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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 is currently recruiting participants.
Verified June 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01420081
First received: August 17, 2011
Last updated: June 4, 2013
Last verified: June 2013
History of Changes
  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:

U.S. FDA Resources

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 ]

Secondary Outcome Measures:
  • Number of Participants With Objective Response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: 12.0 ] [ Designated as safety issue: No ]
  • Progression-Free Survival (PFS) [ Time Frame: 12 ] [ Designated as safety issue: No ]
  • Progression-Free Survival (PFS) [ Time Frame: 6 ] [ Designated as safety issue: No ]
  • 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 ]
  • 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 ]
  • 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 ]

Estimated Enrollment: 144
Study Start Date: January 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 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

  Eligibility

Ages Eligible for Study:   20 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01420081

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 53 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01420081     History of Changes
Other Study ID Numbers: B1271004
Study First Received: August 17, 2011
Last Updated: June 4, 2013
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:
Uterine Neoplasms
Neoplasms
Endometrial Neoplasms
Adenoma
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on June 18, 2013