Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 tumor before the main treatment) prior to surgery in patients with recurrent ovarian, primary peritoneal or fallopian tube cancer.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olaparib Prior to Surgery, Chemotherapy/Olaparib Post Surgery | Experimental | 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. |
|
| Olaparib Prior to Surgery and Post Surgery | Experimental | Olaparib, orally, at 300 mg twice per day, for 6 weeks (+/- 2 weeks) prior to surgery and after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olaparib | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in levels of PAR or PARP-1 before and after study treatment | 4-8 weeks | |
| Mutations in BRCA1/2, RAD51B, RAD51C, RAD51D, PPM1D, FANCM, BRIP1, PALB2 and BARD1 in germline tissue compared to tumor tissue | 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events, by description and grade | 2.5 years | |
| Response rate to olaparib in the neoadjuvant period | 6 weeks | |
| Duration of progression free survival with olaparib in comparison to platinum based chemotherapy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amit Oza, M.D. | Princess Margaret Cancer Centre/University Health Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tom Baker Cancer Centre | Calgary | Alberta | T2N 4N2 | Canada | ||
| Ottawa Regional Cancer Centre |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Platinum-based Chemotherapy | Drug | Chosen by the study doctor, per standard of care. |
|
| 2.5 years |
| Levels of ctDNA compared to levels of CA125 | 2.5 years |
| Gene expression changes in tumour tissue before and after treatment with Olaparib | 2.5 years |
| Secondary mutation rate in surgical tumour specimens following PARP therapy and at progression | 2.5 years | 2.5 years |
| Changes in blood based biomarkers using ctDNA before, during and after treatment with Olaparib | 2.5 years |
| Ottawa |
| Ontario |
| K1H 8L6 |
| Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| Centre hospitalier de l'Université de Montréal (CHUM | Montreal | Quebec | H2L 2W5 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Auckland City Hospital | Grafton | Auckland | New Zealand |
| Vall d'Hebron University Hospital | Barcelona | 08035 | Spain |
| Royal Marsden Hospital NHS Foundation Trust | London | SW3 6JJ | United Kingdom |
| Imperial College Healthcare NHS Trust | London | United Kingdom |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C531550 | olaparib |
| D017671 | Platinum Compounds |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
Not provided
Not provided