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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The goal of this prospective, phase IV, multi-centre clinical trial is to to define the proportion of patients with advanced high grade epithelial ovarian cancer (EOC) HRD-positive who will be treated at first line with olaparib in combination with bevacizumab as maintenance and to describe their clinical and demographic characteristics. Other primary objective is to confirm, in a setting close to clinical practice, the efficacy of olaparib concomitant with bevacizumab as maintenance treatment after first-line chemotherapy in patients with advanced high grade EOC HRD-positive and who have received bevacizumab in combination with chemotherapy.
This phase IV study will include two translational research projects:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olaparib - Bevacizumab | Other | Olaparib 300 mg 2*daily + Bevacizumab 15mg/kg (q3w) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olaparib | Drug | Olaparib is considered the study treatment. Olaparib tablets will be taken at the dose of 300 mg (2 x 150 mg tablet) twice daily adding to bevacizumab at a dose of 15 mg per kilogram of body weight every 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients treated with olaparib | Define the proportion of patients with advanced high grade epithelial ovarian cancer (EOC) HRD-positive who will be treated at first line with olaparib in combination with bevacizumab as maintenance and to describe their clinical and demographic characteristics | 42 months |
| Efficacy of olaparib | Confirm, in a setting close to clinical practice, the efficacy of olaparib concomitant with bevacizumab as maintenance treatment after first-line chemotherapy in patients with advanced high grade EOC HRD-positive and who have received bevacizumab in combination with chemotherapy. The efficacy will be evaluated in terms of PFS rate at 24 months. PFS will be defined as the time from the start of olaparib therapy until disease progression or death whichever comes first | 42 months |
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Inclusion Criteria:
8. Patients must have a life expectancy ≥ 16 weeks. 9. Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of olaparib administration and confirmed the day of treatment start.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Federica Tomao | Università degli Studi di Roma "La Sapienza", Viale del Policlinico 155, Roma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Socio Sanitaria Territoriale (ASST) Lariana | San Fermo della Battaglia | Como | 22042 | Italy | ||
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|
| Bevacizumab | Drug | Bevacizumab will be taken at a dose of 15 mg per kilogram of body weight every 3 weeks |
|
| Spedali Civili |
| Brescia |
| Italy |
| Policlinico Careggi | Florence | Italy |
| Ospedale Manzoni | Lecco | Italy |
| Ospedale San Luca | Lucca | Italy |
| Istituto Europeo di Oncologia | Milan | Italy |
| Istituto Nazionale dei Tumori | Milan | Italy |
| Istituto Oncologico Veneto IRCCS | Padova | 35128 | Italy |
| AOU Parma | Parma | Italy |
| Ospedale Santa Chiara | Pisa | Italy |
| Arcispedale Santa Maria Nuova | Reggio Emilia | Italy |
| Ospedale Umberto I | Roma | Italy |
| A.O. Ordine Mauriziano | Torino | Italy |
| A.O.U. Citta della Salute e della Scienza | Torino | Italy |
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| 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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| ID | Term |
|---|---|
| C531550 | olaparib |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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