A Phase II, Double-Blind, Placebo Controlled, Multi-Centre, Randomised Study of AZD0530 in Patients with Advanced Ovarian Cancer Sensitive to Platinum-Based Chemotherapy - (OVERT-1)

AstraZeneca AB0 个研究点目标入组 200 人开始时间: 2009年1月12日最近更新: 2019年11月25日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: AstraZeneca AB
入组人数: 200

研究概览入排标准研究者记录与标识符相似试验

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

入选标准

•1. Provision of signed, written informed consent 2. Females aged 18 years and older 3. Histologically proven diagnosis of: - Epithelial ovarian carcinoma - Fallopian tube carcinoma - Primary serous peritoneal carcinoma 4. Advanced disease not amenable to curative surgery or radiotherapy at the time of study entry 5. Radiological evidence of disease recurrence or progression at least 6 months following treatment cessation of first or second line platinum containing therapy (including platinum based maintenance therapy) 6. Documented non-measurable or measurable lesion according to RECIST criteria assessed by Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI) 7. World Health Organisation (WHO) performance status 0 to 2 8. Estimated life expectancy of more than 12 weeks 9. Evidence of non-childbearing status: negative pregnancy test within 7 days of study treatment if of childbearing potential, or postmenopausal status (defined by any one of the following: natural menopause with last menses >1 year ago; radiation-induced oophorectomy with last menses >1 year ago, chemotherapy-induced menopause with >1 year interval since last menses) or surgical sterilisation (bilateral oophorectomy or hysterectomy) 10. For inclusion in the optional pharmacogenetic research, patients must fulfil the following criterion: Provision of informed consent for pharmacogenetic research If a patient declines to participate in the pharmacogenetic research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in the Clinical Study Protocol, so long as they consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•1. Clinical evidence of central nervous system (CNS) metastases 2. Non-epithelial ovarian cancer, including malignant mixed Mullerian tumours and mucinous carcinoma of the peritoneaum 3. Tumour of borderline malignancy 4. A second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) 5. Inadequate bone marrow reserve as demonstrated either by an absolute neutrophil count <1.5 x 10 to the power of 9/L or platelet count <100 x 10 to the power of 9/L 6. Haemoglobin =9 g/dL (5.59 mMol/L) 7. Inadequate liver function as demonstrated by serum bilirubin =2 times the upper limits of reference range (ULRR), alanine aminotransferase (ALT), aspartate aminotransferase (AST) or ALP =2.5 times the ULRR (ALP =5 times the ULRR if judged by the investigator to be related to liver metastases) 8. Patients with estimated GFR1 year ago, radiation induced oophorectomy with last menses >1 year ago, chemotherapy-induced menopause with >1 year interval since last menses or surgical sterilisation (bilateral oophorectomy or hysterectomy) 15. Unresolved toxicity =CTCAE grade 2 from previous anti-cancer therapy except alopecia 16. Symptomatic peripheral neuropathy =NCIC-CTC grade II 17. Patients believed to have a known immunodeficiency syndrome 18. Resting ECG with measurable QTc interval of >480 msec at 2 or more time points within a 24 hour period 19. Current use or previous use within specified time period (detailed in CSP Appendix E) of drugs or herbal supplements known to be potent inducers or inhibitors of CYP3A4 20. Known hypersensitivity to AZD0530, its excipients, or drugs in its class 21. Cannot be adequately followed up for the duration of their study participation. 22. Participation in another study with an investigational product within the previous 90 days or participation in a previous clinical study within 30 days prior to study entry 23. Risk (in the investigator’s opinion) of transmitting, through blood or other body fluids, the agents responsible for Acquired Immunodeficiency Syndrome, hepati

研究者

发起方

AstraZeneca AB

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A Phase II, Double-Blind, Placebo Controlled, Multi-Centre, Randomised Study of AZD0530 in Patients with Advanced Ovarian Cancer Sensitive to Platinum-Based Chemotherapy - (OVERT-1)advanced ovarian cancer sensitive to platinum based chemotherapyMedDRA version: 9.1Level: HLTClassification code 10033129Term: Ovarian neoplasms malignant (excl germ cell)

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AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer OVERT-1

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A Phase II, Double-Blind, Placebo Controlled, Multi-Centre, Randomised Study of AZD0530 in Patients with Advanced Ovarian Cancer Sensitive to Platinum-Based Chemotherapy Estudio fase II, doble ciego, controlado con placebo, multicéntrico, aleatorizado de AZD0530 en pacientes con cáncer de ovario avanzado sensible a la quimioterapia basada en platino (OVERT-1) - (OVERT-1)advanced ovarian cancer sensitive to platinum based chemotherapycáncer de ovario avanzado sensible a la quimioterapia basada en platinoMedDRA version: 9.1Level: HLTClassification code 10033129Term: Ovarian neoplasms malignant (excl germ cell)

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