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A Study Of PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer

A Randomized Phase 2 Non-Comparative Study Of The Efficacy Of PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer(B1271004)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221700
Enrollment
252
Registered
2012-01-24
Start date
2012-01-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Neoplasms

Interventions

investigational material(s) Generic name etc : PF-04691502 INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational mate

Sponsors

Pfizer Japan Inc.
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
efficacy Clinical Benefit Rate (CBR) To assess 16 weeks for CBR

Secondary

MeasureTime frame
safety efficacy pharmacokinetics - Objective Response Rate (ORR) - Overall Survival (OS) - Progression Free Survival (PFS) - PFS at 6 months - Pharmacokinetics (PK) To assess 12 months for ORR, OS, PFS, and 6 months for PFS and PK

Countries

Europe, Japan, North America, Oceania

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026