EUCTR2013-000931-28-IT进行中（未招募）1 期
A Double-blind, Placebo-controlled, Randomized, Phase 2 Study to Evaluate the Efficacy and Safety of Maintenance Therapy With PankoMab-GEX™ After Chemotherapy in Patients With Recurrent Epithelial Ovarian Carcinoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 216
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. 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 =50% from the pretreatment value for patients who have a pretreatment value =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 =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 >6 to =12 months after end of platinum-based chemotherapy and resistant is defined as a recurrence of disease =6 months after the end of platinum-based chemotherapy).
- •8. Eastern Cooperative Oncology Group (ECOG) performance status =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 2).
- •10. Adequate bone marrow and hepatic function at Screening:
- •- Hemoglobin over or equal to 9 g/dL
- •- White blood cell count over or equal to 3.0 × 109/L
- •- Absolute neutrophil count over or equal to 1.5 × 109/L
- •- Platelet count over or equal to 100 × 109/L
- •- Aspartate aminotransferase and alanine aminotransferase <3 × ULN (<5 × ULN in case of liver metastases)
- •- Bilirubin <1.5 × ULN (<3 × ULN in case of liver metastases)
- •- Creatinine <1.5 × ULN.
- •11. Any patient with childbearing potential (i.e., not surgically sterile or postmenopausal for >1 year) must use highly effective contraceptives with a Pearl index <1% according to the Note for guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals (CPMP/ICH/286/95) of the European Medicines Agency (EMA). (Note: although pregnancy is unlikely to occur in this patient population, any patient with childbearing potential will be withdrawn from the study in the event of pregnancy).
- •12. Life expectancy >3 months.
- •13. Ability and willingness to give written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
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 >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.
- •11. Clinically active infections >grade 2 using NCI CTCAE v4.0.
- •12. Active hepatitis B or C or infection with human immunodeficiency virus (HIV).
- •13. Myocardial infarction within 6 months prior to Screening.
- •14. Symptomatic congestive heart failure (New York Heart Association grade 3 or 4), unstable angina pectoris within 6 months prior to Screening, significant cardiac arrhythmia or history of stroke or transient ischemic attack within 1 year prior to Screening.
- •15. Prior or planned major surgery within 30 days prior to randomization and/or incomplete recovery from prior surgery.
- •16. Concomitant use of systemic steroids, except for inhaled, topical or nasal application within 30 days prior to randomization (Note: steroids used for premedication are permitted).
- •17. Active drug or alcohol abuse.
- •18. Any uncontrolled medical condition that may put the patient at high risk during treatment with an investigational drug, including unstable diabetes mellitus, vena cava syndrome, or chronic symptomatic respiratory disease.
- •19. Pregnancy or lactation.
- •20. Legal incompetence, limited legal competence, or detainment in an institution for official or legal reasons.
- •21. Receipt of any other investigational medicinal product within the last 30 days before randomization or any previous PankoMab-GEXTM administration.
研究者
相似试验
进行中（未招募）
1 期
Study to evaluate the efficacy and safety of maintenance therapy with PankoMab-GEX TM after chemotherapy in patients with recurrent epithelial ovarian carcinoma.Recurrent Epithelial Ovarian CarcinomaMedDRA version: 16.0Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-000931-28-ESGlycotope GmbH210
进行中（未招募）
1 期
Study to evaluate the efficacy and safety of maintenance therapy with PankoMab-GEX™ after chemotherapy in patients with recurrent epithelial ovarian carcinoma.Recurrent Epithelial Ovarian, Fallopian Tube or Primary High Grade Peritoneal CarcinomaMedDRA version: 19.0Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: LLTClassification code 10052171Term: Peritoneal carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-000931-28-DEGlycotope GmbH210
进行中（未招募）
1 期
Study to evaluate the efficacy and safety of maintenance therapy with PankoMab-GEX™ after chemotherapy in patients with recurrent epithelial ovarian carcinoma.Recurrent Epithelial Ovarian CarcinomaMedDRA version: 19.0Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-000931-28-HUGlycotope GmbH210
进行中（未招募）
1 期
Study to evaluate the efficacy and safety of maintenance therapy with PankoMab-GEX™ after chemotherapy in patients with recurrent epithelial ovarian carcinoma.Recurrent Epithelial Ovarian, Fallopian Tube or Primary High Grade Peritoneal Carcinoma.MedDRA version: 19.0 Level: PT Classification code 10016180 Term: Fallopian tube cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0 Level: LLT Classification code 10052171 Term: Peritoneal carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0 Level: PT Classification code 10066697 Term: Ovarian cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-000931-28-GBGlycotope GmbH210
进行中（未招募）
1 期
Study to evaluate the efficacy and safety of maintenance therapy with PankoMab-GEX™ after chemotherapy in patients with recurrent epithelial ovarian carcinoma.EUCTR2013-000931-28-PLGlycotope GmbH210