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This trial is a multicenter, prospective, phase II single arm, open-label trial in which patients with newly diagnosed advanced epithelial ovarian, primitive peritoneal, and fallopian tube cancer BRCA wild type, in partial or complete response to first line platinum-based chemotherapy, receive Olaparib maintenance therapy (300 mg, tablets formulation twice daily).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OLAPARIB | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olaparib Oral Product | Drug | Olaparib Maintenace Treatment after first line platium based chemotherapy in BRCA wilde-type ovarian cancer patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS). | PFS as defined by the Investigator using RECIST 1.1 as the time frame from enrollment to progression or death for any cause. | From date of enrollment until the date of first documentated progression or date of death from any cause, whichever came first, assessed up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival 2 (PFS2) | PFS2 as defined by the Investigator using RECIST 1.1, as the time frame from enrollment to the second progression or death for any cause after subsequent treatment. | From date of enrollment until the date of second documentated progression or date of death from any cause, whichever came first, assessed up to 60 months |
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Inclusion Criteria:
Signed informed consent obtained prior to initiation of any study-specific procedures.
Female aged≥18 years old on day of signing informed consent.
Patients with histologically diagnosed advanced stage III-IV according International Federation of Gynaecology and Obstetrics (FIGO), high grade serous or endometrioid, epithelial ovarian cancer (including primary peritoneal or fallopian tube cancer).
Patients with a complete or partial response to first line platinum-based treatment not including Bevacizumab.
Documented absence of somatic and germline mutations of BRCA 1 /2.
Patients must have a life expectancy ≥ 16 weeks.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1, (See Appendix A).
Availability of sufficient formalin-fixed paraffin-embedded (FFPE) tumor tissue from the primary surgery (chemotherapy - naïve patients) for translational analysis. A quality control analysis of samples will be performed before patient's enrollment.
Patients must be enrolled within 8 weeks of the first day of the last dose of chemotherapy.
Patients must be able to take oral medications.
Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on Day 1 Cycle 1.
Postmenopausal is defined as:
Women Women of childbearing potential and their partners, who are sexually active, must agree to the use of one highly effective forms of contraception and their partners must use a male condom (as described in Appendix D). This should be started from the signing of the informed consent and continue throughout the period of taking study treatment and for at least 1 month after last dose of study drug
Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
Haemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days; Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Platelet count ≥ 100 x 109/L; Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be ≤ 5x ULN
Patients must have creatinine clearance estimated of ≥51 mL/min using the Cockcroft-Gault equation or based on a 24-hour urine test:
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clorinda Schettino, MD | Contact | +3908159031791 | c.schettino@istitutotumori.na.it | |
| Sandro Pignata, MD | Contact | 390815903637 | s.pignata@istitutotumori.na.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ONCOLOGIA MEDICA A.O. S. Giuseppe Moscati | Not yet recruiting | Avellino | Italy |
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| Label | URL |
|---|---|
| Sponsor web-site for study conduction | View source |
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| Overall Survival | OS is defined as the time elapsed from randomization to death due to any cause | 5 years |
| Number of participants with treatment-related side effects graded according to Common Criteria for Adverse Events (CTCAE) version 5.0 | Number of participants with treatment-related side effects graded according to Common Criteria for Adverse Events (CTCAE) version 5.0 | At baseline,at end of each cycle (each cycle is 28 days) until progression disease or treatment discontinuation (up to 24 months)] |
| U.O.C. Oncologia Medica - Ospedale Senatore Antonio Perrino | Not yet recruiting | Brindisi | Italy |
|
| IRCCS Istituto Nazionale Tumori di Napoli | Recruiting | Naples | 80131 | Italy |
|
| Oncologia Medica 2 - Istituto Nazionale Tumori "Regina Elena" | Not yet recruiting | Roma | Italy |
|
| ONCOLOGIA MEDICA 1 Istituto Nazionale Tumori Regina Elena - IRCCS - IFO | Not yet recruiting | Rome | Italy |
|
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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