Phase 2, PF-04691502 and PF-05212384 in recurrent endometrial cancer
Research type
Research Study
Full title
A Randomised Phase 2 Non-Comparative Study of the Efficacy of PF-04691502 and PF-05212384 in Patients with Recurrent Endometrial Cancer
IRAS ID
96965
Contact name
Martin Gore
Sponsor organisation
Pfizer Inc.
Eudract number
2011-003062-32
Clinicaltrials.gov Identifier
Research summary
Endometrial cancer arises from the endometrium or lining of the uterus (womb). The most common type is endometrial carcinoma, a cancer of the epithelium, the tissue that covers all cavities and surfaces of structures throughout the body. This typically occurs within a few decades of menopause and is associated with obesity and excessive oestrogen (the primary female sex hormone) exposure. Endometrial cancer presents with a wide variety of symptoms including vaginal bleeding and/or spotting in postmenopausal women; abnormal menstrual periods, anemia (decrease in the number of red blood cells) and lower abdominal pain. It is the most common gynaecological malignancy and most patients have good outcomes from initial treatment which can include surgery, radiotherapy, chemotherapy or a combination of these. Patients with recurrent endometrial cancer remain with a poor prognosis as no standard chemotherapy program is available. Targeted agents which are specifically designed to target molecular pathways are not yet indicated for endometrial cancer. Pfizer has developed the new PI3K/mTOR inhibitors PF-04691502 (oral) and PF-05212384 (intravenous) that work by inhibiting the PI3K pathway and the protein mTOR (mammalian Target Of Rapamycin) both of which are involved in cellular function such as cell growth. Pfizer is sponsoring a randomised, treatment allocated randomly, open label study as participants will know what treatments they receiving, to assess how effective and safe PF-04691502 and PF-05212384 are in adult patients with recurrent endometrial cancer for whom no standard therapy is available. Patients will be allocated to different arms depending on the pathway activation status: ?½ Arm A: PI3K Basal, PF-04691502 Oral ?½ Arm B: PI3K Basal, PF-05212384 IV ?½ Arm C: PI3K activated, PF-04691502 Oral ?½ Arm D: PI3K activated, PF-05212384 IV Approximately 14 countries will take part in the study. The countries involved in the study include Australia, Canada, France, Germany, Japan, Philippines, Poland, Russia, Slovakia, Spain, Taiwan, Turkey, the UK and the US. Between 80 and 252 women will be enrolled in the study.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
12/SC/0239
Date of REC Opinion
1 Jun 2012
REC opinion
Further Information Favourable Opinion