Brief Title
Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer
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
Brief Summary
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).
Study Type
Observational
Primary Outcome
Demographics
Condition
Epithelial Ovarian Cancer
Intervention
Niraparib
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
370
Start Date
September 7, 2020
Completion Date
February 1, 2021
Primary Completion Date
February 1, 2021
Eligibility Criteria
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.
- 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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Juan F. Cueva Bañuelos, Dr., +34 971439900, [email protected]
Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT04546373
Organization ID
GEICO 88-R
Responsible Party
Sponsor
Study Sponsor
Grupo Español de Investigación en Cáncer de Ovario
Study Sponsor
Juan F. Cueva Bañuelos, Dr., Principal Investigator, Complejo Hospitalario Universitario de Santiago de Compostela
Verification Date
September 2020