A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer
NCT ID: NCT01420081
Last Updated: 2019-01-08
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
67 participants
INTERVENTIONAL
2012-01-19
2015-12-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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B
PI3K Basal, IV Compound
PF-05212384
154mg IV weekly
C
PI3K Activated, Oral Compound
PF-05212384
154mg IV weekly
F
Japanese lead in cohort, IV compound
PF-05212384
154mg IV weekly
Interventions
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PF-05212384
154mg IV weekly
PF-05212384
154mg IV weekly
PF-05212384
154mg IV weekly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Disease progression following one or two lines of prior treatment with platinum containing chemotherapy
* Tumor tissue available at time of screening for PI3K analysis
* Adequate performance status
* Adequate glucose control, bone marrow, kidney, liver, and heart function
Exclusion Criteria
* Prior therapy with an agent known to be a PI3K, and or mTOR and or AKT inhibitor
* Active brain metastases
18 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Alabama at Birmingham, IDS Pharmacy
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California Medical Center
La Jolla, California, United States
Moores UC San Diego Cancer Center
La Jolla, California, United States
University of California Medical Center
San Diego, California, United States
Mercy Hospital
Miami, Florida, United States
Mercy Research Institute
Miami, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University of Chicago Medicine Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, United States
University of Kansas
Fairway, Kansas, United States
University of Kansas Hospital
Kansas City, Kansas, United States
University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas, United States
Mary Bird Perkins Cancer Center at St. Tammany Parish Hospital
Covington, Louisiana, United States
Women's Cancer Care
Covington, Louisiana, United States
Women's Cancer Care
Metairie, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Peter MacCallum Cancer Centre, Division of Cancer Madicine
East Melbourne, Victoria, Australia
Foothills Medical Center
Calgary, Alberta, Canada
Tom Baker Cancer Centre
Calgary, Alberta, Canada
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
St. Mary's Hospital
Montreal, Quebec, Canada
Aichi cancer center hospital
Nagoya, Aichi-ken, Japan
Hyogo Cancer Center
Akashi, Hyōgo, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan
National Cancer Center Hospital
Chuo-Ku, Tokyo, Japan
Regionalny Osrodek Onkologiczny Wojewodzki Szpital Specjalistyczny im. M. Kopernika
Lodz, , Poland
Zaklad Radiologii
Lodz, , Poland
Centrum Onkologii Ziemi Lubelskiej im. Św. Jana z Dukli
Lublin, , Poland
Federal State Healthcare Institution
Lermontov, Stavropol Territory, Russia
Clinical Oncology Dispensary 1 of Department of Healthcare of the Krasnodar Region
Krasnodar, , Russia
Pyatigorsk Oncology Center
Pyatigorsk, , Russia
Saint Petersburg State Healthcare Institution City Clinical Oncology Dispensary
Saint Petersburg, , Russia
Hospital Universitari Vall d'hebron
Barcelona, , Spain
Centro Oncologico MD Anderson Internacional España
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Fundacion Instituto Valenciano de Oncologia - I.V.O.
Valencia, , Spain
Fundacion Instituto Valenciano de Oncologia - I.V.O
Valencia, , Spain
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
Beatson Oncology Centre
Glasgow, , United Kingdom
University College London Hospital NHS Foundation Trust
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
Countries
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References
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Del Campo JM, Birrer M, Davis C, Fujiwara K, Gollerkeri A, Gore M, Houk B, Lau S, Poveda A, Gonzalez-Martin A, Muller C, Muro K, Pierce K, Suzuki M, Vermette J, Oza A. A randomized phase II non-comparative study of PF-04691502 and gedatolisib (PF-05212384) in patients with recurrent endometrial cancer. Gynecol Oncol. 2016 Jul;142(1):62-69. doi: 10.1016/j.ygyno.2016.04.019. Epub 2016 Apr 24.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2011-003062-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B1271004
Identifier Type: -
Identifier Source: org_study_id
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