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A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer

NCT01420081TerminatedPHASE2INTERVENTIONAL

Summary

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

Key Facts

Lead Sponsor

Pfizer

Enrollment

Start Date

2012-01-19

Completion Date

2014-04-30

Study Type

INTERVENTIONAL

Official Title

A RANDOMIZED PHASE 2 NON-COMPARATIVE STUDY OF THE EFFICACY OF PF-04691502 AND PF-05212384 IN PATIENTS WITH RECURRENT ENDOMETRIAL CANCER

Interventions

PF-05212384PF-05212384PF-05212384

Conditions

Endometrial Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Clinical Benefit Response for PF-04691502

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.

Time frame: 16 weeks from Cycle 1 Day 1

Percentage of Participants With Clinical Benefit Response for PF-05212384

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.

Time frame: 16 weeks from Cycle 1 Day 1

Secondary Outcomes

Objective Response for PF-04691502

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.

Time frame: Randomization to objective progression, death or last tumor assessment without progression (up to 12 months)

Percentage of Participants With Objective Response for PF-05212384

Time frame: Randomization to objective progression, death or last tumor assessment without progression (up to 12 months)

Progression Free Survival for PF-04691502

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.

Time frame: From Cycle 1 Day 1 to objective progressive disease or death due to any cause whichever occurs first (up to 12 months)

Progression Free Survival for PF-05212384

Time frame: From Cycle 1 Day 1 to objective progressive disease or death due to any cause whichever occurs first (up to 12 months)

Percentage of Participants With Progression Free Survival (PFS) at 6 Months for PF-05212384

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.

Time frame: 6 months

Overall Survival (OS) for PF-05212384

OS is defined as the time from the date of Cycle 1 Day 1 to the date of death.

Time frame: 12 months

Level of Each Pharmacodynamic Parameter at Specified Timepoints- Glucose (mg/dL)

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.

Time frame: Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days

Level of Each Pharmacodynamic Parameter at Specified Timepoints- Insulin (UIU/mL)

Time frame: Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days

Level of Each Pharmacodynamic Parameter at Specified Timepoints- Glycosylated Hemoglobin (HbA1c)

Time frame: Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days

Level of Each Pharmacodynamic Parameter at Specified Timepoints- Cholesterol (mg/dL)

Time frame: Baseline (Day -3) and Cycle1 to Cycle 3 where each cycle consist of 28 days

Level of Each Pharmacodynamic Parameter at Specified Timepoints- Triglycerides (mg/dL)

Time frame: Baseline (Day -3) and Cycle1 to Cycle 3 where each cycle consist of 28 days

Stathmin H Score [Mean (SD)] for Each Treatment Arm With Gene and/or Protein Expression Biomarkers in Biopsied Tumor Tissue

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.

Time frame: Prior to Cycle 1 Day 1

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.

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.

Time frame: Baseline and Cycle1 to Cycle 5 where each cycle consist of 28 days

Area Under the Serum Concentration Time Profile From Time Zero Extrapolated to Infinity (AUCinf) of PF-05212384 at Each Specified Time Points.