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NCT Number: NCT02489058

A Study of Long-Term Responders on Olaparib

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

South Eastern Sydney Local Health District, Randwick, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The number of patients with somatic BRCA mutations compared to number of patients without somatic BRCA mutations

    Time frame: 4 years

  2. The number of patients with homologous recombination repair deficiencies compared to the number of patients that do not have homologous recombination repair deficiencies.

    Time frame: 4 years

  3. The number and types of mutated genes.

    Time frame: 4 years

  4. The number of patients with antibodies to the study drug

    Time frame: 4 years

  5. Evaluate the levels of PI3K/Akt pathway expression per patient

    Time frame: 4 years

Secondary outcomes

  1. HRR deficiency profile

    Time frame: 4 years

  2. Level of poly (ADP-ribose) (PAR) expression

    Time frame: 4 years

  3. Signature of PARP response compared with signature of platinum sensitivity

    Time frame: 4 years

  4. Signature of PARP response and PARP resistance on different tumour sites

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: OLALA

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Jul 2, 2015
Registry last updated
Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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