A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (NEO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02489006|
Recruitment Status : Active, not recruiting
First Posted : July 2, 2015
Last Update Posted : May 16, 2022
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Fallopian Tube Cancer Neoadjuvant Treatment Debulking Surgical Procedures||Drug: Olaparib Drug: Platinum-based Chemotherapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||July 19, 2016|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2024|
Experimental: Olaparib Prior to Surgery, Chemotherapy/Olaparib Post Surgery
Olaparib, orally, at 300 mg twice per day, for 6 weeks (+/- 2 weeks) prior to surgery.
Platinum-based chemotherapy chosen by the study doctor and per standard of care after surgery.
Olaparib, orally, at 300 mg twice per day, continuously, after chemotherapy.
Other Name: Lynparza
Drug: Platinum-based Chemotherapy
Chosen by the study doctor, per standard of care.
Experimental: Olaparib Prior to Surgery and Post Surgery
Olaparib, orally, at 300 mg twice per day, for 6 weeks (+/- 2 weeks) prior to surgery and after surgery.
Other Name: Lynparza
- Difference in levels of PAR or PARP-1 before and after study treatment [ Time Frame: 4-8 weeks ]
- Mutations in BRCA1/2, RAD51B, RAD51C, RAD51D, PPM1D, FANCM, BRIP1, PALB2 and BARD1 in germline tissue compared to tumor tissue [ Time Frame: 2.5 years ]
- Frequency of adverse events, by description and grade [ Time Frame: 2.5 years ]
- Response rate to olaparib in the neoadjuvant period [ Time Frame: 6 weeks ]
- Duration of progression free survival with olaparib in comparison to platinum based chemotherapy [ Time Frame: 2.5 years ]
- Levels of ctDNA compared to levels of CA125 [ Time Frame: 2.5 years ]
- Gene expression changes in tumour tissue before and after treatment with Olaparib [ Time Frame: 2.5 years ]
- Secondary mutation rate in surgical tumour specimens following PARP therapy and at progression [ Time Frame: 2.5 years ]2.5 years
- Changes in blood based biomarkers using ctDNA before, during and after treatment with Olaparib [ Time Frame: 2.5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02489006
|Tom Baker Cancer Centre|
|Calgary, Alberta, Canada, T2N 4N2|
|Ottawa Regional Cancer Centre|
|Ottawa, Ontario, Canada, K1H 8L6|
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G 2M9|
|Centre hospitalier de l'Université de Montréal (CHUM|
|Montréal, Quebec, Canada, H2L 2W5|
|Jewish General Hospital|
|Montréal, Quebec, Canada, H3T 1E2|
|Auckland City Hospital|
|Grafton, Auckland, New Zealand|
|Vall d'Hebron University Hospital|
|Barcelona, Spain, 08035|
|Royal Marsden Hospital NHS Foundation Trust|
|London, United Kingdom, SW3 6JJ|
|Imperial College Healthcare NHS Trust|
|London, United Kingdom|
|Principal Investigator:||Amit Oza, M.D.||Princess Margaret Cancer Centre/University Health Network|