A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

Official Title

A Phase II, Open-Label, Randomized, Multi-Centre Study, of Neoadjuvant Olaparib in Patients With Platinum Sensitive Recurrent High Grade Serous Ovarian/Primary Peritoneal or Fallopian Tube Cancer

Summary:

This is a study that will look at the effects and how useful investigational drug olaparib is as a neoadjuvant treatment (treatment given as to shrink a tumour before the main treatment) prior to surgery in patients with recurrent ovarian, primary peritoneal or fallopian tube cancer.

Trial Description

Primary Outcome:

• Difference in levels of PAR or PARP-1 before and after study treatment
• Mutations in BRCA1/2, RAD51B, RAD51C, RAD51D, PPM1D, FANCM, BRIP1, PALB2 and BARD1 in germline tissue compared to tumour tissue

Secondary Outcome:

• Frequency of adverse events, by description and grade
• Response rate to olaparib in the neoadjuvant period
• Duration of progression free survival with olaparib in comparison to platinum based chemotherapy
• Levels of ctDNA compared to levels of CA125
• Gene expression changes in tumour tissue before and after treatment with Olaparib
• Secondary mutation rate in surgical tumour specimens following PARP therapy and at progression
• Changes in blood based biomarkers using ctDNA before, during and after treatment with Olaparib

Olaparib belongs to a class of anti-cancer agents known as poly ADP-ribose polymerase (PARP) inhibitors. Olaparib is a new type of drug for ovarian cancer. Laboratory tests show that it may help slow the growth of ovarian cancer. Olaparib works by blocking the PARP protein. PARP is an important protein which tries to fix damaged deoxyribonucleic acid (DNA, molecules that contain important instructions for the development of cells). Many cancers are thought to develop from damaged DNA. Research has shown that PARP inhibitors stop the PARP protein from working, and that sometimes that can cause cancer cells to stop growing or die.

View this trial on ClinicalTrials.gov