A Study of Long-Term Responders on Olaparib

NCT02489058 | Completed

• 1 other identifier: OZM-061
• Study Type: observational
• Target: 118
• Locations: 5 countries
• Sites: 8

Brief 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.

Conditions

Epithelial Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (4)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Epithelial ovarian cancer (including fallopian tube or peritoneal cancer) patients that are or had received treatment with Olaparib.

You may qualify if:

• 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.

You may not qualify if:

• Any severe acute or chronic medical or psychiatric condition or laboratory abnormality that would render the patient unsuitable for biopsy
• Pregnant or breastfeeding women

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (8)

South Eastern Sydney Local Health District

Randwick, New South Wales, 2031, Australia

Location

British Columbia Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Institute of European Oncology

Milan, Italy

Location

Vall d'Hebron

Barcelona, Spain

Location

The Royal Marsden

Sutton, England, SM2 5PT, United Kingdom

Location

Edinburgh Cancer Research Centre

Edinburgh, Scotland, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

* 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)

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Study Officials

• Amit Oza, M.D.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2015
• First Posted: July 2, 2015
• Study Start: February 1, 2016
• Primary Completion: June 16, 2021
• Study Completion: August 31, 2022
• Last Updated: January 10, 2023

Record last verified: 2023-01

Locations

CA (3); GB (2); IT (1); AU (1); ES (1)