Endometrial Neoplasms
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| efficacy Clinical Benefit Rate (CBR) To assess 16 weeks for CBR | — |
Secondary
| Measure | Time 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