A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (NEO)
|Ovarian Cancer Fallopian Tube Cancer Neoadjuvant Treatment Debulking Surgical Procedures||Drug: Olaparib Drug: Platinum-based Chemotherapy||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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 ]
|Study Start Date:||July 2016|
|Estimated Study Completion Date:||June 2019|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
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: LynparzaDrug: 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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02489006
|Contact: Amit Oza, M.D.||416-946-2818|
|Tom Baker Cancer Centre||Not yet recruiting|
|Calgary, Alberta, Canada, T2N 4N2|
|Contact: Prafull Ghatage, M.D. 403-521-3721|
|Principal Investigator: Prafull Ghatage, M.D.|
|Juravinski Cancer Centre||Not yet recruiting|
|Hamilton, Ontario, Canada, L8V 5C2|
|Contact: Holger (Hal) Hirte, M.D. (905) 387-9495|
|Principal Investigator: Holger (Hal) Hirte, M.D.|
|London Regional Cancer Centre||Not yet recruiting|
|London, Ontario, Canada, N6A 4L6|
|Contact: Stephen Welch, M.D. 416-685-8640|
|Ottawa Regional Cancer Centre||Not yet recruiting|
|Ottawa, Ontario, Canada, K1H 8L6|
|Contact: Johanne Weberpals, M.D. 519-737-8899 ext. 76462|
|Principal Investigator: Johanne Weberpals, M.D.|
|Hôpital Notre-Dame||Not yet recruiting|
|Montréal, Quebec, Canada, H2L 4M1|
|Contact: Diane Provencher, M.D. 514-890-8000 ext 27244|
|Principal Investigator: Diane Provencher, M.D.|
|Principal Investigator:||Amit Oza, M.D.||Princess Margaret Cancer Centre/University Health Network|