Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02489058




Registration number
NCT02489058
Ethics application status
Date submitted
24/04/2015
Date registered
2/07/2015
Date last updated
10/01/2023

Titles & IDs
Public title
A Study of Long-Term Responders on Olaparib
Scientific title
A Retrospective/Prospective Analysis of Characterization of the Long-Term Responders on Olaparib in Solid Tumours
Secondary ID [1] 0 0
OZM-061
Universal Trial Number (UTN)
Trial acronym
OLALA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epithelial Ovarian Cancer 0 0
Fallopian Tube Cancer 0 0
Peritoneal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The number of patients with somatic BRCA mutations compared to number of patients without somatic BRCA mutations
Timepoint [1] 0 0
4 years
Primary outcome [2] 0 0
The number of patients with homologous recombination repair deficiencies compared to the number of patients that do not have homologous recombination repair deficiencies.
Timepoint [2] 0 0
4 years
Primary outcome [3] 0 0
The number and types of mutated genes.
Timepoint [3] 0 0
4 years
Primary outcome [4] 0 0
The number of patients with antibodies to the study drug
Timepoint [4] 0 0
4 years
Primary outcome [5] 0 0
Evaluate the levels of PI3K/Akt pathway expression per patient
Timepoint [5] 0 0
4 years
Secondary outcome [1] 0 0
HRR deficiency profile
Timepoint [1] 0 0
4 years
Secondary outcome [2] 0 0
Level of poly (ADP-ribose) (PAR) expression
Timepoint [2] 0 0
4 years
Secondary outcome [3] 0 0
Signature of PARP response compared with signature of platinum sensitivity
Timepoint [3] 0 0
4 years
Secondary outcome [4] 0 0
Signature of PARP response and PARP resistance on different tumour sites
Timepoint [4] 0 0
4 years

Eligibility
Key inclusion criteria
* 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):

* single agent olaparib given for relapsed disease or
* single agent olaparib given as maintenance therapy after response to platinum based chemotherapy or
* olaparib combined with platinum based chemotherapy and then continued as maintenance therapy or
* olaparib combined with other types of therapy
* 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
* Ability to understand and the willingness to sign a written informed consent document.
* Patient's willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any severe acute or chronic medical or psychiatric condition or laboratory abnormality that would render the patient unsuitable for biopsy
* Pregnant or breastfeeding women

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/08/2022
Sample size
Target
Accrual to date
Final
118
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
South Eastern Sydney Local Health District - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Italy
State/province [3] 0 0
Milan
Country [4] 0 0
Spain
State/province [4] 0 0
Barcelona
Country [5] 0 0
United Kingdom
State/province [5] 0 0
England
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Scotland

Funding & Sponsors
Primary sponsor type
Other
Name
University Health Network, Toronto
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amit Oza, M.D.
Address 0 0
Princess Margaret Cancer Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02489058