Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Long-Term Responders on Olaparib (OLALA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02489058
Recruitment Status : Recruiting
First Posted : July 2, 2015
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.


Condition or disease
Epithelial Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer

Detailed 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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: A Retrospective/Prospective Analysis of Characterization of the Long-Term Responders on Olaparib in Solid Tumours
Actual Study Start Date : February 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019





Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

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)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Epithelial ovarian cancer (including fallopian tube or peritoneal cancer) patients that are or had received treatment with Olaparib.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02489058


Contacts
Layout table for location contacts
Contact: Amit M. Oza, M.D. 416-946-2818

Locations
Layout table for location information
Canada, British Columbia
British Columbia Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Frances Topp, RN    604-877-6000 ext 2637      
Principal Investigator: Anna Tinker, M.D.         
Canada, Ontario
Ottawa Hospital Research Institute Not yet recruiting
Ottawa, Ontario, Canada
Contact: Johanne Weberpals, M.D.    613-737-7700 ext 76462      
Principal Investigator: Johanne Weberpals, M.D.         
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Amit Oza, M.D.    416-946-2818      
Principal Investigator: Amit Oza, M.D.         
Italy
Institute of European Oncology Not yet recruiting
Milan, Italy
Contact: Nicoletta Colombo, M.D.         
Principal Investigator: Nicoletta Colombo, M.D.         
Spain
Vall d'Hebron Not yet recruiting
Barcelona, Spain
Contact: Nuria Collantes    (+34)93 274 6000 ext 4691      
Principal Investigator: Ana Oaknin, M.D.         
United Kingdom
Edinburgh Cancer Research Centre Recruiting
Edinburgh, Scotland, United Kingdom
Contact: Charlie Gourley, M.D.    0131 537 3053      
Principal Investigator: Charlie Gourley         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Layout table for investigator information
Principal Investigator: Amit Oza, M.D. Princess Margaret Cancer Centre

Layout table for additonal information
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02489058     History of Changes
Other Study ID Numbers: OZM-061
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Layout table for MeSH terms
Fallopian Tube Neoplasms
Carcinoma, Ovarian Epithelial
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Ovarian Neoplasms
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders
Olaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents