CTIS2024-511780-28-00招募中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) - AGO-OVAR 27
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- 18 至 65+（—）
入选标准
- •WoO pre-treatment (screening phase): Patients with presumed and previously untreated advanced stage ovarian cancer planned to undergo laparoscopy for histologic diagnosis and treatment planning, WoO pre-treatment (screening phase): Ability to take oral medication, WoO pre-treatment (screening phase): Postmenopausal or evidence of non-childbearing status for women of childbearing potential (WOCBP): negative serum pregnancy test within 28 days of study treatment and confirmed negative urine or serum pregnancy test 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), WoO pre-treatment (screening phase): 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 6 months 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: 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, WoO treatment phase: Planned primary debulking surgery after confirmation of diagnosis and disease evaluation during laparoscopy, WoO treatment phase: Body weight >30kg, WoO treatment phase: 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 function test might not be candidates for primary debulking surgery), - Patients must have creatinine clearance estimated of =51 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test: Estimated creatinine clearance=((140-age [years])*weight (kg))/(serum creatinine (mg/dL)*72)(* 0,85), WoO treatment phase: Patients must have successfully contributed blood and tissue samples as per requirements, WoO pre-treatment (screening phase): 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, WoO pre-treatment (screening phase): Patients able and willing to provide fresh frozen biopsy samples from laparoscopy as well as primary debulking for translational endpoints as well as serial liquid biopsies, WoO pre-treatment (screenin
排除标准
- •Medical conditions: Disease requiring urgent surgical intervention, Medical conditions: Brain metastases or spinal cord compression. Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry, Prior / concomitant therapy: Prior antineoplastic therapy for ovarian, fallopian tube or primary peritoneal cancer, Medical conditions: Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days., Prior / concomitant therapy: Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment, Prior / concomitant therapy: Any concurrent chemotherapy, investigational medicinal product (IMP), biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable, Prior / concomitant therapy: Patients planned for neoadjuvant chemotherapy or deemed unresectable at laparoscopy, Prior / concomitant therapy: Concomitant use of known strong CYP3A inhibitors (eg. Itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. Ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting Olaparib is 2 weeks., Prior / concomitant therapy: Concomitant use of known strong (eg. Phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John’s Wort) or moderate CYP3A inducers (eg. Bosentan, efavirenz, modafinil). The required washout period prior to starting Olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents, Prior / concomitant therapy: Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery, Prior / concomitant therapy: History of allogenic organ transplantation, Medical conditions: Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients., Prior / concomitant therapy: Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)., Prior / concomitant therapy: Patients with a known hypersensitivity to Olaparib or any of the excipients of the product., Prior / concomitant therapy: Prior treatment with Olaparib or any other PARP inhibitor, Medical conditions: Evidence of central nervous system (CNS) or leptomeningeal metastases., Prior / concomitant therapy: Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable, for timing refer to inclusion criteria no. 16), Other exclusions: Patients who are pregnant or breastfeeding or patients of reproductive potential who are not willing to employ effective birth control from screening to 6 months after the last dose of study drug(s)., Other exclusions: Involvement in the planning and/or conduct of the study, Othe
研究者
相似试验
进行中（未招募）
1 期
A clinical trial to test the feasibility of a treatment with Olaparib (cohort A) or Olaparib in combination with Durvalumab (cohort B) given to patients with ovarian cancer during the time slot between diagnosis and primary debulking surgery.Patients with presumed and previously untreated advanced stage ovarian cancer planned to undergo laparoscopy for histologic diagnosis and treatment planning.EUCTR2020-005101-12-DEAGO Research GmbH60
招募中
2 期
Progesterone as an anticancer therapy in breast cancerCancer - BreastBreast CancerACTRN12618000928213St Vincent's Hospital, Sydney200
招募中
4 期
A computerized visual training study for visual stimulation in Patients Suffering from Keratoconus.CTRI/2022/09/045779one
招募中
2 期
â??To study the Immunomodulatory effects of Withania somnifera (ASHWAGANDHA) in patients of pulmonary tuberculosisâ??CTRI/2008/091/000089Government Medical College, Jammu120
进行中（未招募）
1 期
A randomized, open-label, adaptive, proof-of-concept clinical trial of modulation of host thromboinflammatory response in patients with COVID-19.COVID-19MedDRA version: 20.0Level: LLTClassification code 10038700Term: Respiratory infectionSystem Organ Class: 100000004862EUCTR2020-001739-28-BEZLeuven210