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A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01420081
First received: August 17, 2011
Last updated: November 17, 2014
Last verified: November 2014
  Purpose

This study will investigate the individual safety and efficacy of two dual PI3K/mTOR inhibitors in patients with recurrent endometrial cancer.


Condition Intervention Phase
Endometrial Neoplasms
Drug: PF-05212384
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase 2 Non-comparative Study Of The Efficacy Of Pf-04691502 And Pf-05212384 In Patients With Recurrent Endometrial Cancer

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Clinical Benefit Response (CBR) [ Time Frame: 16 ] [ Designated as safety issue: No ]
    CR+PR+SD 16 weeks


Secondary Outcome Measures:
  • Number of Participants With Objective Response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.

  • Overall Survival (OS) [ Time Frame: 12.0 ] [ Designated as safety issue: No ]
  • Progression-Free Survival (PFS) [ Time Frame: 12 ] [ Designated as safety issue: No ]
    Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (Weeks) = (first event date minus first dose date plus 1) divided by 7

  • Progression-Free Survival (PFS) [ Time Frame: 6 ] [ Designated as safety issue: No ]
    Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (Weeks) = (first event date minus first dose date plus 1) divided by 7

  • Area under the Concentration-Time Curve (AUC) [ Time Frame: Pre-dose, and post dose at 0.5, 1, 2, 3, 4, 6, and 24 hours post dose. Pre dose cycles 2, 3, 4 ] [ Designated as safety issue: No ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

  • Area under the Concentration-Time Curve (AUC) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 24, 72, and 120 hours post dose and pre and 0.5 hour post dose cycles 2, 3, 4 ] [ Designated as safety issue: No ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

  • Expression and/or phosphorylation in biopsied tumor tissue of PI3K pathway proteins [ Time Frame: Baseline and 28 days ] [ Designated as safety issue: No ]
  • Gene and/or protein expression biomarkers in biopsied tumor tissue relating to PI3K and/or mTOR pathway activation [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: October 2011
Estimated Study Completion Date: June 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: B
PI3K Basal, IV Compound
Drug: PF-05212384
154mg IV weekly
Other Name: PKI-587
Experimental: C
PI3K Activated, Oral Compound
Drug: PF-05212384
154mg IV weekly
Other Name: PKI-587
Experimental: F
Japanese lead in cohort, IV compound
Drug: PF-05212384
154mg IV weekly
Other Name: PKI-587

Detailed Description:

The study was prematurely discontinued due to lack confidence in the Stathmin assay as a patient selection criteria and subsequent lack of confidence in the efficacy signal that was observed. The decision to terminate the study was made on January 23, 2014. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420081

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249-7333
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Drug Shipment Address: University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
United States, California
Moores UC San Diego Cancer Center
La Jolla, California, United States, 92093
University of California Medical Center
La Jolla, California, United States, 92037
University of California Medical Center
San Diego, California, United States, 92103
United States, Florida
Mercy Hospital
Miami, Florida, United States, 33133
Mercy Research Institute
Miami, Florida, United States, 33133
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
University of Chicago Medicine Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, United States, 60451
United States, Kansas
University of Kansas
Fairway, Kansas, United States, 66205
University of Kansas Hospital
Kansas City, Kansas, United States, 66160
University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas, United States, 66205
United States, Louisiana
Mary Bird Perkins Cancer Center at St. Tammany Parish Hospital
Covington, Louisiana, United States, 70433
Women's Cancer Care
Covington, Louisiana, United States, 70433
Women's Cancer Care
Metairie, Louisiana, United States, 70006
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute (Drug Shipment Only)
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Massachusetts General Hospital (Drug Shipment Only)
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Australia, Victoria
Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology
East Melbourne, Victoria, Australia, 3002
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Japan
Aichi cancer center central hospital / Medical Oncology
Nagoya, Aichi, Japan, 464-8681
Hyogo Cancer Center
Akashi, Hyogo, Japan, 673-8558
Saitama Medical University International Medical Center-Comprehensive Cancer Center
Hidaka, Saitama, Japan, 350-1298
National Cancer Center Hospital
Chuo-Ku, Tokyo, Japan, 104-0045
Poland
Regionalny Osrodek Onkologiczny Oddzial Brachyterapii
Lodz, Poland, 93-509
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
Lublin, Poland, 20-090
Russian Federation
Clinical Oncology Dispensary 1 of Department of Healthcare of the Krasnodar Region
Krasnodar, Russian Federation, 350040
Pyatigorsk Oncology Center
Pyatigorsk, Russian Federation, 35702
Saint Petersburg State Healthcare Institution City Clinical Oncology Dispensary
Saint Petersburg, Russian Federation, 198255
Spain
Hospital General Vall d'hebron
Barcelona, Spain, 08035
Centro Oncologico MD Anderson Internacional España
Madrid, Spain, 28033
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario San Carlos
Madrid, Spain, 28040
Fundacion Instituto Valenciano de Oncologia
Valencia, Spain, 46009
United Kingdom
Royal Marsden Hospital
London, England, United Kingdom, SW3 6JJ
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom
University College London Hospital NHS Foundation Trust
London, United Kingdom, NW1 2PG
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01420081     History of Changes
Other Study ID Numbers: B1271004, 2011-003062-32
Study First Received: August 17, 2011
Last Updated: November 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
uterine neoplasms
endometrial
uterine
cancer
PI3K
mTOR
PI3K/mTOR
recurrent
metastatic

Additional relevant MeSH terms:
Endometrial Neoplasms
Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Site
Urogenital Neoplasms
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014