EUCTR2011-000348-11-CZ进行中（未招募）不适用
A RANDOMIZED DOUBLE-BLIND PHASE 3 TRIAL COMPARING VINTAFOLIDE (EC145) AND PEGYLATED LIPOSOMAL DOXORUBICIN (PLD/DOXIL®/CAELYX®) IN COMBINATION VERSUS PLD IN PARTICIPANTS WITH PLATINUM-RESISTANT OVARIAN CANCER - PROCEED
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
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.Participants must sign an approved informed consent form (ICF).
- •2.Participants must be = 18 years of age.
- •3.Participants must have pathology-confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
- •4.Participants must have at least a single (RECIST v1.1-defined) measurable target lesion evaluable on etarfolatide SPECT scan by the central nuclear medicine reader.
- •5.Participants must have at least one target lesion positive for folate receptor by etarfolatide scan.
- •6.Participants must have received prior platinum-based chemotherapy for management of primary disease but must not have received more than 2 prior systemic cytotoxic regimens.
- •7.Participants must have platinum-resistant ovarian cancer. Note that primary or secondary platinum resistance is allowed.
- •i. Primary platinum resistance defined as disease that progressed radiologically within 6 months of the last dose of primary platinum therapy.
- •ii. Secondary platinum resistance defined as disease that progressed radiologically during or within 6 months of completing secondary platinum therapy (i.e. last platinum dose)
- •8.Participants are allowed to have received, but are not required to have received, one additional non-cytotoxic anti-tumor agent (eg, biologic or cytostatic) for the management of ovarian cancer.
- •9.For the purpose of obtaining a RECIST v1.1 baseline scan, participants must have a radiological evaluation conducted no more than 28 days prior to beginning study therapy (EC145/Placebo and PLD). Note: For participants with a history of CNS metastasis, baseline radiological imaging must include evaluation of the head.
- •10.Participants must have had prior debulking surgery (with the exception of participants who have primary peritoneal carcinoma not requiring debulking surgery).
- •11.Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- •12.Participants must have recovered (to baseline/stabilization) from prior therapy-associated acute toxicities.
- •13.Participants must have adequate organ function:
- •i.Bone marrow reserve:
- •a)Absolute neutrophil count (ANC) = 1.5x109/L prior to treatment (1.5x109/L is equivalent to 1.5x103/µL and 1.5xK/µL and 1.5x103/cumm and 1500/µL). Participants on maintenance doses of granulocyte colony stimulating factor (G-CSF) are eligible.
- •b)Platelets = 100x109/L (100x109/L is equivalent to 100x103/µL and 100xK/µL and 100x103/cumm and 100,000/µL)
- •c)Hemoglobin = 9 g/dL (9 g/dL is equivalent to 90 g/L and 5.59 mmol/L)
- •d)Use of supportive care measures (eg, use of white blood cell [WBC] growth factors, antiemetics, epoetin) should follow the ASCO guidelines as listed at www.asco.org. Participants should receive full supportive care, including transfusion of blood as mandated by clinical need; however, transfusions administered for the sole purpose of meeting the study inclusion criteria between the time informed consent is signed and first dose of vintafolide/placebo/PLD is administered are not allowed.
- •ii.Hepatic: Total bilirubin level = 1.5 x ULN and alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), and alkaline phosphatase levels = 2.5 x ULN.
- •iii.Renal: Serum creatinine level = 1.5 x ULN or for participants with serum creatinine levels above 1.5 x ULN, creatinine clearance = 50 mL/min/1.73m2 (50 mL/min/1.73m2 is equivalent to 0.83 mL/s/m2).
- •iv.Cardiac: Left ventricular ejection fraction (LVEF) equal to or greater th
排除标准
- •1.Participants’ refractory to primary platinum therapy where refractory” is defined as disease progression within 6 months of first dose of initial platinum-based therapy.
- •2.Diagnosis of tumor of low-malignant potential”.
- •3.Prior exposure to PLD or anthracycline therapy.
- •4.Prior exposure to FR-targeted therapy (eg, vintafolide, EC0225, EC0489, farletuzumab).
- •5.Folic acid intake such as vitamins, or anti-folate therapy such as methotrexate within one week prior to etarfolatide scan.
- •6.Prior therapy with vinorelbine (Navelbine®) or vinca-containing compounds.
- •7.Prior abdominal or pelvic radiation therapy. Prior radiation therapy within the past 3 years to the breast/sternum, dermal lesions, head, or neck.
- •8.Recent (ie, < 6 weeks) history of abdominal surgery or peritonitis.
- •9.Serious co-morbidities (as determined by the investigator) such as, but not limited to, active congestive heart failure or recent myocardial infarction. Participants who require antifolate therapy for the management of co-morbid conditions (eg, rheumatoid arthritis) will be excluded from the trial.
- •10.Participants with bowel obstruction or subocclusion.
- •11.Pregnant or nursing.
- •12.Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).
- •13.Symptomatic central nervous system (CNS) metastasis.
- •14.Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational (ie, used for non-approved indications(s) and in the context of a research investigation). Use of low-dose corticosteroid therapy (eg, for nausea prophylaxis) is acceptable; however, concomitant tamoxifen therapy is not. Supportive care measures are allowed.
- •15.Participants with active infections (e.g. hepatitis or HIV carriers) are excluded from the study.
研究者
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