Study Stopped
See termination reason in detailed description.
A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer
A RANDOMIZED PHASE 2 NON-COMPARATIVE STUDY OF THE EFFICACY OF PF-04691502 AND PF-05212384 IN PATIENTS WITH RECURRENT ENDOMETRIAL CANCER
2 other identifiers
interventional
67
8 countries
51
Brief Summary
This study will investigate the individual safety and efficacy of two dual PI3K/mTOR inhibitors in patients with recurrent endometrial cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2012
Typical duration for phase_2
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2011
CompletedFirst Posted
Study publicly available on registry
August 19, 2011
CompletedStudy Start
First participant enrolled
January 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2014
CompletedResults Posted
Study results publicly available
May 19, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 25, 2015
CompletedJanuary 8, 2019
December 1, 2018
2.3 years
August 17, 2011
April 30, 2015
December 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Clinical Benefit Response for PF-04691502
Clinical benefit response was defined as best overall response of complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks from Cycle 1 Day 1 (C1D1) to the first time of disease progression. The outcome data table below presents the number of participants with clinical benefit response as "yes" or "no". On 09 Oct 2012, Pfizer decided to stop enrollment into PF-04691502. While tumor assessment for PF-04691502 was included as a listing in the final report, formal efficacy analysis for PF-04691502 was not performed.
16 weeks from Cycle 1 Day 1
Percentage of Participants With Clinical Benefit Response for PF-05212384
Clinical benefit response was defined as best overall response of complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks from Cycle 1 Day 1 (C1D1) to the first time of disease progression. The primary analysis is based on the clinical benefit rate which is calculated as proportion of participants with a clinical benefit response relative to total number of response evaluable participants. Per RECIST v1.1 for target lesions: CR defined as disappearance of all target lesions; PR defined as \>=30% decrease in the sum of the longest diameter of target lesions; SD does not qualify for CR, PR or Progression. All target lesions must be assessed. SD can follow PR only in the rare case that the sum increases by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds. A Clopper-Pearson exact 95% CI for the clinical benefit rate is presented in the below table.
16 weeks from Cycle 1 Day 1
Secondary Outcomes (24)
Objective Response for PF-04691502
Randomization to objective progression, death or last tumor assessment without progression (up to 12 months)
Percentage of Participants With Objective Response for PF-05212384
Randomization to objective progression, death or last tumor assessment without progression (up to 12 months)
Progression Free Survival for PF-04691502
From Cycle 1 Day 1 to objective progressive disease or death due to any cause whichever occurs first (up to 12 months)
Progression Free Survival for PF-05212384
From Cycle 1 Day 1 to objective progressive disease or death due to any cause whichever occurs first (up to 12 months)
Percentage of Participants With Progression Free Survival (PFS) at 6 Months for PF-05212384
6 months
- +19 more secondary outcomes
Study Arms (3)
B
EXPERIMENTALPI3K Basal, IV Compound
C
EXPERIMENTALPI3K Activated, Oral Compound
F
EXPERIMENTALJapanese lead in cohort, IV compound
Interventions
Eligibility Criteria
You may qualify if:
- Recurrent endometrial carcinoma
- 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
You may not qualify if:
- More than 2 prior cytotoxic chemo regimens for endometrial carcinoma
- Prior therapy with an agent known to be a PI3K, and or mTOR and or AKT inhibitor
- Active brain metastases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (51)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham, IDS Pharmacy
Birmingham, Alabama, 35249, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
University of California Medical Center
La Jolla, California, 92037, United States
Moores UC San Diego Cancer Center
La Jolla, California, 92093, United States
University of California Medical Center
San Diego, California, 92103, United States
Mercy Hospital
Miami, Florida, 33133, United States
Mercy Research Institute
Miami, Florida, 33133, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
University of Chicago Medicine Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, 60451, United States
University of Kansas
Fairway, Kansas, 66205, United States
University of Kansas Hospital
Kansas City, Kansas, 66160, United States
University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas, 66205, United States
Mary Bird Perkins Cancer Center at St. Tammany Parish Hospital
Covington, Louisiana, 70433, United States
Women's Cancer Care
Covington, Louisiana, 70433, United States
Women's Cancer Care
Metairie, Louisiana, 70006, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Peter MacCallum Cancer Centre, Division of Cancer Madicine
East Melbourne, Victoria, 3002, Australia
Foothills Medical Center
Calgary, Alberta, T2N 2T9, Canada
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, K7L 5P9, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
St. Mary's Hospital
Montreal, Quebec, H3T 1M5, Canada
Aichi cancer center hospital
Nagoya, Aichi-ken, 464-8681, Japan
Hyogo Cancer Center
Akashi, Hyōgo, 673-8558, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298, Japan
National Cancer Center Hospital
Chuo-Ku, Tokyo, 104-0045, Japan
Regionalny Osrodek Onkologiczny Wojewodzki Szpital Specjalistyczny im. M. Kopernika
Lodz, 93-509, Poland
Zaklad Radiologii
Lodz, 93-513, Poland
Centrum Onkologii Ziemi Lubelskiej im. Św. Jana z Dukli
Lublin, 20-090, Poland
Federal State Healthcare Institution
Lermontov, Stavropol Territory, 357340, Russia
Clinical Oncology Dispensary 1 of Department of Healthcare of the Krasnodar Region
Krasnodar, 350040, Russia
Pyatigorsk Oncology Center
Pyatigorsk, 357502, Russia
Saint Petersburg State Healthcare Institution City Clinical Oncology Dispensary
Saint Petersburg, 198255, Russia
Hospital Universitari Vall d'hebron
Barcelona, 08035, Spain
Centro Oncologico MD Anderson Internacional España
Madrid, 28033, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Fundacion Instituto Valenciano de Oncologia - I.V.O.
Valencia, 46009, Spain
Fundacion Instituto Valenciano de Oncologia - I.V.O
Valencia, 46009, Spain
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT, United Kingdom
Beatson Oncology Centre
Glasgow, G12 0YN, United Kingdom
University College London Hospital NHS Foundation Trust
London, NW1 2PG, United Kingdom
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ, United Kingdom
Related Publications (1)
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.
PMID: 27103175DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2011
First Posted
August 19, 2011
Study Start
January 19, 2012
Primary Completion
April 30, 2014
Study Completion
December 25, 2015
Last Updated
January 8, 2019
Results First Posted
May 19, 2015
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.