Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer

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

Start Date

September 30, 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

January 2021