A Study of Long-Term Responders on Olaparib
OLALA
A Retrospective/Prospective Analysis of Characterization of the Long-Term Responders on Olaparib in Solid Tumours
OLALA
A Retrospective/Prospective Analysis of Characterization of the Long-Term Responders on Olaparib in Solid Tumours
Sponsor study identifier
observational
118
5 countries
8
Study Start
February 2016
Actual (reported)Primary Completion
June 16, 2021
Actual (reported)Study Completion
August 31, 2022
Actual (reported)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. This 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 24, 2015
Actual (reported)July 2, 2015
Actual (reported)February 2016
Actual (reported)June 16, 2021
Actual (reported)August 31, 2022
Actual (reported)The number of patients with somatic BRCA mutations compared to number of patients without somatic BRCA mutations
4 years
The number of patients with homologous recombination repair deficiencies compared to the number of patients that do not have homologous recombination repair deficiencies.
4 years
The number and types of mutated genes.
4 years
The number of patients with antibodies to the study drug
4 years
Evaluate the levels of PI3K/Akt pathway expression per patient
4 years
HRR deficiency profile
4 years
Level of poly (ADP-ribose) (PAR) expression
4 years
Signature of PARP response compared with signature of platinum sensitivity
4 years
Signature of PARP response and PARP resistance on different tumour sites
4 years
Epithelial ovarian cancer (including fallopian tube or peritoneal cancer) patients that are or had received treatment with Olaparib.
South Eastern Sydney Local Health District
Randwick, New South Wales, 2031, Australia
British Columbia Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Institute of European Oncology
Milan, Italy
Vall d'Hebron
Barcelona, Spain
The Royal Marsden
Sutton, England, SM2 5PT, United Kingdom
* Archival tumor tissue sample for biomarker research * Optional fresh tumor tissue sample for biomarker research (if participants are still on olaparib and their disease progressed) * Blood sample for pharmacokinetics (if participants are still on olaparib) * Blood sample for pharmacogenomics (if participants are still on olaparib and their disease progressed) * Blood samples for circulating tumor DNA (if participants are still on olaparib) * Blood sample for germline BRCA1/2 testing if not previously done (if participants are still on olaparib and their disease progressed)
Amit Oza, M.D.
Princess Margaret Cancer Centre
118 participants (actual enrollment reported by the registry).
First Submitted
April 24, 2015
First Posted
July 2, 2015
Study Start
February 2016
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
Edinburgh Cancer Research Centre
Edinburgh, Scotland, United Kingdom
June 16, 2021
Actual (reported)Study Completion
August 31, 2022
Actual (reported)Last Updated
January 10, 2023
Record last verified: 2023-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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