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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Endometrial Neoplasms

Treatments: Drug: PF-05212384

Study type: Interventional

Funder types: Industry

Identifiers

NCT01420081

B1271004

2011-003062-32 (EudraCT Number)

Details and patient eligibility

About

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

Full description

The study was prematurely discontinued due to lack confidence in the Stathmin assay as a patient selection criteria and subsequent lack of confidence in the efficacy signal that was observed. The decision to terminate the study was made on January 23, 2014. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Enrollment: 67 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

67 participants in 3 patient groups

B

Experimental group

Description:

PI3K Basal, IV Compound

Treatment:

Drug: PF-05212384

Drug: PF-05212384

Drug: PF-05212384

C

Experimental group

Description:

PI3K Activated, Oral Compound

Treatment:

Drug: PF-05212384

Drug: PF-05212384

Drug: PF-05212384

F

Experimental group

Description:

Japanese lead in cohort, IV compound

Treatment:

Drug: PF-05212384

Drug: PF-05212384

Drug: PF-05212384