Study Reactivation

To: All Principal Investigators, Co-Principal Investigators, Nurses and Clinical Data Coordinators

From: NRG Oncology Protocol NRG-GY012 Study team


Re:  NRG-
GY012: A Randomized Phase II Study comparing Single-Agent Olaparib, Single-Agent Cediranib and the Combination of Cediranib/Olaparib in Women with Recurrent, Persistent or Metastatic Endometrial Cancer  REACTIVATION


Date: April 8, 2019

 

Protocol NRG-GY012 was temporarily closed in order to perform a planned safety analysis. The analysis should have been conducted earlier as stated in the trial. When we realized the non-compliance issue, we immediately suspended the trial pending the analysis. The findings were reviewed by the NCI Central IRB and there were no safety concerns identified that preclude continuation of the trial. 

 

At the direction of the NCI Central IRB, letters were distributed to investigators who had treated patients on the trial and letters were provided to the investigators to disseminate to their patients explaining the non-compliance. The letters were submitted to CTEP and the NCI Central CIRB.

 

Having met the stipulations of the NCI Central IRB we are now re-opening the trial to new patient accrual effective April 8, 2019.

 

This memo will be available on CTSU within 24 hours

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