NL-OMON46453已完成2 期
A Multicentre Phase II Study of AZD1775 plus Chemotherapy in Patients with Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. - AZD1775 + Chemotherapy to treat Ovarian, Fallopian Tube, Peritoneal Cancer.
Astra Zeneca0 个研究点目标入组 6 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
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 99（—）
入选标准
- •1. Has read and understands the informed consent form (ICF) and has given written consent.;2. Histologic or cytologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer.;3. Progressed within 6 months of completing at least 4 cycles of a first-line platinum-containing regimen for Stage III/IV disease. Patients with refractory disease (progression during platinum-containing therapy) are ineligible.;4. No more than 2-4 prior treatment regimens for Stage III/IV disease, defined as investigational, chemotherapy, hormonal, biologic, or targeted therapy.;5. Prior doxorubicin (or other anthracycline) at a cumulative dose of * 360 mg/m² or cumulative epirubicin dose of * 720 mg/m² (calculated using doxorubicin equivalent doses: 1 mg of doxorubicin <= 1 mg PLD <= 0.3 mg mitoxantrone <= 0.25 mg idarubicin). Subjects without any prior anthracycline exposure can also be included (applies to Arm D only).;6. At least 1 measurable lesion according to RECIST v1.1.;7. Any prior palliative radiation therapy must be completed at least 7 days prior to start of study treatment and patients must have recovered from any acute adverse effects prior to start of study treatment. ;8. ECOG Performance Status (PS) score of 0 - 1.;9. Baseline Laboratory Values within 7 days of starting study drugs:
- •a) ANC *1500/*L
- •b) HgB * 9 g/dL with no blood transfusions in the past 28 days
- •c) Platelets * 100,000/*L
- •d) ALT & AST * 3 x ULN or * 5 x ULN if known hepatic metastases
- •e) Serum bilirubin within normal limits (WNL) or *1.5 x ULN in patients with liver metastases; or total bilirubin * 3.0 x ULN with direct bilirubin WNL in patients with well documented Gilbert*s Syndrome.
- •f) Serum creatinine *1.5 x ULN OR measured creatinine clearance (CrCl) * 45 mL/min by the Cockcroft-Gault method.;10. Left ventricular ejection fraction (LVEF) WNL of the institution, as determined by multiple uptake gated acquisition (MUGA) or echocardiography (ECHO) (applies to Arm D only).;11. Female patients who are not of childbearing potential and fertile female patients of
- •childbearing potential who agree to use adequate contraceptive measures from 2
- •weeks prior to the study and until 1 month after study treatment discontinuation,
- •who are not breastfeeding, and who have a negative serum or urine pregnancy test
- •within 3 days prior to start of study treatment;12. Predicted life expectancy * 12 weeks;13. Must be *18 years of age.;14. Willingness and ability to comply with study and follow-up procedures.
排除标准
- •1. Participation in another clinical investigational study within the previous 28 days. ;2. Use of a study drug (approved or investigational drug therapy) * 21 days or 5 half-lives
- •(whichever is shorter) prior to the first dose of study treatment. For study drugs for which 5 half-lives is * 21 days, a minimum of 10 days between termination of the study drug and administration of study treatment is required.;3. Major surgical procedures * 28 days of beginning study treatment, or minor surgical
- •procedures * 7 days. No waiting required following port-a-cath placement, or any other central venous access placement.;4. No other chemotherapy, immunotherapy, hormonal anti-cancer therapy, radiotherapy (except for palliative local radiotherapy), biological therapy or other novel agent is permitted while the patient is receiving study medication. ;5. Grade >1 toxicity from prior therapy (except alopecia or anorexia).;6. Known malignant CNS disease other than neurologically stable, treated brain metastases * defined as metastasis having no evidence of progression or haemorrhage after treatment for at least 2 weeks (including brain radiotherapy). Must be off any systemic corticosteroids for the treatment of brain metastases for at least 14 days prior to enrolment.;7. Any prescription or non-prescription drugs or other products (i.e. grapefruit juice) known to be sensitive CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors or inducers of CYP3A4, which cannot be discontinued 2 weeks prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study drug.
- •8. Any of the following cardiac diseases currently or within the last 6 months as defined by New York Heart Association (NYHA) * Class 2:
- •a) Unstable angina
- •b) Congestive heart failure
- •c) Acute myocardial infarction
- •d) Conduction abnormality not controlled with pacemaker or medication
- •e) Significant ventricular or supraventricular arrhythmias (patients with chronic rate controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible).;9. AZD1775 should not be given to patients with a history of Torsades de pointes unless all risk factors that contributed to Torsades have been corrected. AZD1775 has not ben studied in patients with ventricular arrhythmias or recent myocardial infarction.;10. Corrected QT interval (QTc) >470 msec at study entry or congenital long QT syndrome. QTc interval will be calculated using Fridericia's formula (per institutional standards) obtained from 3 ECGs performed 2-5 minutes apart at study entry.
- •11.Pregnant or lactating.;12. Serious active infection upon enrolment, or other serious underlying medical condition that would impair the patient's ability to receive study treatment. ;13. Presence of other active cancers, or history of treatment for invasive cancer within the last 3 years. Patients with Stage I cancer who have received definitive local treatment within the last 3 years, and whom are considered unlikely to recur, are eligible. All patients with previously treated in-situ carcinoma (i.e., non-invasive) are eligible, as are patients with prior non-melanoma skin cancers.;14. Psychological, familial, sociological, or geographic conditions that do not permit compliance with the protocol.
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