Study Reference |
Study Design |
Single Arm or Comparator |
Combination or Mon Therapy? |
Country or International |
Clinical Trial Number |
Ethical Approval |
Fong, 2009 |
Phase 1non-randomiseddose finding trial |
Single arm |
monotherapy |
UK (Royal Marsden) and Netherlands (Cancer Institute) |
NCT00516373 |
Non mentioned |
Tutt, 2010 |
Phase 2Non-randomisedProof of conceptSequential cohort |
Comparator arm on lower dose (100mg) |
Monotherapy |
Multinational - 26 centres across Australia, Germany, Spain, Sweden, UK and USA. |
NCT00494234 |
Written informed consentStudy approved by independent ethics committee for each trial centres, done in accordance with good clinical practice guidelines and Declaration of Helsinki |
Gelmon, 2011 |
Phase 2Non-randomisedOpen-label |
Single arm but can compares results between BRCAm or BRCAwt |
monotherapy |
6 centres across Canada. |
NCT00679783 |
Written informed consent. Study protocol approved by health Canada and institutional review boards and the six particiapating sites. |
Balmana, 2014 |
Phase 1`Non-randomisedDose finding trial |
Single arm |
Combination therapy (olaparib with cisplatin) |
Multi centre - country not stated but Balmana works out of University Hospital in Barcelona. |
NCT00782574 |
Study carried out in accordance with declaration of Helsinki, good clinical practice and AZ policy on bioethics. |
Kaufman, 2015 |
Phase 2Non-randomised |
Single arm but can compare different cancer types (ovarian, breast, pancreas, prostate and other) |
monotherapy |
Multinational - 13 centres across Israel, Australia, Germany, Spain, Sweden and USA |
NCT01078662 |
Written informed consent.Study carried out in accordance with international conference on harmonisation good clinical practice guidelines and declaration of Helsinki and approved by an independent ethics committee or institutional review board at every trial centre. |
Van der Noll, 2015 |
Long-term monotherapy safety study, following a phase 1 combination study |
Single arm but can compare different cancer types (breast, ovarian and fallopian tube). |
Monotherapy long-term safety study following a Phase 1 combination study (olaparib with carboplatin and/or paclitaxel). |
Netherlands Cancer Institute |
n/a |
No mention of ethical approval |
Robson, 2017 |
Phase 3RandomisedOpen-label |
Comparator arm was standard single chemotherapy of physicians choice (capecitabine, eribulin, or vinorelbine) |
monotherapy |
International - multi centres across 19 countries (Bulgaria, China, Czech Republic, France, Hungary, Italy, Japan, Korea, Mexico, Peru, Poland, Romania, Russia, Spain, Switzerland, Taiwan, Turkey, UK and USA.. |
NCT02000622 |
Protocol approved by ethics written informed consent. review committees at participating institutions |