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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01420081




Registration number
NCT01420081
Ethics application status
Date submitted
17/08/2011
Date registered
19/08/2011
Date last updated
8/01/2019

Titles & IDs
Public title
A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer
Scientific title
A RANDOMIZED PHASE 2 NON-COMPARATIVE STUDY OF THE EFFICACY OF PF-04691502 AND PF-05212384 IN PATIENTS WITH RECURRENT ENDOMETRIAL CANCER
Secondary ID [1] 0 0
2011-003062-32
Secondary ID [2] 0 0
B1271004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-05212384
Treatment: Drugs - PF-05212384
Treatment: Drugs - PF-05212384

Experimental: B - PI3K Basal, IV Compound

Experimental: C - PI3K Activated, Oral Compound

Experimental: F - Japanese lead in cohort, IV compound


Treatment: Drugs: PF-05212384
154mg IV weekly

Treatment: Drugs: PF-05212384
154mg IV weekly

Treatment: Drugs: PF-05212384
154mg IV weekly
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical Benefit Response for PF-04691502
Timepoint [1] 0 0
16 weeks from Cycle 1 Day 1
Primary outcome [2] 0 0
Percentage of Participants With Clinical Benefit Response for PF-05212384
Timepoint [2] 0 0
16 weeks from Cycle 1 Day 1
Secondary outcome [1] 0 0
Objective Response for PF-04691502
Timepoint [1] 0 0
Randomization to objective progression, death or last tumor assessment without progression (up to 12 months)
Secondary outcome [2] 0 0
Percentage of Participants With Objective Response for PF-05212384
Timepoint [2] 0 0
Randomization to objective progression, death or last tumor assessment without progression (up to 12 months)
Secondary outcome [3] 0 0
Progression Free Survival for PF-04691502
Timepoint [3] 0 0
From Cycle 1 Day 1 to objective progressive disease or death due to any cause whichever occurs first (up to 12 months)
Secondary outcome [4] 0 0
Progression Free Survival for PF-05212384
Timepoint [4] 0 0
From Cycle 1 Day 1 to objective progressive disease or death due to any cause whichever occurs first (up to 12 months)
Secondary outcome [5] 0 0
Percentage of Participants With Progression Free Survival (PFS) at 6 Months for PF-05212384
Timepoint [5] 0 0
6 months
Secondary outcome [6] 0 0
Overall Survival (OS) for PF-05212384
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Level of Each Pharmacodynamic Parameter at Specified Timepoints- Glucose (mg/dL)
Timepoint [7] 0 0
Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days
Secondary outcome [8] 0 0
Level of Each Pharmacodynamic Parameter at Specified Timepoints- Insulin (UIU/mL)
Timepoint [8] 0 0
Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days
Secondary outcome [9] 0 0
Level of Each Pharmacodynamic Parameter at Specified Timepoints- Glycosylated Hemoglobin (HbA1c)
Timepoint [9] 0 0
Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days
Secondary outcome [10] 0 0
Level of Each Pharmacodynamic Parameter at Specified Timepoints- Cholesterol (mg/dL)
Timepoint [10] 0 0
Baseline (Day -3) and Cycle1 to Cycle 3 where each cycle consist of 28 days
Secondary outcome [11] 0 0
Level of Each Pharmacodynamic Parameter at Specified Timepoints- Triglycerides (mg/dL)
Timepoint [11] 0 0
Baseline (Day -3) and Cycle1 to Cycle 3 where each cycle consist of 28 days
Secondary outcome [12] 0 0
Stathmin H Score [Mean (SD)] for Each Treatment Arm With Gene and/or Protein Expression Biomarkers in Biopsied Tumor Tissue
Timepoint [12] 0 0
Prior to Cycle 1 Day 1
Secondary outcome [13] 0 0
Percentage of Participants in Each Treatment Arm With Gene and/or Protein Expression Biomarkers- PIK3CA Amplification, KRAS Mutation P/N, KRAS Mutation OBSV, PTEN Stroma Manual Score, PTEN Tumor Manual Score, KRAS SCC and Stathmin H/L,Tissue.
Timepoint [13] 0 0
Baseline and Cycle1 to Cycle 5 where each cycle consist of 28 days
Secondary outcome [14] 0 0
Area Under the Serum Concentration Time Profile From Time Zero Extrapolated to Infinity (AUCinf) of PF-05212384 at Each Specified Time Points.
Timepoint [14] 0 0
Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1
Secondary outcome [15] 0 0
Area Under the Serum Concentration Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-05212384 at Each Specified Time Points.
Timepoint [15] 0 0
Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1
Secondary outcome [16] 0 0
Maximum Plasma Concentration (Cmax) of PF-05212384 at Each Specified Time Points.
Timepoint [16] 0 0
Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1
Secondary outcome [17] 0 0
Terminal Elimination Half Life (t½) of PF-05212384 at Each Specified Time Points.
Timepoint [17] 0 0
Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1
Secondary outcome [18] 0 0
Time for Cmax (Tmax) of PF-05212384 at Each Specified Time Points.
Timepoint [18] 0 0
Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1
Secondary outcome [19] 0 0
Clearance (CL) of PF-05212384 at Each Specified Time Points.
Timepoint [19] 0 0
Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1
Secondary outcome [20] 0 0
Steady State Volume of Distribution (Vss) of PF-05212384 at Each Specified Time Points.
Timepoint [20] 0 0
Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours
Secondary outcome [21] 0 0
Number of Treatment-emergent Adverse Events (TEAEs) - All Causalities
Timepoint [21] 0 0
From baseline (-3 days) until 35 days post last dose
Secondary outcome [22] 0 0
Summary of Treatment-emergent Adverse Events (TEAEs) - All Causalities
Timepoint [22] 0 0
From baseline (-3 days) until 35 days post last dose
Secondary outcome [23] 0 0
Number of Treatment-related TEAEs
Timepoint [23] 0 0
From baseline (-3 days) until 35 days post last dose
Secondary outcome [24] 0 0
Summary of Treatment-related TEAEs
Timepoint [24] 0 0
From baseline (-3 days) until 35 days post last dose

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/12/2015
Sample size
Target
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre, Division of Cancer Madicine - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
New Mexico
Country [10] 0 0
Canada
State/province [10] 0 0
Alberta
Country [11] 0 0
Canada
State/province [11] 0 0
British Columbia
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
Japan
State/province [14] 0 0
Aichi
Country [15] 0 0
Japan
State/province [15] 0 0
Hyogo
Country [16] 0 0
Japan
State/province [16] 0 0
Saitama
Country [17] 0 0
Japan
State/province [17] 0 0
Tokyo
Country [18] 0 0
Poland
State/province [18] 0 0
Lodz
Country [19] 0 0
Poland
State/province [19] 0 0
Lublin
Country [20] 0 0
Russian Federation
State/province [20] 0 0
Stavropol Territory
Country [21] 0 0
Russian Federation
State/province [21] 0 0
Krasnodar
Country [22] 0 0
Russian Federation
State/province [22] 0 0
Pyatigorsk
Country [23] 0 0
Russian Federation
State/province [23] 0 0
Saint Petersburg
Country [24] 0 0
Spain
State/province [24] 0 0
Barcelona
Country [25] 0 0
Spain
State/province [25] 0 0
Madrid
Country [26] 0 0
Spain
State/province [26] 0 0
Valencia
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Surrey
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Glasgow
Country [29] 0 0
United Kingdom
State/province [29] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will investigate the individual safety and efficacy of two dual PI3K/mTOR inhibitors in patients with recurrent endometrial cancer.
Trial website
https://clinicaltrials.gov/study/NCT01420081
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01420081