Clinical trial that may be of interest to some of you

[GwenHP]

I received an email with information about a clinical trial that some of you might be interested in learning more about. Below is a cut and paste from that email:

TESARO is sponsoring the PRIMA clinical trial which is evaluating the efficacy of niraparib vs. placebo as maintenance therapy for women who have responded (CR or PR) to front-line platinum-based chemotherapy. The protocol has recently been amended as a result of new information about the safety and efficacy of niraparib in women with Ovarian Cancer. We want to be sure that you are kept in the loop regarding the work that we’re doing. After all, you and your constituents are our true Key Opinion Leaders.

The title of the trial has been changed to:

“A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy.”

This reflects a change in the study population which now allows for the inclusion of women who are HRD negative or undetermined. Stratification factors will include HRD status.

The updated inclusion and exclusion criteria as found on clinicaltrials.gov are listed below:

clinicaltrials.gov/ct2/show...

Main Inclusion Criteria

• Patient must have histologically confirmed, advanced (FIGO Stage III or IV) high-grade predominantly serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have completed first line platinum based chemotherapy (neoadjuvant or adjuvant)

• Patient must have clinical complete response or partial response following completion of chemotherapy course

• All Stage IV patients are eligible, irrespective of residual disease, after primary or interval debulking. Stage III patients are required to have visible residual disease after primary surgery. Patients with inoperable Stage III and IV disease are eligible

• Patient must agree to undergo tumor HRD testing

• Patients of childbearing potential must have negative pregnancy serum test within 72 hours of being dosed

• Patient must be randomized within 12 weeks of the first day of the last cycle of chemotherapy

Main Exclusion Criteria

• Patient has mucinous or clear cell subtypes of epithelial ovarian cancer, carcinosarcoma or undifferentiated ovarian cancer

• Patient has undergone more than 2 debulking surgeries

• Patient has received bevacizumab with first-line platinum based therapy

• Patient is pregnant, breastfeeding, or expecting to conceive children, while receiving study treatment and for 3 months after the last dose of study treatment

• Patient has had prior treatment with a known PARP inhibitor

• Patient has been diagnosed and/or treated for invasive cancer (other than ovarian cancer)

We recognize that it is challenging for people who want specific site information and it isn’t listed on CT.gov. My name and contact information are provided on the CT.gov page and I get calls/e-mails regularly. Be assured that I respond to all inquiries promptly.

Don’t hesitate to let me know if you, your colleagues or your constituents have any questions.

Warm regards,

-Beth

Beth Zaharoff

Director, Patient Focused Drug Development

TESARO, 1000 Winter St North, Ste 3300, Waltham, MA 02451

Direct: +1 781.209.5485| Mobile: [phone]| Fax: [phone]

[e-mail]

[Barbi1986]

Thank you Gwen for this information.

[miyoshi]

Zejua (niraparib made by TESARO) was just FDA-approved fda.gov/Drugs/InformationOn...

[missa13]

Thanks for this info!