KCT0003543已完成未知
An Open Label, Single-Arm, Multi-center Phase II Study to Evaluate the safety and Efficacy of Herzuma® in Combination with Paclitaxel in HER2-positive Recurrent/Metastatic Urothelial Carcinoma
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 27
研究概览
简要总结
Twenty-six patients were evaluated via primary endpoint analysis. The ORR was 48.1% (1 complete and 12 partial responses) and the duration of response was 6.9 months [95% con?dence interval (CI) 4.4-9.3 months]. With a median follow-up of 10.5 months, the median PFS and OS were 8.4 months (95% CI 6.2-8.8 months) and 13.5 months (95% CI 9.8 months-not reached), respectively. The most common treatment-related adverse event (TRAE) of any grade was peripheral neuropathy (88.9%). The most common grade 3/4 TRAEs were neutropenia (25.9%), thrombocytopenia (7.4%), and anemia (7.4%). In conclusion, trastuzumab-pkrb plus paclitaxel demonstrates promising ef?cacy with manageable toxicity pro?les in patients with HER2-positive recurrent or metastatic UC.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1)?Have histologically proven urothelial carcinoma.
- •2)?Be = 20 years of age on the day of signing the informed consent.
- •3)?Have ECOG performance status 0-1.
- •4)?Have previously received palliative 1st line platinum based chemotherapy. (2nd or more line, prior immune checkpoint inhibitor experienced patients were allowed.)
- •5)?Measurable lesion by RECIST1.1
- •6)?HER2 IHC 3+ (2+ patients can not be enrolled)
- •*HER2 definition http://ascopubs.org/doi/full/10.1200/JCO.2013.50.9984
- •7)?Have adequate major organ functions as demonstrated by the following blood counts at the time of screening:
- •-Adequate bone marrow function as defined by absolute neutrophil count (ANC) = 1,000 /mm3, platelet count = 75,000 /mm3 and hemoglobin = 9 g/dL.
- •-Adequate renal function, with serum creatinine = 1.5 x upper limit of normal (ULN).
- •-Adequate hepatic function with serum total bilirubin = 1.5 x ULN, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 2.5 x ULN.
- •?Baseline LVEF >50%.
- •8)?Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 2 weeks prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •9)?Female subjects of childbearing potential must be willing to use an adequate method of contraception.
- •?Male subjects of childbearing potential must agree to use an adequate method of contraception.
- •10)?Be willing and able to provide written informed consent for the trial
排除标准
- •1)?Has received prior therapy with anti HER2 therapy or paclitaxel
- •2)?Has a history of myocardial infarction within 6 months prior to the first dose of study treatment, and other clinically significant heart disease. (e.g., unstable angina, congestive heart failure or uncontrolled hypertension).
- •3)?Has a known additional malignancy that progressed or required active treatment within 5 years except curatively treated non-melanoma skin cancer or carcinoma in situ (e.g., of cervix, breast, prostate).
- •4,5)?Has received prior anti-cancer mAb, chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of trial treatment or who has not recovered from adverse events to grade =2 due to previously administered treatments.
- •6)?Has an active infection requiring systemic antibiotics therapy.
- •7)?Has a history of severe hypersensitivity to antibody products.
- •8)?Has undergone major surgery other than diagnostic surgery (e.g., surgery done to obtain a biopsy for diagnosis without removal of an organ) within 4 weeks prior to the first dose of study treatment.
- •9) females who are pregnant or breastfeeding
- •10)?Has medical or psychiatric conditions that compromise the patient's ability to give informed consent or to complete the protocol or a history of non-compliance.
- •11)?Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
研究者
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