EUCTR2011-000266-35-IT进行中（未招募）不适用
A phase II, open-label, single-arm, non-randomized, multi-center study to evaluate the efficacy of oral TKI258 as second-line therapy in patients witheither FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- All
入选标准
- •1. Female patients aged = 18 years 2. Histologically confirmed diagnosis of advanced and/or metastatic endometrial cancer • Eligible histologies include: endometrioid, uterine papillary serous carcinoma, papillary endometrioid, clear cell, mucinous, adenosquamous, and mixed types (e.g., endometrioid plus serous papillary and/or clear cell) 3. Available tissue specimen, either archival tissue or a fixed fresh biopsy, for assessment of FGFR2 mutation • Confirmation by Novartis-designated laboratory of whether a patient has FGFR2 mutation or is wild-type 4. Documented radiological evidence of progressive disease, as per RECIST v1.1 (Section 14.1), after first-line antineoplastic treatment for advanced and/or metastatic endometrial cancer. One prior line of antineoplastic treatment is defined as: • First-line treatment for metastatic disease including at least one cytotoxic agent • Any neoadjuvant/adjuvant treatment is not considered a prior line of treatment, unless the recurrence occurred while on neoadjuvant/adjuvant chemotherapy or = 6 months since the last administration of neoadjuvant/adjuvant chemotherapy, in which case the neoadjuvant/adjuvant therapy will be considered as one prior regimen of systemic chemotherapy for advanced disease • Any prior hormonal treatment is not considered a line of treatment in any setting 5. Complete recovery from major side effects of prior anticancer radiotherapy and from any drug-related adverse events derived from previous anticancer treatments, excluding alopecia and CTCAE grade 1 peripheral neuropathy 6. Patient has at least one measurable lesion based on RECIST v1.1 (Section 14.1) as determined by the investigator. Lesions in previously irradiated areas should not be selected as target lesions, unless they have clearly progressed since the radiotherapy. 7. ECOG performance status = 2 8. Patients must have the following laboratory values: • Absolute neutrophil count = 1.5 x 109/L • Platelets = 100 x 109/L • Hemoglobin > 9 g/dL • Serum total bilirubin = 1.5 x ULN • ALT and AST = 3.0 x ULN (with or without liver metastases) • Serum creatinine = 1.5 x ULN 9. Written informed consent obtained according to local guidelines
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Patients who have received prior anticancer therapy with an FGFR inhibitor 2. Patients who have received > 1 prior line(s) of anticancer treatment for advanced (neoadjuvant/adjuvant therapy not considered one line as per inclusion criterion #4) or metastatic disease 3. Patients with uterine sarcomas, adenosarcoma, and malignant Mullerian tumors 4. Patients with isolated recurrences (vaginal, pelvic, or para-aortic) potentially curative with radiation therapy or surgery 5. Patients with known brain metastases 6. Patients with another primary malignancy within 3 years prior to starting study treatment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix 7. Patients who have participated in a prior anticancer investigational study = 30 days prior to enrollment, or = 5 half-lives of the anticancer investigational product, whichever is longer 8. Patients who have received the last administration of anticancer targeted small molecule therapy (e.g., sunitinib, sorafenib, pazopanib, axitinib, everolimus, temsirolimus, ridaforolimus) = 2 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy 9. Patients who have received the last administration of an anticancer monoclonal antibody, immunotherapy, hormonal therapy, or chemotherapy (except nitrosoureas and mitomycin- C) = 4 weeks prior to starting study drug or who have not recovered from the side effects of such therapy 10. Patients who have received the last administration of nitrosourea or mitomycin-C = 6 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy 11. Patients who have received radiotherapy = 4 weeks prior to starting study drug or who have not recovered from radiotherapy-related toxicities (note: palliative radiotherapy for bone lesions = 2 weeks prior to starting study drug is allowed) 12. Patients who have undergone major surgery (e.g., intra-thoracic, intra-abdominal, or intrapelvic) = 4 weeks prior to starting study drug or who have not recovered from side effects of such surgery 13. Patients with a history of pulmonary embolism or untreated deep venous thrombosis = 6 months prior to starting study drug 14. Impaired cardiac function or clinically significant cardiac diseases, including any of the following: see section 5.3 of protocol. 15. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of TKI258 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection) 16. Cirrhosis, chronic active hepatitis, or chronic persistent hepatitis 17. Known history of HIV infection (HIV testing is not mandatory) 18. Patients who are currently receiving prasugrel, clopidogrel, or full dose anticoagulation treatment with therapeutic doses of warfarin. However, treatment with low doses of warfarin (e.g., =2 mg/day) or locally accepted low doses of acetylsalicylic acid (up to 100 mg daily) to prevent cardiovascular events or strokes is allowed. 19. Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol 20. Pregnant or breast-feeding women 21. Women of child-bearing potential, who are
研究者
相似试验
进行中（未招募）
不适用
A trial investigating the efficacy of TKI258 in patients with cancer of the endometrium that has progressed after prior therapyEUCTR2011-000266-35-ESovartis Farmacéutica S.A80
进行中（未招募）
1 期
A trial investigating the efficacy of TKI258 in patients with cancer of the endometrium that has progressed after prior therapyAdvanced and/or metastatic endometrial carcinomaMedDRA version: 20.0 Level: PT Classification code 10014736 Term: Endometrial cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-000266-35-GBovartis Pharma Services53
进行中（未招募）
不适用
A phase II non-randomised, open-label, single-arm study to assess the efficacy, safety and tolerability of Nexavar ® (Sorafenib) monotherapy as third line therapy in patients with progressed ovarian epithelial or primary peritoneal cancer. - OCCASIONE1. progressed ovarian epithelial cancer2. primary peritoneal cancerMedDRA version: 9.1Level: LLTClassification code 10033128Term: Ovarian cancerEUCTR2008-002156-14-PLFUNDATION OF EXPERIMENTAL AND CLINICAL ONCOLOGY
进行中（未招募）
1 期
The study will determine if subjects are able to stop eltrombopag treatment while maintaining acceptable platelet levels after their disease has become resistant to treatment (refractory) or has a reoccurrence of symptoms after initial treatment with steroids (relapse)MedDRA version: 23.0Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem Organ Class: 100000004851MedDRA version: 22.1Level: LLTClassification code 10036735Term: Primary thrombocytopeniaSystem Organ Class: 100000004851immune thrombocytopeniaEUCTR2018-000452-18-ATovartis Pharma AG101
进行中（未招募）
1 期
The study will determine if subjects are able to stop eltrombopag treatment while maintaining acceptable platelet levels after their disease has become resistant to treatment (refractory) or has a reoccurrence of symptoms after initial treatment with steroids (relapse)MedDRA version: 20.1Level: LLTClassification code 10050245Term: Autoimmune thrombocytopeniaSystem Organ Class: 100000004851MedDRA version: 20.0Level: LLTClassification code 10036735Term: Primary thrombocytopeniaSystem Organ Class: 100000004851immune thrombocytopeniaEUCTR2018-000452-18-ESovartis Farmacéutica, S.A.101