DRKS00005501已完成1 期
A two-part, multicentre, international phase I and II trial assessing the safety and efficacy of the Hsp90 inhibitor ganetespib in combination with paclitaxel weekly in women with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer - GANNET53
Medizinische Universität InnsbruckAGO Österreich StudienzentrumAbteilung für Gynäkologie und Geburtshilfe0 个研究点目标入组 133 人开始时间: 2014年10月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 133
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- Female
入选标准
- •Patients must meet the following criteria to be eligible for study entry:
- •Ability to understand and willingness to sign and date a written informed consent document
- •Female patients =18 years of age High-grade serous, high-grade endometrioid, or undifferentiated epithelial ovarian, fallopian tube or primary peritoneal cancer.
- •o Patients in part II: High-grade serous, high-grade endometrioid, or undifferentiated epithelial ovarian, fallopian tube or primary peritoneal cancer confirmed by central histophathology through archival FFPE or fresh-frozen tumour samples. Platinum-resistant disease:
- •o primary platinum-resistant disease: progression > 1 month and = 6 months after completion of primary platinum-based therapy
- •o secondary platinum-resistant disease (including secondary platinum-refractory disease): progression = 6 months after (or during) reiterative platinum-based therapy Patients must have disease that is measurable according to RECIST 1.1 or assessable according to the GCIG CA-125 criteria ECOG performance status of 0-1 Life expectancy of at least 3 months as assessed by the investigator Adequate function of the bone marrow:
- •o Platelets =100 x 109/L
- •o Absolute neutrophil count (ANC) = 1.5 x 109/L Haemoglobin = 8.5 g/dl. Patients may receive blood transfusion(s) to maintain haemoglobin values > 8.5 g/dl. Adequate organ functions:
- •o Creatinine < 2 mg/dl (<177 µmol/L)
- •o Total bilirubin = 1.5 x upper limit of normal
- •o SGOT/SGPT (AST/ALT) = 3 x upper limit of normal
- •o Urinanalysis or urine dipstick for proteinuria less than 2+. Patients with = 2+ on dipstick should undergo 24-hour urine collection and must demonstrate < 1 g of protein/24 hours. Alternatively, proteinuria testing can be performed according to local standards Negative urine/serum pregnancy test in women of childbearing potential (WOCBP, see section 5).
- •Adequate coagulation parameters: aPTT = 1.5 x ULN (patients on heparin treatment must have an aPTT between 1.5 – 2.5 x ULN), or
- •INR = 1.5. (In patients receiving anticoagulants (such as warfarin) INR must be between 2.0 and 3.0 in two consecutive measurements
- •1-4 days apart).
- •Negative urine/serum pregnancy test in women of childbearing potential (WOCBP, see section 5). WOCBP who are sexually active, agree to use highly-effective means of contraception during the study and for at least 6 months post-study treatment. Allowed are accepted and effective non-hormonal methods of contraception and sexual abstinence or vasectomised partners (> 3 months previously). Vasectomy has to be confirmed by two negative semen analyses.
- •Only in part II of the trial: Availability of archival ovarian cancer tissue for central histopathological review and p53 mutational analysis
排除标准
- •Patients who meet any of the following criteria will be excluded from study entry:
- •CANCER-RELATED:
- •1. Ovarian tumours with low malignant potential (i.e. borderline tumours), Carcinosarcoma of the ovary
- •2.. Primary platinum-refractory disease (progression during primary platinum-based chemotherapy)
- •PRIOR, CURRENT OR PLANNED TREATMENT:
- •3. Previous treatment with > 2 chemotherapy regimens in the platinumresistant setting (excluding targeted and endocrine therapies).
- •4. Previous weekly paclitaxel in relapse treatment
- •5. More than 4 previous lines of chemotherapy.
- •6. Any prior radiotherapy to the pelvis or abdomen
- •7. Surgery (including open biopsy and traumatic injury) within 4 weeks prior to first dose of ganetespib, or anticipation of the need for major surgery during study treatment
- •8. Minor surgical procedures, within 24 hours prior to the first study treatment
- •9. Current or recent (within 10 days prior to the first study drug dose) chronic daily treatment with aspirin (>325 mg/day).
- •10. Chronic daily treatment with corticosteroids (dose >10 mg/day methylprednisolone equivalent), excluding inhaled steroids.
- •PRIOR OR CONCOMITANT CONDITIONS OR PROCEDURES:
- •11. Patients with a history of prior malignancies, except: o disease-free time-frame of = 3 years prior to randomisation.
- •12. Patients with prior in-situ carcinomas, except: o complete removal of the tumour is given
- •13. Known history of severe (grade 3 or 4) allergic or hypersensitivity reactions to excipients (e.g. polyethylene glycol [PEG] 300 and Polysorbate 80)
- •14. History of intolerance or hypersensitivity to paclitaxel and/or adverse events related to paclitaxel that resulted in paclitaxel being
- •permanently discontinued
- •15. Peripheral neuropathy of grade > 2 per NCI CTCAE, version 4.03, within 4 weeks prior to randomisation
- •16. Clinically significant gastro-intestinal (GI) tract abnormalities that may increase the risk for GI bleeding and/or perforation including but not limited to: active peptic ulcer disease, known intraluminal metastatic lesion/s with risk of bleeding, inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), history of bowel obstruction within 1 year prior to first study treatment (excluding postoperative,
- •i.e. within 4 weeks post surgery), other GI condition with increased risk of perforation such as a recurrence deeply infiltrating into the muscularis or mucosa of the rectosigmoid or the mucosa of the bladder, or history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
- •17. Non-healing wound or non-healing bone fracture
- •18. Patients with symptomatic brain metastases
- •19. Left ventricular ejection fraction defined by ECHO below the institutional lower limit of normal
- •20. Cerebrovascular accident (CVA) / stroke or transient ischemic attack (TIA) or sub-arachnoid haemorrhage within =6 months prior to first study treatment.
- •21. Significant cardiac disease: New York Heart Association (NYHA) Class 3 or 4; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty or coronary artery bypass graft (CABG) within the past 6 months; or uncontrolled atrial or ventricular cardiac arrhythmias.
- •22. History of prolonged QT syndrome, or family member with prolonged QT syndrome
- •23. QTc interval > 470 msec when 3 consecutive ECG values are averaged
- •24. Ventricular tachycardia or a supraventricular tachycardia that requires treatment with a Class Ia antiarrhythmic drug (e.g. quinidine, procainamide, disopyramide
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