EUCTR2015-005137-42-ES进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Neoadjuvant Carboplatin and Paclitaxel, With or Without Debio 1143 in Patients With Newly Diagnosed Advanced Epithelial Ovarian Cancer.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 84
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. Women ? 18 years ? 70 years.
- •2. Patient with newly diagnosed, histologically confirmed (cytology alone excluded) high-grade serous ovarian cancer and high-grade endometrioid ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma.
- •For patients with endometrioid cancer, only grade 3 defined by morphological features and immunohistochemical staining are eligible.
- •3. Documented FIGO stage IIIC-IV confirmed by laparoscopy (or mini-laparotomy) and imaging AND unsuitable for primary complete cytoreductive surgery.
- •4. Medically fit to undergo surgical cytoreduction after 4 cycles of neoadjuvant chemotherapy.
- •5. Eligible for carboplatin and paclitaxel chemotherapy.
- •6. Tumour biopsy sample for exploratory analysis.
- •7. ECOG performance score 0-2.
- •8. Life expectancy of at least 6 months in the best judgement of the investigator.
- •9. Minimum of one measurable tumour lesion, according to the RECIST 1.1 criteria (measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ? 20 mm by chest x-ray, as ? 10 mm with CT scan, or > 10 mm with calipers by clinical exam. Lymph nodes with a short axis ? 15 mm are considered to be measurable and assessable as target lesions).
- •10. Adequate bone marrow, renal and liver function: calculated creatinine clearance ? 50 mL/min as determined by the modified Cockcroft method; absolute neutrophil count ? 1500/?L, platelets ? 100000/?L, haemoglobin ? 9 g/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 4 × ULN; total bilirubin ? 2.0 mg/dL.
- •11. Serum albumin level ? lower limit normal (LLN).
- •12. Women of child-bearing potential must
- •o Have a negative serum pregnancy test at screening.
- •o Agree to use appropriate contraception method from time of study entry to surgery or up to 6 months after the last day of treatment.
- •13. No active rheumatoid arthritis, active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation.
- •14. QTcF interval ? 480 milliseconds.
- •15. Able to take oral medication and has no condition or prior surgical procedure affecting absorption.
- •16. Able to understand and voluntarily sign an informed consent form.
- •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 73
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •1. History of another active malignancy within the preceding 3 years, except for adequately treated carcinoma in situ of the cervix, breast, and non-melanomatous skin.
- •2. Mucinous, clear cell, and carcinosarcoma histologies.
- •3. Clinical evidence of brain or leptomeningeal metastases.
- •4. Serious disabling disease contraindicating cytoreductive surgery such as, but not limited to, New York Heart Association (NYHA) grade 3/4 congestive heart failure and severe pulmonary disease.
- •5. Major surgery within 28 days prior to the first dose of study treatment and not fully recovered to baseline or to a stable clinical status.
- •6. Human immunodeficiency virus (HIV) infection (testing required)
- •7. Known history of HBV or HCV (testing not required in the absence of clinical findings or suspicion).
- •8. Pre-existing sensory or motor neuropathy NCI-CTCAE v 4.03 ? 2.
- •9. Any psychological familial, sociological or geographical condition potentially preventing compliance with the study protocol schedule.
- •10. Prior treatment with an inhibitor of apoptosis protein (IAP) inhibitors.
- •11. Known allergic reaction triggered by Debio 1143 or its excipients.
- •12. Use or requirement for use of aspirin or aspirin-containing products with > 160 mg of aspirin per day.
- •13. Concurrent treatment with prohibited medications
研究者
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