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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

August 17, 2011
November 17, 2014
October 2011
April 2014   (final data collection date for primary outcome measure)
Number of Participants With Clinical Benefit Response (CBR) [ Time Frame: 16 ] [ Designated as safety issue: No ]
CR+PR+SD 16 weeks
Clinical Benefit Rate [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01420081 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Objective tumor response rate, as assessed using RECIST [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Progression free survival rate at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Area under the plasma concentration versus time curve (AUC) of PF-04691502 [ 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 plasma concentration versus time curve (AUC) of PF-05212384 [ 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 ]
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Endometrial Neoplasms
Drug: PF-05212384
154mg IV weekly
Other Name: PKI-587
  • Experimental: B
    PI3K Basal, IV Compound
    Intervention: Drug: PF-05212384
  • Experimental: C
    PI3K Activated, Oral Compound
    Intervention: Drug: PF-05212384
  • Experimental: F
    Japanese lead in cohort, IV compound
    Intervention: Drug: PF-05212384
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
67
June 2015
April 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Japan,   Poland,   Russian Federation,   Spain,   United Kingdom
 
NCT01420081
B1271004, 2011-003062-32
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP