EUCTR2019-003884-23-BG进行中（未招募）1 期
The OVAL Study: A Randomized, Controlled, Double-Arm,Double-Blind, Multi-Center Study of Ofranergene Obadenovec (VB-111) Combined with Paclitaxel vs. Paclitaxel Combined with Placebo for the Treatment of Recurrent Platinum-Resistant Ovarian Cancer - OVA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
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
- •Patients who meet ALL of the following criteria will be considered for enrollment into this study:
- •1. Signed informed consent must be obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient’s awareness and willingness to comply with the study requirements.
- •2. Female patients =18 years of age.
- •3. Histologically confirmed epithelial ovarian cancer (including primary peritoneal and fallopian tube) and documented disease.
- •4. Patients must have platinum-resistant disease, defined as a CT confirmed progressive disease within 90 to 180 days from completion of a minimum of 4 platinum therapy cycles (the time should be calculated from the last administered dose of platinum therapy to the day of CT confirming progression), or a platinum-refractory disease defined as CT confirmed progression during platinum therapy or up to 90 days from the last administered dose of platinum therapy.
- •5. Patients must have disease that is measurable according to RECIST 1.1 and require chemotherapy treatment.
- •6. ECOG PS 0–1.
- •7. Adequate hematological functions:
- •a. ANC = 1000/mm3
- •b. PLT = 100,000/mm3
- •c. PT and PTT (seconds) < 1.2 X ULN.
- •Patients who are anticoagulated do not need to meet criteria for PT and PTT.
- •8. Patients must have no evidence of bowel involvement on CT, or clinical symptoms of bowel obstruction.
- •9. Patients must have a life expectancy of =12 weeks.
- •10. Patients who are of childbearing potential must agree to use two methods of reliable contraception simultaneously or to practice complete abstinence from heterosexual contact. One method must include a highly effective method such as an intrauterine device, hormonal (birth control pills injections or implants), tubal ligation or partner’s vasectomy and one can be an additional (barrier method such as a male condom, diaphragm or cervical cap or hormonal). Contraception/abstinence should be used prior to study entry, while receiving treatment and for 2 months after last study treatment administration. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. All patients of childbearing potential must have negative pregnancy test (using serum or urine) within 14 days prior to randomization. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study.
- •- A woman is considered not to be of childbearing potential if she is postmenopausal, defined by amenorrhea of > 12 months duration and age > 45 years, or has undergone hysterectomy and/or bilateral oophorectomy.
- •11. Patients who are known to carry a BRCA mutation may be enrolled only after failing a PARP inhibitor treatment, or being intolerant of, or ineligible for PARP inhibitor treatment
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Patients who meet ANY of the following criteria will be excluded from participation in this study:
- •1. Non-epithelial tumors (Carcino-sarcomas are excluded).
- •2. Ovarian tumors with low malignant potential (i.e. borderline tumors), clear cell carcinomas, grade 1 serous tumors or mucinous adenocarcinomas.
- •3. History of other clinically active malignancy within 5 years of enrollment, except for tumors with a negligible risk for metastasis or death, such as adequately controlled skin basal-cell carcinoma, adequately controlled, nonmetastatic squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast.
- •4. Previous ovarian cancer treatment with >5 anticancer regimens.
- •5. Patients who had evidence of disease progression during or up to 90 days from the first line of platinum based therapy.
- •6. Treatment with another anti-cancer therapy within 14 days of randomization; or current or recent treatment with another investigational drug within 30 days of day of randomization; or previous randomization to this study.
- •7. Patients who received anti-angiogenic therapy (including anti-angiogenic Tyrosine Kinase Inhibitors) within the previous 4 weeks prior to day of randomization.
- •8. Any prior radiotherapy to the pelvis or whole abdomen (vaginal brachytherapy is allowed).
- •9. Surgery (including open biopsy) within 4 weeks prior to day of randomization, or anticipation of the need for major surgery during study treatment.
- •10. Minor surgical procedures, within 24 hours prior to day of randomization.
- •11. Patients with an ongoing requirement for significant immunosuppressive treatment, including the use of cyclosporine, or with a history of chronic use of any such medication within the last 4 weeks prior to day of randomization, excluding inhaled, topical and intra-articular steroids. A stable dose (e.g. started at least 2 weeks prior to randomization) of corticosteroids is allowed if the dose is <10 mg/day methylprednisolone equivalent.
- •12. Inadequate liver function, defined as:
- •a. serum (total) bilirubin > ULN (Exception: documented Gilbert’s disease patients can be enrolled)
- •b. alkaline phosphatase, AST/SGOT or ALT/SGPT =2.5 x ULN (or = 5 x ULN in the presence of liver metastases).
- •13. Inadequate renal function, defined as serum creatinine > ULN, unless calculated creatinine clearance > 50ml/min (by Cockroft & Gault formula).
- •14. Known history of testing positive for HIV, HBV or HCV. NOTE: patients with serology positive for HBV indicating past exposure but without evidence for active infection (e.g. negative PCR) are eligible.
- •15. CTCAE v5 Grade 2 or greater neuropathy (motor or sensory) from comorbidity, such as diabetes, or prior chemotherapy.
- •16. New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- •17. History of myocardial infarction or unstable angina within 6 months prior to day of randomization.
- •18. History of stroke or transient ischemic attack within 6 months prior to day of randomization.
- •19. Patient with proliferative and/or vascular retinopathy.
- •20. Known brain metastasis.
- •21. Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to day of randomization.
- •22. History of hemoptysis (>1/2 teaspoon of bright red blood per episode) or active GI bleeding within 6 months prior to day of randomization.
- •23. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
研究者
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