A Study Of PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer
Phase 2
Terminated
- Conditions
- Endometrial Neoplasms
- Registration Number
- JPRN-jRCT2080221700
- Lead Sponsor
- Pfizer Japan Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- terminated
- Sex
- Female
- Target Recruitment
- 252
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 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Clinical Benefit Rate (CBR)<br>To assess 16 weeks for CBR
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>- Objective Response Rate (ORR)<br>- Overall Survival (OS)<br>- Progression Free Survival (PFS)<br>- PFS at 6 months<br>- Pharmacokinetics (PK)<br>To assess 12 months for ORR, OS, PFS, and 6 months for PFS and PK