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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

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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01420081