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

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-19

Study Completion Date

2015-12-25

Brief Summary

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

Detailed Description

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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.

Conditions

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Endometrial Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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B

PI3K Basal, IV Compound

Group Type EXPERIMENTAL

PF-05212384

Intervention Type DRUG

154mg IV weekly

C

PI3K Activated, Oral Compound

Group Type EXPERIMENTAL

PF-05212384

Intervention Type DRUG

154mg IV weekly

F

Japanese lead in cohort, IV compound

Group Type EXPERIMENTAL

PF-05212384

Intervention Type DRUG

154mg IV weekly

Interventions

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PF-05212384

154mg IV weekly

Intervention Type DRUG

PF-05212384

154mg IV weekly

Intervention Type DRUG

PF-05212384

154mg IV weekly

Intervention Type DRUG

Other Intervention Names

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PKI-587 PKI-587 PKI-587

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

University of Alabama at Birmingham, IDS Pharmacy

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of California Medical Center

La Jolla, California, United States

Site Status

Moores UC San Diego Cancer Center

La Jolla, California, United States

Site Status

University of California Medical Center

San Diego, California, United States

Site Status

Mercy Hospital

Miami, Florida, United States

Site Status

Mercy Research Institute

Miami, Florida, United States

Site Status

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

University of Chicago Medicine Comprehensive Cancer Center at Silver Cross Hospital

New Lenox, Illinois, United States

Site Status

University of Kansas

Fairway, Kansas, United States

Site Status

University of Kansas Hospital

Kansas City, Kansas, United States

Site Status

University of Kansas Cancer Center and Medical Pavilion

Westwood, Kansas, United States

Site Status

Mary Bird Perkins Cancer Center at St. Tammany Parish Hospital

Covington, Louisiana, United States

Site Status

Women's Cancer Care

Covington, Louisiana, United States

Site Status

Women's Cancer Care

Metairie, Louisiana, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status

Peter MacCallum Cancer Centre, Division of Cancer Madicine

East Melbourne, Victoria, Australia

Site Status

Foothills Medical Center

Calgary, Alberta, Canada

Site Status

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Site Status

British Columbia Cancer Agency - Vancouver Centre

Vancouver, British Columbia, Canada

Site Status

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, Canada

Site Status

Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Royal Victoria Hospital

Montreal, Quebec, Canada

Site Status

Jewish General Hospital

Montreal, Quebec, Canada

Site Status

St. Mary's Hospital

Montreal, Quebec, Canada

Site Status

Aichi cancer center hospital

Nagoya, Aichi-ken, Japan

Site Status

Hyogo Cancer Center

Akashi, Hyōgo, Japan

Site Status

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Site Status

National Cancer Center Hospital

Chuo-Ku, Tokyo, Japan

Site Status

Regionalny Osrodek Onkologiczny Wojewodzki Szpital Specjalistyczny im. M. Kopernika

Lodz, , Poland

Site Status

Zaklad Radiologii

Lodz, , Poland

Site Status

Centrum Onkologii Ziemi Lubelskiej im. Św. Jana z Dukli

Lublin, , Poland

Site Status

Federal State Healthcare Institution

Lermontov, Stavropol Territory, Russia

Site Status

Clinical Oncology Dispensary 1 of Department of Healthcare of the Krasnodar Region

Krasnodar, , Russia

Site Status

Pyatigorsk Oncology Center

Pyatigorsk, , Russia

Site Status

Saint Petersburg State Healthcare Institution City Clinical Oncology Dispensary

Saint Petersburg, , Russia

Site Status

Hospital Universitari Vall d'hebron

Barcelona, , Spain

Site Status

Centro Oncologico MD Anderson Internacional España

Madrid, , Spain

Site Status

Hospital Clinico San Carlos

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Fundacion Instituto Valenciano de Oncologia - I.V.O.

Valencia, , Spain

Site Status

Fundacion Instituto Valenciano de Oncologia - I.V.O

Valencia, , Spain

Site Status

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

Site Status

Beatson Oncology Centre

Glasgow, , United Kingdom

Site Status

University College London Hospital NHS Foundation Trust

London, , United Kingdom

Site Status

The Royal Marsden NHS Foundation Trust

London, , United Kingdom

Site Status

Countries

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United States Australia Canada Japan Poland Russia Spain United Kingdom

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.

Reference Type DERIVED
PMID: 27103175 (View on PubMed)

Related Links

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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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