Clinical trial · Observational
A Study of Long-Term Responders on Olaparib
A Retrospective/Prospective Analysis of Characterization of the Long-Term Responders on Olaparib in Solid Tumours
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- The number of patients with somatic BRCA mutations compared to number of patients without somatic BRCA mutations
- timeFrame
- 4 years
- measure
- The number of patients with homologous recombination repair deficiencies compared to the number of patients that do not have homologous recombination repair deficiencies.
- timeFrame
- 4 years
- measure
- The number and types of mutated genes.
- timeFrame
- 4 years
- measure
- The number of patients with antibodies to the study drug
- timeFrame
- 4 years
- measure
- Evaluate the levels of PI3K/Akt pathway expression per patient
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available