Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2026-01-07 @ 7:54 AM
Study NCT ID:
NCT02489058
Status:
COMPLETED
Last Update Posted:
2023-01-10
First Post:
2015-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Long-Term Responders on Olaparib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '* Archival tumor tissue sample for biomarker research\n* Optional fresh tumor tissue sample for biomarker research (if participants are still on olaparib and their disease progressed)\n* Blood sample for pharmacokinetics (if participants are still on olaparib)\n* Blood sample for pharmacogenomics (if participants are still on olaparib and their disease progressed)\n* Blood samples for circulating tumor DNA (if participants are still on olaparib)\n* Blood sample for germline BRCA1/2 testing if not previously done (if participants are still on olaparib and their disease progressed)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-08', 'studyFirstSubmitDate': '2015-04-24', 'studyFirstSubmitQcDate': '2015-07-01', 'lastUpdatePostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of patients with somatic BRCA mutations compared to number of patients without somatic BRCA mutations', 'timeFrame': '4 years'}, {'measure': 'The number of patients with homologous recombination repair deficiencies compared to the number of patients that do not have homologous recombination repair deficiencies.', 'timeFrame': '4 years'}, {'measure': 'The number and types of mutated genes.', 'timeFrame': '4 years'}, {'measure': 'The number of patients with antibodies to the study drug', 'timeFrame': '4 years'}, {'measure': 'Evaluate the levels of PI3K/Akt pathway expression per patient', 'timeFrame': '4 years'}], 'secondaryOutcomes': [{'measure': 'HRR deficiency profile', 'timeFrame': '4 years'}, {'measure': 'Level of poly (ADP-ribose) (PAR) expression', 'timeFrame': '4 years'}, {'measure': 'Signature of PARP response compared with signature of platinum sensitivity', 'timeFrame': '4 years'}, {'measure': 'Signature of PARP response and PARP resistance on different tumour sites', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Epithelial Ovarian Cancer', 'Fallopian Tube Cancer', 'Peritoneal Cancer']}, 'descriptionModule': {'briefSummary': 'This is an observational and sample collection study involving patients (alive or deceased) from several clinical trials who had received the investigational drug, olaparib in other research studies. There is no intervention given for this study.\n\nThis research is being done to understand of the mechanisms involved in patients whose cancer responds well and whose cancer does not respond well to investigational drug, olaparib, to help better understand how olaparib works and to better identify patients who may benefit from this therapy.', 'detailedDescription': "This is study will compare biomarker research with response in patients who have received olaparib.\n\nPatients who have had a durable response to olaparib for at least 2 years will be approached for the study.\n\nPatients who agree to this study will then have their medical history collected and will be asked to complete a questionnaire. Archival tumor tissue will also be collected for biomarker research.\n\nA waiver of consent is requested to access the medical records and archival tumor tissue of patients who are deceased.\n\nIf participants are still taking olaparib, they will be asked to provide blood samples for pharmacokinetics and circulating tumor DNA, and the results of CT scans taken as part of their standard of care or as a part of another research study. If participants' disease worsens while still on olaparib, they will then be asked to provide a blood sample for pharmacogenomics and BRCA testing (if not known). An optional tumor biopsy will also be requested.\n\nParticipants will continue to be followed by telephone for survival and any new treatments they are receiving."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Epithelial ovarian cancer (including fallopian tube or peritoneal cancer) patients that are or had received treatment with Olaparib.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Previous or current treatment with Olaparib in a clinical trial/standard of care that included one of the following as a first step study for epithelial ovarian cancer (including fallopian tube or peritoneal cancer):\n\n * single agent olaparib given for relapsed disease or\n * single agent olaparib given as maintenance therapy after response to platinum based chemotherapy or\n * olaparib combined with platinum based chemotherapy and then continued as maintenance therapy or\n * olaparib combined with other types of therapy\n* Had a durable response to Olaparib defined as patients who have benefited from olaparib for \\> 18 months. Patients who discontinued Olaparib due to toxicities but otherwise meet the definition of a durable response will be included or the control group is patients who had a short duration benefit with Olaparib of less than 6 months in any individual clinical trial/standard of care\n* Ability to understand and the willingness to sign a written informed consent document.\n* Patient's willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* Any severe acute or chronic medical or psychiatric condition or laboratory abnormality that would render the patient unsuitable for biopsy\n* Pregnant or breastfeeding women"}, 'identificationModule': {'nctId': 'NCT02489058', 'acronym': 'OLALA', 'briefTitle': 'A Study of Long-Term Responders on Olaparib', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'A Retrospective/Prospective Analysis of Characterization of the Long-Term Responders on Olaparib in Solid Tumours', 'orgStudyIdInfo': {'id': 'OZM-061'}}, 'contactsLocationsModule': {'locations': [{'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'South Eastern Sydney Local Health District', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Hospital Research Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Institute of European Oncology', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': "Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'The Royal Marsden', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Edinburgh Cancer Research Centre', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'Amit Oza, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Princess Margaret Cancer Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}