EUCTR2020-005101-12-DE进行中（未招募）1 期
Window-of-opportunity proof-of-concept, non-randomized, open-label phase II trial of Olaparib given alone (cohort A) or in combination with Durvalumab (cohort B) prior to primary debulking surgery in histologically proven high-grade epithelial ovarian cancer (EOC) - WoO: Window of Opportunity trial of Olaparib and Durvalumab in histo-logically proven EOC
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •WoO pre-treatment (screening phase):
- •1. Patients with presumed and previously untreated advanced stage ovarian cancer planned to undergo laparoscopy for histologic diagnosis and treatment planning
- •2. Patients willing and able to comply with the study protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
- •3. Patients able and willing to provide a fresh frozen biopsy from laparoscopy as well as primary debulking for translational endpoints as well as serial liquid biopsies
- •4. Patients able and willing to provide formaldehyde-fixed paraffin embedded (FFPE) tissue samples from laparoscopy and primary debulking surgery
- •5. Patients aged =18 years
- •6. Patients must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- •7. Provision of signed and dated, written ICF for the mandatory biomarker and genetic research as well as the clinical/therapeutic part of the study prior to any mandatory study specific procedures, sampling, and analyses
- •8. Eastern cooperative oncology group (ECOG) performance status 0-1
- •9. Patients must have a life expectancy =16 weeks
- •10. Ability to take oral medication
- •11. Postmenopausal or evidence of non-childbearing status for women of childbearing potential (WOCBP): negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1.
- •Postmenopausal is defined as:
- •- Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments
- •- Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50
- •- radiation-induced oophorectomy with last menses >1 year ago
- •- chemotherapy-induced menopause with >1 year interval since last menses
- •- surgical sterilisation (bilateral oophorectomy or hysterectomy)
- •12. Women of childbearing potential (WOCBP) and their partners, who are sexually active, must agree to the use of TWO highly effective forms of contraception in combination (as described in Appendix 5 of the CIP. This should be started from the signing of the informed consent and continue throughout the period of taking study treatment and for at least 90 days after last dose of study drug(s), or they must totally/truly abstain from any form of sexual intercourse (as described in Appendix 5 of the CIP).
- •WoO treatment phase:
- •13. Confirmed advanced (FIGO IIB/III/IV) high-grade, non-mucinous, non-clear cell epithelial ovarian, fallopian tube or primary peritoneal cancer or known BRCA mutation and any histologic type
- •14. Planned primary debulking surgery after confirmation of diagnosis and disease evaluation during laparoscopy
- •15. Body weight >30kg
- •16. 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) =1.5×109/L
- •- Platelet count =100×109/L
- •- Total bilirubin =1.5 × institutional upper limit of normal (ULN)
- •- Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) =2.5 × institutional upper limit of normal unless liver metastases are present in which case they must be =5×ULN. (Cave: patients with intrahepatic metastases affecting liver f
排除标准
- •1. Significant uncontrolled concomitant disease or illness that could affect compliance with the study protocol
- •3. Other malignancy unless curatively treated with no evidence of disease for =5 years except
- •4. Any unresolved toxicity NCI CTCAE Grade =2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- •5. Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML
- •6. Brain metastases or spinal cord compression, Evidence of central nervous system (CNS) or leptomeningeal metastases
- •8. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection
- •10. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
- •11. History of active primary immunodeficiency
- •12. ECOG performance status (PS) =2 or general condition that might interfere with the compliance with the study protocol
- •Prior / concomitant therapy
- •13. Prior antineoplastic therapy for ovarian, fallopian tube or primary peritoneal cancer
- •14. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment
- •15. Any concurrent chemotherapy, investigational product (IP), biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable
- •16. Patients planned for neoadjuvant chemotherapy or deemed unresectable at laparoscopy
- •17. Concomitant use of known strong CYP3A inhibitors
- •18. Concomitant use of known strong or moderate CYP3A inducers
- •19. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery
- •20. Prior treatment with Olaparib or any other PARP inhibitor
- •Additional Durvalumab specific exclusion criteria for cohort B
- •21. Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) =28 days prior to the first dose of study drug. If sufficient wash-out time has not occurred due to the schedule or PK properties of an agent, a longer wash-out period will be required, as agreed by AstraZeneca/MedImmune and the investigator.
- •22. Any unresolved toxicity NCI CTCAE Grade =2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- •a. Patients with Grade =2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
- •b. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with Durvalumab may be included only after consultation with the Study Physician.
- •23. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- •24. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable
- •25. History of allogenic organ transplantation
- •26. History of leptomeningeal carcinomatosis
- •27. Brain metastases or spinal cord compression. Patients with suspected brain metastases at sc
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