A Study of Long-Term Responders on Olaparib

Fallopian Tube Cancer Clinical Trial

— OLALA  

Official title:

A Retrospective/Prospective Analysis of Characterization of the Long-Term Responders on Olaparib in Solid Tumours

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02489058
• Other study ID #: OZM-061
• Status: Completed
• Start date: February 2016
• Est. completion date: August 31, 2022

Study information

• Verified date: January 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

This is study will compare biomarker research with response in patients who have received olaparib.

Patients who have had a durable response to olaparib for at least 2 years will be approached for the study.

Patients 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.

A waiver of consent is requested to access the medical records and archival tumor tissue of patients who are deceased.

If 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.

Participants will continue to be followed by telephone for survival and any new treatments they are receiving.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: August 31, 2022
• Est. primary completion date: June 16, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Peritoneal Cancer

Locations

Country	Name	City	State
Australia	South Eastern Sydney Local Health District	Randwick	New South Wales
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	British Columbia Cancer Centre	Vancouver	British Columbia
Italy	Institute of European Oncology	Milan
Spain	Vall d'Hebron	Barcelona
United Kingdom	Edinburgh Cancer Research Centre	Edinburgh	Scotland
United Kingdom	The Royal Marsden	Sutton	England

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Countries where clinical trial is conducted

Australia,  Canada,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients with somatic BRCA mutations compared to number of patients without somatic BRCA mutations		4 years
Primary	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
Primary	The number and types of mutated genes.		4 years
Primary	The number of patients with antibodies to the study drug		4 years
Primary	Evaluate the levels of PI3K/Akt pathway expression per patient		4 years
Secondary	HRR deficiency profile		4 years
Secondary	Level of poly (ADP-ribose) (PAR) expression		4 years
Secondary	Signature of PARP response compared with signature of platinum sensitivity		4 years
Secondary	Signature of PARP response and PARP resistance on different tumour sites		4 years