Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer
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| ClinicalTrials.gov Identifier: NCT04546373 |
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Recruitment Status :
Completed
First Posted : September 14, 2020
Last Update Posted : August 5, 2021
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In April 2017, Tesaro, Inc. opened an expanded access program (EAP) to make niraparib, an investigational poly (ADP-ribose) polymerase (PARP) inhibitor, available to eligible women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer following a complete or partial response to platinum-based chemotherapy, mainly for BRCA wild-type (BRCAwt) tumor patients, a clear unmet medical need for these ovarian cancer patients. As of 19 August 2019, the EAP closing date, there were 446 patients enrolled in 105 Spanish sites.
All eligible deceased and consenting living patients at the participating centers will be included. Data will be directly retrieved from hospital medical records and reported in the electronic Case Report Form (eCRF).
This study seeks to evaluate the safety profile and dose adjustments of niraparib in platinum sensitive recurrent ovarian cancer patients treated in a real world setting within the Spanish expanded access program (EAP).
| Condition or disease | Intervention/treatment |
|---|---|
| Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer | Drug: Niraparib |
| Study Type : | Observational |
| Actual Enrollment : | 316 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Retrospective |
| Official Title: | A Retrospective, Multicenter Study of Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer Who Have Received Niraparib Within the Expanded Access Program (EAP) in Spain |
| Actual Study Start Date : | September 30, 2020 |
| Actual Primary Completion Date : | July 31, 2021 |
| Actual Study Completion Date : | July 31, 2021 |
- Drug: Niraparib
Patient's medical records will be screened by local clinical staff to assess for eligibility according to selection criteria. The study comprises a single study visit, in which the patient will give her informed consent to participate (when the patient is alive) and the physician will extract the study data from the patient's medical charts. All eligible deceased and consenting living patients at the participating centers will be included. Data will be directly retrieved from hospital medical records and reported in the electronic Case Report Form (eCRF).
- Demographics [ Time Frame: Month 4-6 ]
- Medical History [ Time Frame: Month 4-6 ]
- Ovarian Cancer Diagnosis [ Time Frame: Month 4-6 ]
- Ovarian Cancer Treatments (pre-Niraparib) [ Time Frame: Month 4-6 ]
- Baseline (pre-Niraparib) [ Time Frame: Month 4-6 ]
- Niraparib Treatment [ Time Frame: Month 4-6 ]
- Niraparib Disease Progression [ Time Frame: Month 4-6 ]
- Best Response Assessment [ Time Frame: Month 4-6 ]
- Niraparib-Related Adverse Events [ Time Frame: Month 4-6 ]
- Relevant Concomitant Medications [ Time Frame: Month 4-6 ]
- Death [ Time Frame: Month 4-6 ]
- Survival Status [ Time Frame: Month 4-6 ]
- Subsequent Therapies for Ovarian Cancer [ Time Frame: Month 4-6 ]
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Female participants 18 years old or older.
- Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent.
- Participant must have received niraparib within the Spanish expanded access program (EAP).
- Patients must have received at least 1 week of treatment with niraparib.
- Histological diagnosis of high grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
- Participants must have completed at least 2 previous courses of platinum-containing therapy (e.g., carboplatin, oxaliplatin, or cisplatin).
- For the penultimate (next to last) platinum-based chemotherapy course prior to enrolment on the program the patient must have platinum sensitive disease after this treatment; defined as achieving a response (complete response (CR) or partial response (PR)) and disease progression occurring no sooner than 6 months, after completion of the last dose of platinum chemotherapy.
- For the last chemotherapy course prior to inclusion in the program the patient must have received a platinum-containing regimen for a minimum of 4 cycles.
- For the last chemotherapy course prior to inclusion in the program the Patient must have achieved a partial (PR) or complete (CR) tumor response.
- The last platinum regimen does not necessarily have to immediately follow the next to last (penultimate) platinum regimen. For example, if a patient received a non-platinum regimen between the penultimate platinum regimen and last platinum regimen, they could be eligible, so long as they meet all entry criteria.
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When entering the EAP, patients must have met the following:
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Adequate organ function - Absolute neutrophil count (ANC) ≥ (greater than or equal to) 1,500/μL.
- Adequate organ function - Platelets ≥ (greater than or equal to) 100,000/μL.
- Adequate organ function - Hemoglobin ≥ (greater than or equal to) 9 g/dL.
- No transfusions of erythrocytes or platelets within 2 weeks prior to assessing adequate hematological blood counts as listed above.
Exclusion Criteria:
- Patients without medical record available (lost, empty or unretrievable clinical information).
- Patients who decline consent.
- Patients who are deceased with prior express order to preserve their data.
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): NCT04546373
Show 57 study locations
| Principal Investigator: | Juan F. Cueva Bañuelos, Dr. | Complejo Hospitalario Universitario de Santiago de Compostela |
| Responsible Party: | Grupo Español de Investigación en Cáncer de Ovario |
| ClinicalTrials.gov Identifier: | NCT04546373 |
| Other Study ID Numbers: |
GEICO 88-R |
| First Posted: | September 14, 2020 Key Record Dates |
| Last Update Posted: | August 5, 2021 |
| Last Verified: | August 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Ovarian Neoplasms Carcinoma, Ovarian Epithelial Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases |
Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Fallopian Tube Diseases Niraparib Poly(ADP-ribose) Polymerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |