EOOD
      • Shumen, Bulgaria, 9700
        • Complex Oncological Center - Shumen, EOOD; Department of Chemotherapy
      • Sofia, Bulgaria, 1233
        • SHATOD - Sofia District, EOOD
      • Sofia, Bulgaria, 1303
        • MHAT Serdika, EOOD
      • Sofia, Bulgaria, 1527
        • UMHAT Tsaritsa Yoanna - ISUL, EAD
      • Sofia, Bulgaria, 1784
        • SHATOD - Sofia City, EOOD
      • Varna, Bulgaria, 9010
        • SHATOD Dr. Marko Antonov Markov-Varna, EOOD
      • Veliko Tarnovo, Bulgaria, 5000
        • COC - Veliko Tarnovo
  • Chile
      • Santiago, Chile, 7500921
        • Fundacion Arturo Lopez Perez
      • Santiago, Chile, 7500921
        • Centro de Estudios Oncologicos de Santiago (CEOS) Oncologia
      • Santiago, Chile, 8380000
        • Instituto Nacional del Cancer
      • Viña del Mar, Chile
        • Instituto Oncologico Ltda.
  • Germany
      • Aschaffenburg, Germany, 63739
        • Studienzentrum Aschaffenburg
      • Dortmund, Germany, 44137
        • St. Johannes Hospital; Klinik fuer innere Medizin II, Onkologie, Haematologie
      • Goch, Germany, 47574
        • Wilhelm-Anton-Hospital gGmbH
      • Heidelberg, Germany, 69120
        • Universitatsklinikum Heidelberg
      • Köln, Germany, 50935
        • St. Elisabeth-Krankenhaus
      • Ulm, Germany, 89081
        • Universitaetsklinikum Ulm
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • Azienda Ospedaliera A. Cardarelli
    • Emilia-Romagna
      • Rimini, Emilia-Romagna, Italy, 47923
        • Ospedale Degli Infermi
    • Lombardia
      • Legnago (VR), Lombardia, Italy, 37045
        • Ospedale Mater Salutis
      • Milano, Lombardia, Italy, 20132
        • Ospedale San Raffaele
      • Pavia, Lombardia, Italy, 27100
        • Fondazione Salvatore Maugeri IRCCS
    • Puglia
      • San Giovanni Rotondo, Puglia, Italy, 71013
        • Ospedale Casa Sollievo Della Sofferenza IRCCS
    • Toscana
      • Lido Di Camaiore, Toscana, Italy, 55043
        • Ospedale Versilia
  • Japan
      • Ehime, Japan, 791-0280
        • NHO Shikoku Cancer Center; Dept of Respiratory Medicine
      • Fukuoka, Japan, 811-1395
        • Nho Kyushu Cancer Center
      • Gifu, Japan, 501-1194
        • Gifu University Hospital
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
      • Hyogo, Japan, 663-8501
        • Hyogo College of Medicine Hospital
      • Iwate, Japan, 020-8505
        • Iwate Medical University Hospital
      • Kagoshima, Japan, 892-0833
        • Hakuaikai Sagara Hospital
      • Kanagawa, Japan, 259-1193
        • Tokai University Hospital
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital
      • Kumamoto, Japan, 862-8505
        • Kumamoto City Hospital
      • Miyagi, Japan, 980-8574
        • Tohoku University Hospital
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
      • Osaka, Japan, 589-8511
        • Kindai University Hospital
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute
      • Osaka, Japan, 540-0006
        • NHO Osaka National Hospital
      • Sapporo-shi, Japan, 003-0804
        • NHO Hokkaido Cancer Center
      • Shizuoka-shi, Japan, 420-8527
        • Shizuoka General Hospital
      • Tokyo, Japan, 105-8470
        • Toranomon Hospital
      • Tokyo, Japan, 113-8431
        • Juntendo University Hospital
      • Tokyo, Japan, 113-8677
        • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of, 10408
        • National Cancer Centre
      • Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 6351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center.
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System; Pharmacy
  • Panama
      • Panama, Panama, 0832
        • Centro Hemato Oncologico Panama
      • Panama, Panama
        • Medical Research Centre
  • Romania
      • Bucuresti, Romania, 022328
        • Institutul Oncologic "Prof. Dr. Al. Trestioreanu"
      • Cluj-Napoca, Romania, 400058
        • Medisprof srl
      • Cluj-Napoca, Romania, 400015
        • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca; Radioterapie I - Oncologie
      • Timisoara, Romania, 300239
        • Oncomed SRL
  • Russian Federation
      • Chernihiv, Russian Federation, 14029
        • CTPI Chernihiv Regional Oncological Dispensary
      • Kazan, Russian Federation, 420029
        • SHI Republican Clinical Oncological Dispensary of HM RT
      • Krasnodar, Russian Federation, 350040
        • Regional Clinical Oncology Dispensary
      • Moscow, Russian Federation, 115478
        • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
      • Saint-Petersburg, Russian Federation
        • FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
      • Saint-Petersburg, Russian Federation, 197022
        • City Clinical Oncology Dispensary
      • Saint-Petersburg, Russian Federation, 197101
        • SBEIHPE SSMU n.a. I.P.Pavlov of MOH and SD of RF
      • Samara, Russian Federation, 443031
        • Samara Regional Oncology Dispensary
      • St. Petersburg, Russian Federation, 195271
        • Non-state Healthcare Institution "Road Clinical Hospital of JSC Russian Railways"
  • South Africa
      • Bloemfontein, South Africa, 9301
        • National Hospital; Oncotherapy Dept
      • Cape Town, South Africa, 7570
        • Cape Town Oncology Trials
      • Durban, South Africa, 4091
        • Hopelands Cancer Centre Durban
      • Groenkloof, South Africa, 0181
        • Mary Potter Oncology Centre
      • Hilton, South Africa, 3245
        • Hopelands Cancer Centre
      • Port Elizabeth, South Africa, 6045
        • Cancercare
      • Pretoria, South Africa, 0002
        • University of Pretoria; Department of Medical Oncology
  • Ukraine
      • Cherkassy, Ukraine, 18009
        • CI Cherkasy Regional Oncological Dispensary of Cherkasy RC RC of Clinical Oncology
      • Dnipropetrovsk, Ukraine, 49102
        • CI Dnipropetrovsk CMCH 4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU
      • Donetsk, Ukraine, 83092
        • CCTPI Donetsk Regional Antitumor Center
      • Kyiv, Ukraine, 03115
        • Kyiv Сity Clinical Oncological Center
      • Lutsk, Ukraine, 63000
        • Medical and Prophylactic Institution Volyn Regional Oncological Dispensary
      • Lviv, Ukraine, 79031
        • Lviv State Oncological Regional Treatment and Diagnostic Center
      • Sumy, Ukraine, 40005
        • RCI Sumy Regional Clinical Oncological Dispensary
      • Uzhgorod, Ukraine, 88000
        • CCCH City Oncological Center SHEI Uzhgorod NU
  • United Kingdom
      • Cardiff, United Kingdom, CF14 2TL
        • Velindre Cancer Centre
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital (Wonford)
      • Middlesex, United Kingdom, HA6 2RN
        • Mount Vernon Hospital
      • Peterborough, United Kingdom, PE3 9GZ
        • Peterborough City Hospital
      • Plymouth, United Kingdom, PL6 8BX
        • Derriford Hospital; Clinical Neurology Research Group
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center
    • California
      • Corona, California, United States, 92879
        • Wilshire Oncology Medical Group
      • Glendora, California, United States, 91741
        • Wilshire Oncology Medical Group
      • La Verne, California, United States, 91750
        • Wilshire Oncology Medical Group
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Medical Center; Oncology
      • Palm Springs, California, United States, 92262
        • Tenet Health System Desert Inc
      • Pomona, California, United States, 91767
        • Wilshire Oncology Medical Group; Oncology
      • Rancho Cucamonga, California, United States, 91730
        • Wilshire Oncology Medical Group
      • West Covina, California, United States, 91790
        • Wilshire Oncology Medical Group
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital
    • Florida
      • Deerfield Beach, Florida, United States, 33442
        • Sylvester Comprehensive Cancer Center - Deerfield Beach; Sylvester Cancer Center
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists - Broadway
      • Plantation, Florida, United States, 33322
        • Brcr Medical Center, Inc.
      • Port Saint Lucie, Florida, United States, 34952
        • Hematology Oncology Associates of the Treasure Coast
    • Georgia
      • Athens, Georgia, United States, 30607
        • Northeast Georgia Cancer Care LLC
      • Atlanta, Georgia, United States, 30318
        • Peachtree Hematology & Oncology Consultants, Pc
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Kaiser Foundation Hospital; Dr. Eron's Office
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • IU Cancer Pavilion
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center
      • Columbia, Maryland, United States, 21044
        • Maryland Oncology Hematology, P.A.
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic Inc. - PARENT ACCOUNT
    • Mississippi
      • New Albany, Mississippi, United States, 38652
        • The Jones Clinic, PC
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Missouri Cancer Associates
      • Saint Louis, Missouri, United States, 63110
        • Washington University; Center for Adv Medicine
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • Ohio
      • Middletown, Ohio, United States, 45042
        • Signal Point Clinical; Research Center, LLC
      • Sylvania, Ohio, United States, 43560
        • ProMedica Hickman Cancer Center at Flower Hospital; Hickman Cancer Center
      • Toledo, Ohio, United States, 43614
        • University of Toledo; Dept. of Medicine
    • Pennsylvania
      • Leesburg, Pennsylvania, United States, 20176
        • Virginia Cancer Specialists - Leesburg
      • Philadelphia, Pennsylvania, United States, 19106
        • Pennsylvania Oncology Hematology Associates, Inc.; PA Oncology & Hematology
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina; Division of Hematology-Oncology
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • SCRI-Tennessee Oncology
    • Texas
      • Dallas, Texas, United States, 75230
        • Texas Oncology-Medical City Dallas
      • Dallas, Texas, United States, 75231
        • Texas Oncology, P.A. - Dallas Presbyterian
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology, P.A. - Fort Worth
      • Fort Worth, Texas, United States, 76132
        • Texas Oncology- Southwest Fort Worth
      • Galveston, Texas, United States, 77555
        • Univ of Texas Medical Branch
      • Garland, Texas, United States, 77060
        • Texas Oncology, P.A. - Garland
      • Kerrville, Texas, United States, 78028
        • Cancer Care Centers of S Texas
      • Longview, Texas, United States, 75601
        • Texas Oncology- Longview Cancer Center
      • McAllen, Texas, United States, 78503
        • Texas Oncology, P.A. - McAllen; South Texas Cancer Center-McAllen
      • Plano, Texas, United States, 75093
        • Texas Oncology Plano West
      • San Antonio, Texas, United States, 78217
        • Cancer Care Centers of South Texas
      • San Antonio, Texas, United States, 78212
        • Cancer Care Centers of South Texas
      • San Antonio, Texas, United States, 78258
        • CancerCare Centers of South Texas
      • The Woodlands, Texas, United States, 77060
        • Texas Oncology, P.A. - Tyler
      • The Woodlands, Texas, United States, 77060
        • Texas Oncology, P.A.
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Virginia Cancer Specialists - Alexandria
      • Arlington, Virginia, United States, 22205
        • Fairfax Northern Virginia Hematology-Oncology PC
      • Bristol, Virginia, United States, 24201
        • Wellmonth Physician Services
      • Chesapeake, Virginia, United States, 23320
        • Virginia Oncology Associates - Chesapeake
      • Christiansburg, Virginia, United States, 24073
        • Oncology & Hematology Associates of SW Va Inc. - Market Street
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists, PC
      • Fredericksburg, Virginia, United States, 22408
        • Hematology Oncology Associates of Fredericksburg, Inc.
      • Gainesville, Virginia, United States, 20155
        • Virginia Cancer Specialists - Gainsville
      • Hampton, Virginia, United States, 23666
        • Virginia Oncology Associates - Hampton
      • Low Moor, Virginia, United States, 24457
        • Oncology and Hematology Assoc. of SW VA, Inc. - Low Moor
      • Newport News, Virginia, United States, 23606
        • Virginia Oncology Associates - New Port News
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
      • Roanoke, Virginia, United States, 24014
        • Oncology & Hematolgy Associates of SW Va Inc. - Roanoke
      • Salem, Virginia, United States, 77060
        • Oncology and Hematology Assoc. of SW VA, Inc.
      • Virginia Beach, Virginia, United States, 23456
        • Virginia Oncology Associates - Virginia Beach
      • Wytheville, Virginia, United States, 24382
        • Oncology and Hematology Assoc. of SW VA, Inc. - Wytheville
    • Washington
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties, PLLC; Research Department
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University; Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed, HER2-negative adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.
  • ECOG performance status of 0 or 1
  • For women of childbearing potential, use of an acceptable and effective method of non-hormonal contraception
  • For patients who have received recent radiotherapy, recovery prior to randomization from any significant acute toxicity, and radiation treatments have to be completed more than 3 weeks from randomization

Exclusion Criteria:

Disease-Specific Exclusions:

  • HER2-positive status
  • Prior chemotherapy for locally recurrent or metastatic disease
  • Prior hormonal therapy < 2 weeks prior to randomization
  • Prior adjuvant or neo-adjuvant chemotherapy is allowed, provided its conclusion has been for at least 12 months prior to randomization
  • Investigational therapy within 28 days of randomization

General Medical Exclusions:

  • Life expectancy of < 12 weeks
  • Inadequate organ function
  • Uncontrolled serious medical or psychiatric illness
  • Active infection requiring intravenous (IV) antibiotics at screening
  • Pregnancy or lactation
  • History of other malignancies within 5 years prior to screening, except for tumors with a negligible risk for metastasis or death

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A
Paclitaxel + Bevacizumab [Avastin]
Drug: Bevacizumab [Avastin]
Intravenous repeating dose
Drug: Paclitaxel
Intravenous repeating dose
Experimental: B
Paclitaxel + Placebo
Drug: Paclitaxel
Intravenous repeating dose
Drug: Placebo
Intravenous repeating dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population
Time Frame: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)
Tumor assessment was performed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator. Disease progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), unequivocal progression of existing non-target lesions, or presence of new lesions.
Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)
Progression Free Survival (PFS) in ITT Population
Time Frame: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)
PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.
Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)
Percentage of Participants With Progression or Death in High Baseline Plasma Vascular Endothelial Growth Factor-A (VEGF-A) ITT Population
Time Frame: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)
Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions.
Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)
PFS in High Baseline Plasma VEGF-A ITT Population
Time Frame: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)
PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.
Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Died - ITT Population
Time Frame: From randomization till death or clinical cut-off (up to 244 weeks)
From randomization till death or clinical cut-off (up to 244 weeks)
Overall Survival (OS) - ITT Population
Time Frame: From randomization till death or clinical cut-off (up to 244 weeks)
OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.
From randomization till death or clinical cut-off (up to 244 weeks)
Percentage of Participants Who Died - High Baseline Plasma VEGF-A ITT Population
Time Frame: From randomization till death or clinical cut-off (up to 244 weeks)
From randomization till death or clinical cut-off (up to 244 weeks)
OS - High Baseline Plasma VEGF-A ITT Population
Time Frame: From randomization till death or clinical cut-off (up to 244 weeks)
OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.
From randomization till death or clinical cut-off (up to 244 weeks)
Percentage of Participants With an Objective Response - ITT Population
Time Frame: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)
Objective response was defined as having a Complete Response (CR) or Partial Response (PR) according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, computed tomography (CT), or magnetic resonance imaging (MRI).
Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)
Percentage of Participants With an Objective Response - High Baseline Plasma VEGF-A ITT Population
Time Frame: Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)
Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, CT, or MRI.
Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)
Duration of Response - ITT Population
Time Frame: Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 117.7 weeks)
Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.
Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 117.7 weeks)
Duration of Response - High Baseline Plasma VEGF-A ITT Population
Time Frame: Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 111.3 weeks)
Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.
Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 111.3 weeks)
Percentage of Participants Who Were Alive at 1 Year - ITT Population
Time Frame: 1 year
1 year
Secondary: Percentage of Participants Who Were Alive at 1 Year - High Baseline Plasma VEGF-A ITT Population
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 27, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 21, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GO25632
  • 2011-005335-97 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings