Study ID: NRG GY012
A randomized phase II study comparing single-agent olaparib, single-agent cediranib, and the combination of dediranib/olaparib in women with recurrent, persistent or metastatic endometrial cancer
Researchers seek to determine the safety and efficacy of a treatment regimen for patients whose endometrial cancer has returned, does not respond to treatment or has spread to other parts of her body. Participants are randomized into three treatment groups.
- Arm 1: cediranib maleate, which is a drug that may help keep cancer cells from growing by affecting their blood supply
- Arm 2: Lynparza® (olaparib), an FDA-approved targeted therapy for cancer and currently being prescribed for patients diagnosed with recurrent ovarian or breast cancer
- Arm 3: both of those drugs
Patients must have had one prior chemotherapy for management of endometrial carcinoma, but not have received chemotherapy for recurrent or persistent disease. Prior hormonal therapy is permitted.
Additionally, participants must have adequately controlled blood pressure and be willing and able to record their daily blood pressure readings.
This is a randomized, phase II study comparing olaparib, cediranib or a combination of the two in women with recurrent, persistent or metastatic endometrial cancer. The following histologic epithelial cell types are eligible:
- Endometrioid adenocarcinoma
- Serous adenocarcinoma
- Undifferentiated carcinoma
- Mixed epithelial carcinoma
- Adenocarcinoma not otherwise specified
Note: Clear cell histology is excluded.
- Arm 1: cediranib maleate
- Arm 2: olaparib
- Arm 3: cediranib maleate and olaparib
All courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Recurrent or persistent endometrial carcinoma (refractory to curative therapy)
- Must have evaluable disease as defined by RECIST 1.1 (see eligibility in protocol for complete details)
- Tumors within a previously irradiated field will be designated as “non-target” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
- Must have had one prior chemotherapeutic regimen for management of endometrial carcinoma
- Must have not received any non-cytotoxic chemotherapy for management of recurrent or persistent disease (prior hormonal therapy allowed)
- Patients must have adequately controlled blood pressure and be willing and able to check and record daily blood pressure readings