Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects (INTORACT)

March 25, 2016 updated by: Pfizer

Phase 3b, Randomized, Open-Label Study Of Bevacizumab + Temsirolimus Vs. Bevacizumab + Interferon-Alfa As First-Line Treatment In Subjects With Advanced Renal Cell Carcinoma

Primary objective: Comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response rate (independently assessed), and overall survival.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

791

Phase

  • 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
      • Santa Fe, Argentina, 3000
        • ISIS Clinica Especializado
    • Santa Fé
      • Rosario, Santa Fé, Argentina, S2000KZE
        • Centro Oncologico Rosario
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, T4000IAK
        • Centro Medico San Roque
  • Australia
      • Kurralta Park, Australia, 5037
        • Cancer Care SA
      • South Brisbane, Australia, QLD 4101
        • Mater Private Hospital
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Mater Adult Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
      • Kurralta Park, South Australia, Australia, 5037
        • Ashford Cancer Center Research
  • Belgium
      • Antwerpen, Belgium, 2020
        • ZNA Middelheim
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Hasselt, Belgium, 3500
        • Jessa Ziekenhuis - campus Virga Jessa
      • Mont-Godinne, Belgium, 5530
        • Cliniques Universitaires de Mont-Godinne UCL
  • Brazil
      • Porto Alegre, Brazil, 90050-170
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
      • Rio de Janeiro, Brazil, 20231-050
        • Instituto Nacional Do Câncer - Inca
    • GO
      • Goiania, GO, Brazil, 74075-040
        • Centro Goiano de Oncologia
      • Goiania, GO, Brazil, 74130-015
        • Centro Goiano de Oncologia - CGO
      • Goiania, GO, Brazil, 74140-050
        • ProCura - Centro Goiano de Pesquisa Clínica Ltda
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20230-130
        • Instituto Nacional de Câncer - INCA
    • RS
      • Ijui, RS, Brazil, 98700-000
        • Associacao Hospital de Caridade Ijui
      • Porto Alegre, RS, Brazil, 90035-003
        • Hospital de Clínicas de Porto Alegre
      • Porto Alegre, RS, Brazil, 90430-090
        • Clinica de Oncologia de Porto Alegre - Sociedade Simples Ltda.
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90430-090
        • Clínica de Oncologia de Porto Alegre Sociedade Simples Ltda
    • SP
      • Piracicaba, SP, Brazil, 13419-155
        • Instituto de Oncologia de Piracicaba S/S Ltda
      • Sao Paulo, SP, Brazil, 01246-000
        • Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira - ICESP
    • Sao Paulo
      • Barretos, Sao Paulo, Brazil, 14784-400
        • Fundação Pio XII - Hospital de Câncer de Barretos
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Odette Cancer Centre, Sunnybrook Health Sciences Centre
    • Quebec
      • Rimouski, Quebec, Canada, G5L 5T1
        • Centre de Sante et de Services Sociaux de Rimouski - Neigette
  • Chile
      • Santiago, Chile
        • Fundación Arturo López Pérez
      • Santiago, Chile
        • Instituto Clinico Oncologico del Sur
    • Region Metropolitana / Chile
      • Santiago, Region Metropolitana / Chile, Chile, 8380455
        • Instituto Nacional del Cancer
  • Colombia
    • Risaralda
      • Pereira, Risaralda, Colombia
        • Oncologos del Occidente S.A
  • Czech Republic
      • Brno, Czech Republic, 656 53
        • Masarykuv onkologicky ustav
      • Olomouc, Czech Republic, 775 20
        • Fakultni nemocnice Olomouc
      • Usti nad Labem, Czech Republic, 401 13
        • Krajska Zdravotni, a.s.
    • Ceska republika
      • Jicin, Ceska republika, Czech Republic, 506 43
        • Oblastni nemocnice Jicin a s
  • France
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Hyères, France, 83400
        • Clinique Sainte Marguerite
      • Le Chesnay, France, 78157
        • Hôpital André Mignot
      • Nimes, France, 30907
        • Centre médical Oncogard
      • Poitiers Cedex, France, 86021
        • CHU de Poitiers
      • Rouen Cedex, France, 76031
        • CHU de Rouen
      • Saint-Herblain-Nantes, France, 44805
        • Centre René Gauducheau
      • Suresnes, France, 92151
        • Hopital Foch
      • Villejuif Cedex, France, 94805
        • Institut Gustave Roussy
  • Germany
      • Berlin, Germany, 10967
        • Vivantes Klinikum am Urban, Neztwerk fuer Gesundheit GmbH
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg Eppendorf
      • Hannover, Germany, 30449
        • Klinikum Region Hannover, Krankenhaus Siloah
      • Muenchen, Germany, 81675
        • TU Muenchen, rechts der Isar
  • Hong Kong
      • Chai Wan, Hong Kong
        • Pamela Youde Nethersole Eastern Hospital
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital
  • Hungary
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet
      • Budapest, Hungary, 1145
        • Uzsoki Utcai Kórház
      • Gyor, Hungary, 9024
        • Petz Aladár Megyei Oktató Kórház
      • Nyiregyhaza, Hungary, 4400
        • Jósa András Oktató Kórház Nonprofit Kft.
      • Szeged, Hungary, 6725
        • Szegedi Tudomanyegyetem, Urologiai Klinika
      • Veszprem, Hungary, 8200
        • Veszprem Megyei Csolnoky Ferenc
  • India
    • Gujarat
      • Ahmedabad, Gujarat, India, 380009
        • Vedanta Institute Of Medical Sciences
    • Karnataka
      • Bangalore, Karnataka, India, 560027
        • HealthCare Global Enterprises Limited
    • Kerala
      • Kochi, Kerala, India, 682304
        • Lakeshore Hospital & Research Center Limited
    • Madhya Pradesh
      • Bhopal, Madhya Pradesh, India, 462001
        • Jawaharlal Nehru Cancer Hospital, Department of Medical Oncology
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Tata Memorial Center
      • Navi Mumbai, Maharashtra, India, 410210
        • Tata Memorial Centre
      • Pune, Maharashtra, India, 411001
        • Jehangir Hospital
    • Rajasthan
      • Jaipur, Rajasthan, India, 302013
        • SEAROC Cancer Centre
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600035
        • Apollo Hospital
    • Trivandrum
      • Kerela, Trivandrum, India, 695011
        • Regional Cancer Centre
  • Italy
      • Bari, Italy, 70124
        • Divisione di Urologia, Azienda Ospedaliera Policlinico Consorziale di Bari
      • Chieti, Italy, 66013
        • Sezione di Oncologia Medica Centro di Ricerca Clinica
      • Modena, Italy, 41100
        • Unità Operativa di Oncologia, Azienda Ospedaliera Policlinico di Modena
      • Modena, Italy, 41124
        • Farmacia del Comitato Etico Provinciale di Modena
      • Perugia, Italy, 06132
        • Struttura Complessa di Oncologia Medica Ospedale Santa Maria della Misericordia
      • Roma, Italy, 00144
        • IFO- Istituti Fisioterapici Ospitalieri
      • Terni, Italy, 05100
        • Azienda Ospedaliera S. Maria
  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Yonsei University Health System-Severance Hospital
    • Korea
      • Seoul, Korea, Korea, Republic of, 135-710
        • Samsung Medical Center
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
  • Mexico
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37000
        • Hospital Aranda de La Parra
  • Netherlands
      • Hoofddorp, Netherlands, 2134 TM
        • Spaarne Ziekenhuis
  • Poland
      • Gdansk, Poland, 80952
        • Uniwersyteckie Centrum Kliniczne
      • Krakow, Poland, 31-826
        • Szpital Specjalistyczny im. L. Rydygiera Sp. z o.o.
      • Lublin, Poland, 20-090
        • Centrum Onkologii Ziemi Lubelskiej im. sw Jana z Dukli
      • Poznan, Poland, 60-569
        • Szpital Kliniczny Przemienienia Pańskiego UM im. Karola Marcinkowskiego w Poznaniu
      • Warszawa, Poland, 02-781
        • Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie
      • Warszawa, Poland, 04-125
        • Centrum Medyczne Ostrobramska NZOZ "Magodent"
      • Warszawa, Poland, 04-141
        • Wojskowy Instytut Medyczny, Pracownia Badan Cynnosciowych Ukladu Oddechowego, Klinika Chorob Wewnetr
      • Warszawa, Poland, 04-141
        • Wojskowy Intsytut Medyczny, Zaklad Diagnostyki Laboratoryjnej CSK MON
      • Warszawa, Poland, 04-141
        • Wojskowy Intsytut Medyczny, Zaklad Medycyny Nuklearnej CSK MON
  • Portugal
      • Porto, Portugal, 4200-319
        • Hospital de San Joao
      • Porto, Portugal, 4200-319
        • Hospital de Sao Joao
  • Russian Federation
      • Kazan, Russian Federation, 420029
        • Republican Clinical Oncology Dispensary of Minzdrav of Tatarstan Republic
      • Moscow, Russian Federation, 105077
        • Chair of Radiology and Radiotherapy
      • Moscow, Russian Federation, 115478
        • N.N. Blokhin Russian Cancer Research Center, Department of Clinical Pharmacology and Chemotherapy
      • Moscow, Russian Federation, 115478
        • N.N. Blokhin Russian Cancer Research Center, Department of Urology
      • Moscow, Russian Federation, 125284
        • Moscow Scientific Research Oncology Institute P.A. Herzen
      • Nizhni Novgorod, Russian Federation, 603109
        • Privolzhskiy District Medical Center of Federal Biomedical Agency
      • Pesochny, Saint-Petersburg, Russian Federation, 197758
        • Scientific Research Institute of Oncology N.N. Petrov
      • Saint-Petersburg, Russian Federation, 196247
        • City Hospital No.26
      • Saint-Petersburg, Russian Federation, 199106
        • City Pokrovskaya Hospital
    • Kaluga region
      • Obninsk, Kaluga region, Russian Federation, 249036
        • Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia
    • Leningradskaya oblast
      • Saint-Petersburg, Leningradskaya oblast, Russian Federation, 188663
        • Leningrad Regional Oncology Dispensary
  • Serbia
      • Belgrade, Serbia, 11000
        • Military Medical Academy
      • Belgrade, Serbia, 11000
        • Clinical Center of Serbia
      • Belgrade, Serbia, 11000
        • Institute for Oncology and Radiology of Serbia
  • Singapore
      • Singapore, Singapore, 169610
        • National Cancer Centre Singapore
  • Slovakia
      • Banska Bystrica, Slovakia, 974 01
        • Fakultna Nemocnica s poliklinikou F D Roosevelta
      • Banska Bystrica, Slovakia, 974 01
        • Oddelenie funkcnej diagnostiky
      • Bratislava, Slovakia, 826 06
        • Klinika pneumologie a ftiziologie FNsP LFUK
      • Bratislava, Slovakia, 833 05
        • Fakultna Nemocnica s poliklinikou akad L Derera
      • Martin, Slovakia, 036 59
        • Klinica nuklcarncj mediciny
      • Martin, Slovakia, 036 59
        • Klinika nuklearnej mediciny JLF UK a Martinskej fakultnej nemocnice
      • Martin, Slovakia, 036 59
        • Klinika tuberkulozy a plucnych chorob UK JLF a Martinskej fakultnej nemocince
      • Skalica, Slovakia, 909 82
        • Nemocnica s poliklinikou Skalica
      • Zilina, Slovakia, 012 07
        • KK MED, s.r.o.
      • Zilina, Slovakia, 012 07
        • MEDIVASA s.r.o.
      • Zilina, Slovakia, 012 07
        • Nemocnica s poliklinikou Zilina
  • South Africa
      • Parktown, South Africa, 2193
        • University of the Witwatersrand Oncology
      • Port Elizabeth, South Africa, 6006
        • Langenhoven Drive Oncology Centre
      • Pretoria, South Africa, 0084
        • Dr. Fourie & Voges
    • Cape Town
      • Kraaifontein, Cape Town, South Africa, 7570
        • GVI Oncology Trial Unit
    • Durban
      • Mayville, Durban, South Africa, 4001
        • Westridge Medical Centre
    • Pretoria
      • Hatfield, Pretoria, South Africa, 0083
        • Pretoria Urology Hospital
    • Western Cape
      • Panorama, Cape Town, Western Cape, South Africa, 7500
        • Panorama Medical Centre
  • Spain
      • Barcelona, Spain, 08025
        • Hospital Sant Creu i Sant Pau
      • Barcelona, Spain, 8003
        • Hospital del Mar de Barcelona
      • Madrid, Spain, 28050
        • Hospital de Madrid Norte-Sanchinarro
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncologia
    • Barcelona
      • L'hospitalet de Llobregat, Barcelona, Spain, 08907
        • Institut Catala Doncologia
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
  • Taiwan
      • Taichung, Taiwan, 404
        • China Medical University Hospital
      • Taipei TOC, Taiwan, 100
        • National Taiwan University Hospital
      • Tao Yuan, Taiwan, 333
        • Division of Oncology
    • ROC
      • Taipei, ROC, Taiwan, 11217
        • Veterans General Hospital-Taipei
    • Tapei
      • Neihu, Tapei, Taiwan, 114
        • Tri-Service General Hospital
  • Ukraine
      • Chenivtsi, Ukraine, 58013
        • Universitet, kafedra onkologyy
      • Chernovtsi, Ukraine, 58001
        • A.P Romodanov Itstitut nejrohirurhii
      • Donetsk, Ukraine, 83003
        • Uchbobo-naukovyi likuvalnyi kompleks DDMU im. M.Gor'kogo
      • Donetsk, Ukraine, 83092
        • Donetskyy Oblasyy protypukhlynnyy Tsenter
      • Donetsk, Ukraine, 83099
        • Donetske Obl. clinico-teritorial'ne medichne ob'yednannya
      • Kiev, Ukraine, 01033
        • "State Institution ""Institute for Occupational Health of the
      • Kiev, Ukraine, 03115
        • R.E.Kavetsky Institute of experimental pathology, oncology and radiobiology NAS of Ukraine,Laborator
      • Kiyv, Ukraine, 04050
        • A.P Romodanov Itstitut nejrohirurhii
      • Medychna vul., Ivano-Frankivsk, Ukraine, 76018
        • Oblasnyy onkologychnyy dispanser, onkourologichne viddilennya, Ivano-Frankivskiy Derzhavniy Medichni
  • United Kingdom
      • London, United Kingdom, SE1 7EH
        • Guy's Hospital
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Southampton General Hospital
    • Manchester
      • Withington, Manchester, United Kingdom, M20 4BX
        • Christie Hospital
    • North Yorkshire
      • Leeds, North Yorkshire, United Kingdom, LS9 7TF
        • University of Leeds
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Hematology Oncology Services of Arkansas
    • California
      • Chula Vista, California, United States, 91911
        • South County Hematology/Oncology
      • La Mesa, California, United States, 91942
        • Cancer Center Oncology Medical Group
      • Los Angeles, California, United States, 90095
        • UCLA
      • Los Angeles, California, United States, 90095-1694
        • UCLA Medical Center
      • Los Angeles, California, United States, 90095-6984
        • UCLA
      • Oceanside, California, United States, 92056
        • North County Oncology Medical Clinic
      • San Diego, California, United States, 92123
        • Medical Oncology Associates - Sd
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital Investigational Pharmacy
      • San Diego, California, United States, 92123
        • Sharp Rees-Stealy
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
      • San Francisco, California, United States, 94115
        • Pacific Hematology/Oncology Associates
      • San Francisco, California, United States, 94118
        • Cohen & Hufford MD's INC
      • San francisco, California, United States, 94115
        • San Francisco Oncology Associates
    • Mississippi
      • New Albany, Mississippi, United States, 38652
        • The Jones Clinic, PC
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Edmond Oncology Center
      • Oklahoma City, Oklahoma, United States, 73104
        • OU Medical Center
      • Oklahoma City, Oklahoma, United States, 73104
        • OU Physician's Building
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The Jones Clinic, PC
      • Nashville, Tennessee, United States, 37232
        • The Vanderbilt Clinic
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Seattle, Washington, United States, 96195
        • University of Washington Medical Center
      • Seattle, Washington, United States, 98109-1023
        • Seattle Cancer Care Alliance

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically and/or cytologically confirmed to have advanced renal cell carcinoma (RCC)
  • Majority component of conventional clear-cell type is mandatory
  • At least 1 measurable lesion (per RECIST)

Exclusion Criteria:

  • Prior systemic treatment for RCC
  • Evidence of current or prior central nervous system (CNS) metastases
  • Cardiovascular disease
  • Pregnant or nursing women
  • Additional criteria applies

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly
Drug: Bevacizumab
Bevacizumab 10 mg/kg intravenous (IV) q8wks
Other Names:
  • Torisel
Drug: Temsirolimus
Temsirolimus 25 mg IV weekly
Active Comparator: 2
Bevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW
Drug: Bevacizumab
Bevacizumab 10 mg/kg intravenous (IV) q8wks
Other Names:
  • Torisel
Drug: Interferon-Alfa 9MU
Interferon-Alfa 9MU SC TIW

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS): Independent-Assessment
Time Frame: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by independent imaging reviewers using Response Evaluation Criteria in Solid Tumors (RECIST) criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.
Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS): Investigator-Assessment
Time Frame: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by investigator imaging reviewers using RECIST criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.
Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
Percentage of Participants With Objective Response (Complete Response/Partial Response): Independent-Assessment
Time Frame: Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
Overall Survival (OS)
Time Frame: Baseline until death due to any cause, assessed every 8 weeks (up to cut-off date: 19 April 2012)
OS was defined as the time from randomization to death due to any cause, censored at the last date known alive. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Baseline until death due to any cause, assessed every 8 weeks (up to cut-off date: 19 April 2012)

Collaborators and Investigators

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

Sponsor

Pfizer

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

April 1, 2008

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

February 28, 2008

First Submitted That Met QC Criteria

February 28, 2008

First Posted (Estimate)

March 7, 2008

Study Record Updates

Last Update Posted (Estimate)

April 27, 2016

Last Update Submitted That Met QC Criteria

March 25, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3066K1-3311
  • B1771006 (Other Identifier: Alias Study Number)
  • 2007-003793-26 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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