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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
A RANDOMIZED PHASE 2 NON-COMPARATIVE STUDY OF THE EFFICACY OF PF-04691502 AND PF-05212384 IN PATIENTS WITH RECURRENT ENDOMETRIAL CANCER
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Secondary ID [1]
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2011-003062-32
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Secondary ID [2]
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B1271004
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Endometrial Neoplasms
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0
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Condition category
Condition code
Cancer
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Womb (Uterine or endometrial cancer)
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Clinical Benefit Response for PF-04691502
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Assessment method [1]
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Clinical benefit response was defined as best overall response of complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks from Cycle 1 Day 1 (C1D1) to the first time of disease progression. The outcome data table below presents the number of participants with clinical benefit response as "yes" or "no". On 09 Oct 2012, Pfizer decided to stop enrollment into PF-04691502. While tumor assessment for PF-04691502 was included as a listing in the final report, formal efficacy analysis for PF-04691502 was not performed.
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Timepoint [1]
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16 weeks from Cycle 1 Day 1
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Primary outcome [2]
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Percentage of Participants With Clinical Benefit Response for PF-05212384
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Assessment method [2]
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Clinical benefit response was defined as best overall response of complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks from Cycle 1 Day 1 (C1D1) to the first time of disease progression. The primary analysis is based on the clinical benefit rate which is calculated as proportion of participants with a clinical benefit response relative to total number of response evaluable participants. Per RECIST v1.1 for target lesions: CR defined as disappearance of all target lesions; PR defined as >=30% decrease in the sum of the longest diameter of target lesions; SD does not qualify for CR, PR or Progression. All target lesions must be assessed. SD can follow PR only in the rare case that the sum increases by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds. A Clopper-Pearson exact 95% CI for the clinical benefit rate is presented in the below table.
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Timepoint [2]
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16 weeks from Cycle 1 Day 1
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Secondary outcome [1]
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Objective Response for PF-04691502
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Assessment method [1]
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Objective response is defined as CR or PR. CR: Complete response: 2 or more objective statuses of CR a minimum of 4 weeks apart documented before PD. Partial response: 2 or more objective statuses of PR or better a minimum of 4 weeks apart documented before PD, but not qualifying as CR. Per RECIST v1.1 for target lesions: CR defined as disappearance of all target lesions; PR defined as >=30% decrease in the sum of the longest diameter of target lesions. The outcome data table below presents the number of participants with objective response as "yes" or "no". On 09 Oct 2012, Pfizer decided to stop enrollment into PF-04691502. While tumor assessment for PF-04691502 was included as a listing in the final report, formal efficacy analysis for PF-04691502 was not performed.
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Timepoint [1]
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Randomization to objective progression, death or last tumor assessment without progression (up to 12 months)
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Secondary outcome [2]
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Percentage of Participants With Objective Response for PF-05212384
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Assessment method [2]
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Objective response is defined as CR or PR. CR: Complete response: 2 or more objective statuses of CR a minimum of 4 weeks apart documented before PD. Partial response: 2 or more objective statuses of PR or better a minimum of 4 weeks apart documented before PD, but not qualifying as CR. Per RECIST v1.1 for target lesions: CR defined as disappearance of all target lesions; PR defined as >=30% decrease in the sum of the longest diameter of target lesions.
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Timepoint [2]
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Randomization to objective progression, death or last tumor assessment without progression (up to 12 months)
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Secondary outcome [3]
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Progression Free Survival for PF-04691502
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Assessment method [3]
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PFS is defined as the time from the date of cycle 1 day 1 to the date that objective progressive disease is documented or death due to any cause, whichever occurs first. PFS was characterized in terms of the median. Approximate 95% confidence interval corresponding to this estimate was computed. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions with a minimum absolute increase of 5 mm, or an unequivocal progression of non-target lesion, or the appearance of new lesions. On 09 Oct 2012, Pfizer decided to stop enrollment into PF-04691502. While tumor assessment for PF-04691502 was included as a listing in the final report, formal efficacy analysis for PF-04691502 was not performed.
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Timepoint [3]
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From Cycle 1 Day 1 to objective progressive disease or death due to any cause whichever occurs first (up to 12 months)
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Secondary outcome [4]
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Progression Free Survival for PF-05212384
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Assessment method [4]
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PFS is defined as the time from the date of cycle 1 day 1 to the date that objective progressive disease is documented or death due to any cause, whichever occurs first. PFS was characterized in terms of the median. Approximate 95% confidence interval corresponding to this estimate was computed. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions with a minimum absolute increase of 5 mm, or an unequivocal progression of non-target lesion, or the appearance of new lesions.
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Timepoint [4]
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From Cycle 1 Day 1 to objective progressive disease or death due to any cause whichever occurs first (up to 12 months)
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Secondary outcome [5]
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Percentage of Participants With Progression Free Survival (PFS) at 6 Months for PF-05212384
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Assessment method [5]
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Progression free survival is defined as the time from the date of cycle 1 day 1 to the date that objective progressive disease is documented or death due to any cause, whichever occurs first. PFS was characterized in terms of the probability of remaining progression-free at 6 months (based on Kaplan-Meier estimates). Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions with a minimum absolute increase of 5 mm, or an unequivocal progression of non-target lesion, or the appearance of new lesions.
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Timepoint [5]
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6 months
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Secondary outcome [6]
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Overall Survival (OS) for PF-05212384
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Assessment method [6]
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OS is defined as the time from the date of Cycle 1 Day 1 to the date of death.
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Timepoint [6]
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12 months
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Secondary outcome [7]
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Level of Each Pharmacodynamic Parameter at Specified Timepoints- Glucose (mg/dL)
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Assessment method [7]
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PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.
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Timepoint [7]
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Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days
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Secondary outcome [8]
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Level of Each Pharmacodynamic Parameter at Specified Timepoints- Insulin (UIU/mL)
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Assessment method [8]
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PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.
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Timepoint [8]
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Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days
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Secondary outcome [9]
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Level of Each Pharmacodynamic Parameter at Specified Timepoints- Glycosylated Hemoglobin (HbA1c)
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Assessment method [9]
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PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.
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Timepoint [9]
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Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days
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Secondary outcome [10]
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Level of Each Pharmacodynamic Parameter at Specified Timepoints- Cholesterol (mg/dL)
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Assessment method [10]
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PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.
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Timepoint [10]
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Baseline (Day -3) and Cycle1 to Cycle 3 where each cycle consist of 28 days
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Secondary outcome [11]
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Level of Each Pharmacodynamic Parameter at Specified Timepoints- Triglycerides (mg/dL)
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Assessment method [11]
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PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.
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Timepoint [11]
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Baseline (Day -3) and Cycle1 to Cycle 3 where each cycle consist of 28 days
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Secondary outcome [12]
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Stathmin H Score [Mean (SD)] for Each Treatment Arm With Gene and/or Protein Expression Biomarkers in Biopsied Tumor Tissue
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Assessment method [12]
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Gene and/or protein expression biomarkers in biopsied tumor tissue relating to PI3K and/or mTOR pathway activation, such as PIK3CA and PIK3R1 mutations, PTEN protein levels, and PIK3CA gene amplification were to be assessed.
Each slide was imaged by whole slide scanning and patient samples were scored as follows:
Pathologist manual score (0, 1+, 2+, 3+) for overall staining intensity of tumor tissue.
Percentage of positive tumor cells staining at 0, 1+, 2+, and 3+.
H-score value (integer between 0 and 300) for tumor cell staining was calculated. The higher the stathmin staining, the higher the stathmin H-score.
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Timepoint [12]
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Prior to Cycle 1 Day 1
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Secondary outcome [13]
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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.
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Assessment method [13]
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Gene and/or protein expression biomarkers in biopsied tumor tissue relating to PI3K and/or mTOR pathway activation, such as PIK3CA and PIK3R1 mutations, Phosphatase And Tensin Homolog (PTEN) protein levels, and PIK3CA gene amplification were to be assessed.
Stained tissues were evaluated by a board-certified pathologist who provided a manual pathology score (i.e., 0, 1+, 2+, or 3+) and, if appropriate, comments upon the staining of the specimen.
The directionality increases from 0 to 3+ with 0 being no staining for PTEN by IHC and 3+ being high staining intensity for PTEN.
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Timepoint [13]
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Baseline and Cycle1 to Cycle 5 where each cycle consist of 28 days
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Secondary outcome [14]
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Area Under the Serum Concentration Time Profile From Time Zero Extrapolated to Infinity (AUCinf) of PF-05212384 at Each Specified Time Points.
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Assessment method [14]
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0
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Timepoint [14]
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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
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Secondary outcome [15]
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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.
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Assessment method [15]
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0
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Timepoint [15]
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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
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Secondary outcome [16]
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Maximum Plasma Concentration (Cmax) of PF-05212384 at Each Specified Time Points.
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Assessment method [16]
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0
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Timepoint [16]
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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
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Secondary outcome [17]
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Terminal Elimination Half Life (t½) of PF-05212384 at Each Specified Time Points.
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Assessment method [17]
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Timepoint [17]
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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
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Secondary outcome [18]
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Time for Cmax (Tmax) of PF-05212384 at Each Specified Time Points.
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Assessment method [18]
0
0
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Timepoint [18]
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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
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Secondary outcome [19]
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Clearance (CL) of PF-05212384 at Each Specified Time Points.
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Assessment method [19]
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0
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Timepoint [19]
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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
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Secondary outcome [20]
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Steady State Volume of Distribution (Vss) of PF-05212384 at Each Specified Time Points.
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Assessment method [20]
0
0
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Timepoint [20]
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Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours
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Secondary outcome [21]
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Number of Treatment-emergent Adverse Events (TEAEs) - All Causalities
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Assessment method [21]
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Safety of participants in terms of TEAEs. Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm.
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Timepoint [21]
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From baseline (-3 days) until 35 days post last dose
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Secondary outcome [22]
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Summary of Treatment-emergent Adverse Events (TEAEs) - All Causalities
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Assessment method [22]
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Safety of participants in terms of TEAEs. Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm.
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Timepoint [22]
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From baseline (-3 days) until 35 days post last dose
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Secondary outcome [23]
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Number of Treatment-related TEAEs
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Assessment method [23]
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Safety of subject in terms of number of participants with treatment related AEs.
Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm.
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Timepoint [23]
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From baseline (-3 days) until 35 days post last dose
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Secondary outcome [24]
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Summary of Treatment-related TEAEs
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Assessment method [24]
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Safety of subject in terms of number of participants with treatment related AEs.
Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm.
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Timepoint [24]
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From baseline (-3 days) until 35 days post last dose
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/01/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
25/12/2015
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Sample size
Target
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Accrual to date
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Final
67
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peter MacCallum Cancer Centre, Division of Cancer Madicine - East Melbourne
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Recruitment postcode(s) [1]
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3002 - East Melbourne
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Illinois
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Kansas
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Louisiana
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Massachusetts
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Michigan
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Country [9]
0
0
United States of America
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State/province [9]
0
0
New Mexico
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Country [10]
0
0
Canada
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State/province [10]
0
0
Alberta
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Country [11]
0
0
Canada
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State/province [11]
0
0
British Columbia
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Country [12]
0
0
Canada
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State/province [12]
0
0
Ontario
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Country [13]
0
0
Canada
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State/province [13]
0
0
Quebec
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Country [14]
0
0
Japan
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State/province [14]
0
0
Aichi
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Country [15]
0
0
Japan
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State/province [15]
0
0
Hyogo
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Country [16]
0
0
Japan
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State/province [16]
0
0
Saitama
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Country [17]
0
0
Japan
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State/province [17]
0
0
Tokyo
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Country [18]
0
0
Poland
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State/province [18]
0
0
Lodz
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Country [19]
0
0
Poland
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State/province [19]
0
0
Lublin
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Country [20]
0
0
Russian Federation
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State/province [20]
0
0
Stavropol Territory
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Country [21]
0
0
Russian Federation
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State/province [21]
0
0
Krasnodar
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Country [22]
0
0
Russian Federation
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State/province [22]
0
0
Pyatigorsk
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Country [23]
0
0
Russian Federation
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State/province [23]
0
0
Saint Petersburg
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Country [24]
0
0
Spain
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State/province [24]
0
0
Barcelona
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Country [25]
0
0
Spain
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State/province [25]
0
0
Madrid
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Country [26]
0
0
Spain
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State/province [26]
0
0
Valencia
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Country [27]
0
0
United Kingdom
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State/province [27]
0
0
Surrey
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Country [28]
0
0
United Kingdom
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State/province [28]
0
0
Glasgow
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Country [29]
0
0
United Kingdom
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State/province [29]
0
0
London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will investigate the individual safety and efficacy of two dual PI3K/mTOR
inhibitors in patients with recurrent endometrial cancer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01420081
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Pfizer CT.gov Call Center
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Address
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0
Pfizer
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
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0
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Fax
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0
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Email
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0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01420081
Download to PDF