EUCTR2007-005325-30-PT进行中（未招募）不适用
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)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
- •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
- •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 GFR9.Last dose of anti-cancer therapy received within 14 days prior to the first dose of treatment with study drug. If insufficient wash-out time has not occurred due to schedule or PK properties, a longer wash-out period will be required according to expected time to anti-tumour effect, or known duration and time to reversibility of drug related AEs, as agreed upon by AstraZeneca and the Investigator
- •10.Received more than two previous chemotherapy regimens for treatment of ovarian cancer
- •11.Evidence of uncontrolled systemic conditions (eg, severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]) or current unstable or uncompensated respiratory or cardiac conditions which makes it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol
- •12.Any other concurrent condition which in the investigator’s opinion makes it
- •undesirable for the patient to participate in the trial or which would jeopardise
- •compliance with the protocol
- •13. Pregnant or breast-feeding women
- •14. Unwillingness to use an acceptable method of contraception while on study (for
- •women of child bearing potential) and for three months after cessation of dosing
- •with AZD0530. Post-menopausal status will be considered adequate evidence of
- •non-childbearing potential and is defined as any 1 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)
- •15. Unresolved toxicity =CTCAE grade 2 from previous anti-cancer therapy except
- •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
研究者
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