A Double-blind, Placebo-controlled, Randomized, Phase 2 Study to Evaluate the Efficacy and Safety of Maintenance Therapy With PankoMab-GEX TM After Chemotherapy in Patients With Recurrent Epithelial Ovarian Carcinoma

Glycotope GmbH0 个研究点目标入组 210 人2013年5月16日

适应症Recurrent Epithelial Ovarian Carcinoma MedDRA version: 16.0Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Recurrent Epithelial Ovarian Carcinoma
发起方: Glycotope GmbH
入组人数: 210
状态: 进行中（未招募）
最后更新: 8年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2013年5月16日

结束日期

待定

最后更新

8年前

研究类型

Interventional clinical trial of medicinal product

性别

Female

研究者

发起方

Glycotope GmbH

入排标准

入选标准

•1\. Female patients over or equal to 18 years of age.
•2\. Histologically confirmed, TA\-MUC1 positive, recurrent epithelial ovarian carcinoma.
•3\. Availability of tumor tissue samples (slices or block) for immune\-histological confirmation of TA\-MUC1 status (tissue samples may also be stored for other further specified biomarker assessments).
•4\. Patients should have received at least 2 lines but not more than 4 lines of chemotherapy prior to start of maintenance treatment.
•5\. Documented response to or stable disease following the most recent line of chemotherapy (any regimen and duration in accordance with local or international guidelines or within independent ethics committee \[IEC] approved studies) and received last dose of said chemotherapy maximum 5 weeks prior to randomization (response to prior chemotherapy is defined as a partial/complete response according to radiological response criteria and/or a confirmed decline in tumor marker CA125 higher or equal to 50% from the pretreatment value for patients who have a pretreatment value higher or equal to 2 x the upper limit of normal \[ULN]; stable disease is defined as stable disease according to radiological response criteria with a confirmed lack of increase in tumor marker CA125 from the pretreatment value for patients who have a pretreatment value higher or equal to 2 x ULN and no clinical progression). CA125 prior to randomization must be below ULN or CA125 levels must not increase \>15% within a time frame \>7 days if above ULN.
•6\. Treatment\-free interval of maximum12 months immediately preceding the chemotherapy to which the patient has just responded.
•7\. Sensitive or resistant to the most recent platinum\-based chemotherapy preceding the chemotherapy to which the patient has just responded (sensitive is thereby defined as a recurrence of disease more than 6 months to less or equal to 12 months after end of platinum\-based chemotherapy and resistant is defined as a recurrence of disease less or equal to 6 months after the end of platinum\-based chemotherapy).
•8\. Eastern Cooperative Oncology Group (ECOG) performance status lower or equal to 1\.
•9\. Recovered from all chemotherapy\-related toxicities to grade 1 or grade 0 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4\.0, with the exception of alopecia (any grade) and peripheral neuropathy (grade lower or equal to 2\).
•10\. Adequate bone marrow and hepatic function at Screening:

排除标准

•1\. Refractory to platinum\-based chemotherapy (defined as remained progressive or became progressive under any previous platinum\-based regimen).
•2\. Treatment\-free interval of more than 12 months after the most recent antecedent platinum\-based chemotherapy regimen.
•3\. Concomitant anti\-tumor therapy or immunotherapy.
•4\. Treatment with monoclonal antibodies or investigational agents maximum 30 days before randomization (Note: prior anti\-MUC1 therapy is not permitted at any time).
•5\. Limited field radiotherapy maximum 30 days before randomization (Note: extensive prior radiotherapy during or following the last line of chemotherapy is not permitted; radiotherapy prior to the last line of chemotherapy is permitted).
•6\. Prior allergic reaction to a monoclonal antibody, grade 3 infusion related reaction (IRR) or any grade 4 reaction to a monoclonal antibody.
•7\. Known sensitivity to any component of the test product.
•8\. Contraindication to the premedications used in this study (paracetamol/acetaminophen, H1 and/or H2 receptor antagonists, and steroids).
•9\. Clinical evidence of brain metastasis or leptomeningeal involvement.
•10\. Primary or secondary immune deficiency.