Gynecologic Cancer NRG GY008

Sponsor: NRG Oncology

Number: NRG-GY008

This phase II (Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety) trial studies how well Copanlisib works in treating patients with endometrial cancer that has not decreased or disappeared, and the cancer may still be in the body despite treatment (persistent) or has come back (recurrent). Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Who’s eligible: 

• Submission of tumor tissue is required for all patients.
• Patients must have recurrent or persistent endometrial cancer (endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma or adenocarcinoma not otherwise specified [NOS]); histologic (tissue microscopically examined) confirmation of the primary tumor is required.
• All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension.
• Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1. 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.
• This study is for women age 18 and older.

Available at:  The Hospital of Central Connecticut, Hartford Hospital.