NRG-GY008, A Phase II Evaluation of Copanlisib (BAY 80-6946) (IND #130822), A Selective Inhibitor of PI3KCA, in Patients with Persistent or Recurrent Endometrial Carcinoma Harboring PIK3CA Hotspot Mutations
- Clements University Hospital
David Miller, M.D.
This is a single arm, two-stage, phase ii study, multicenter, and no randomization is involved however mutation screening is required.
Pi3CKa testing is being done to see if the patient has a mutation in her tumor Dna. a mutation is a change in the Dna. if the patient has this mutation, she will be eligible to participate in a clinical trial that looks at how people with this tumor mutation respond to the experimental study drug, copanlisib, after the usual treatment for endometrial cancer.
every patient who is considering joining the nRG-GY008 study will have a tumor sample tested at Q2 Solutions. Testing all the tumor samples at Q2 Solutions will also make sure that the Pi3CKa testing was done in the same way for everyone. The study doctor will be given the results of the Pi3KCa testing within 2 weeks (range 7-14 days) after Q2 Solutions receives the tumor sample. This information will be shared with the patient. if the test shows that the tumor has a Pi3KCa mutation, and the patient meets all other study requirements, the patient can join the nRG-GY008 study. The patient will need to sign another consent form that explains the nRG-GY008 treatment study. if the test shows that the tumor does not have a Pi3KCa mutation, patient will not be able to take part in the nRG-GY008 study and the doctor will discuss other treatment options with the patient.
Screening for Main Consent:
The patient will need to have the following extra tests to find out if the patient can be in the study:
* Left Ventricular ejection Fraction (LVeF) test to see how the heart is working and make sure it is safe for the patient to receive the study drug
During the study:
* The patient will have her blood pressure monitored several times before, during and after each copanlisib infusion. For cycle one the patient will be monitored about 3 hours after the infusion.
* The patient will have her blood sugar monitored several times before and after the first two copanlisib infusions, and more often if necessary. The patient will need to stay in the clinic a few extra hours on these days. The patient may be asked to take blood sugar measurements at home and record them in a diary to share with the doctor.
* The patient will have an additional Left Ventricular ejection Fraction (LVeF) test to see how the heart is working at the end of the treatment when the patient is no longer taking the study drug.
a sample from the tissue that was collected at the time of the surgery or biopsy will be used for this study. This sample is required in order for the patient to take part in this study because the research on the sample is an important part of the study. The sample collected will be used to look at gene changes in the tumor.
any of the tissue sample that was collected at the time of the surgery or biopsy and that is left-over after completion of this research may be submitted to be stored for biobanking. This will be discussed in the section on optional studies.