EUCTR2015-000886-30-NL进行中（未招募）1 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.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 97
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. 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/µL
- •b) HgB = 9 g/dL with no blood transfusions in the past 28 days
- •c) Platelets = 100,000/µL
- •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.
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
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,
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