A multicentric, open label, single arm study to evaluate the safety and efficacy of INTP26(trastuzumab biosimilar) in patients with HER2-overexpressing breast (early or metastatic) cancer or metastatic gastric cancer
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 21
- 主要终点
- Safety of INTP26 in patients with HER2-overexpressing breast (early or metastatic) cancer or metastatic gastric cancer.
研究概览
简要总结
Breast cancer is one of the most occurring cancers globally and in India as well, with incidence rate of 25.2% for the world and 27% for India. Among all breast cancer patients, human epidermal growth factor receptor 2 (HER2) overexpression or amplification occurs in approximately 20% to 25% of patients and is associated with aggressive disease and decreased survival. Gastric cancer is the second-most common cancer among men and third-most among women in Asia and worldwide. Trastuzumab has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumor cells that overexpress HER2. Additionally, trastuzumab is a potent mediator of antibody-dependent cell-mediated cytotoxicity (ADCC). In vitro, trastuzumab-mediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2. Intas has planned this Phase IV, non-comparative study to assess the safety and efficacy of INTP26 in patients with HER2-overexpressing breast (early and metastatic) and metastatic gastric cancer. This study fulfils the recommendation received from DCGI along with the marketing approval. This is a single arm, multicenter, Phase IV clinical trial. This will be a non-randomized study. Eligible patients will receive INTP26 for a total of 6 cycles (3 weekly regimen) or 18 cycles (weekly regimen). Approximately 200 patients will be included in the study assuming that it will be sufficient to meet the study objective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults ≥18 years old.
- •HER2-positive metastatic breast cancer (patients either previously treated or not previously treated for their metastatic disease), OR HER2-positive early breast cancer, OR HER2-positive metastatic adenocarcinoma of stomach or gastroesophageal junction adenocarcinoma who have not received prior anti-cancer treatment for their metastatic disease Note: HER2-positive is defined as: o Immunohistochemistry (IHC) score of 3+ (IHC score of 2+ will be considered if FISH test is positive for HER2 receptor) or Fluorescence in situ hybridization (FISH) test positive for HER2 receptor.
- •In case of early breast cancer, eligible patients receiving neoadjuvant or adjuvant therapy will be eligible.
- •Patients who have received trastuzumab in neoadjuvant or adjuvant setting will be allowed for adjuvant / metastatic setting in the study.
- •Patient should be eligible for trastuzumab treatment as per the approved prescribing information of the product.
- •At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) criteria Note: Measurable lesion criteria is not applicable for patients eligible for adjuvant therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
- •Normal left ventricular ejection fraction as per ECHO.
- •Understands the content of the protocol (including use of acceptable contraception during the study and until 6 months after the last dose of Trastuzumab), willing to provide informed consent and comply with protocol requirements.
排除标准
- •For females, a positive pregnancy test at screening or women who are lactating.
- •Males or WOCBP not willing to follow appropriate contraceptive measures during the course of study.
- •Known to have tested positive for HIV, HCV or HBsAg.
- •History of hypersensitivity to trastuzumab
- •Currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug trial(s), or patient is receiving another investigational agent(s).
- •History of substance abuse, including chronic alcoholism.
- •Life expectancy of less than 12 months.
- •Patients with NYHA Grade II (or more severe) congestive heart failure, clinically significant cardiac diseases (like, unstable angina pectoris, angina pectoris requiring treatment, myocardial infarction, valvular disease, cardiac arrhythmia) , cerebral infarction or transient ischemic attacks.
- •Uncontrolled hypertension even with treatment (systolic blood pressure [BP] >140 or diastolic BP >90mm Hg) or uncontrolled cardiac arrhythmias even with treatment (Patients with hypertension or arrhythmia controlled by therapies are eligible).
- •History of renal, hepatic, lung, immunological or haematological diseases that may affect patient safety as per the investigator.
- •Patients having active severe infections e.g., tuberculosis, sepsis and opportunistic infections.
- •Patients with brain metastasis.
- •Any of the following abnormal investigational values a.
- •General: Any laboratory abnormality, which, in the opinion of the Investigator, would prevent the patient from completing the study or interfere with the interpretation of the study results.
- •Liver transaminases: i.
- •Serum aspartate aminotransferase (AST; serum glutamateoxaloacetic transaminase [SGOT]) ≥2 × upper limits of normal [ULN]; ii.
- •Serum alanine aminotransferase (ALT; serum glutamate-pyruvate transaminase [SGPT]) ≥2.0 × ULN Alkaline phosphatase and bilirubin ≥1.5 × ULN (isolated bilirubin ≥1.5ULN is acceptable if bilirubin is fractionated and direct bilirubin 35%).
结局指标
主要结局
Safety of INTP26 in patients with HER2-overexpressing breast (early or metastatic) cancer or metastatic gastric cancer.
时间窗: Throught the study
次要结局
- Efficacy of INTP26 in patients with HER2-overexpressing breast (early or metastatic) cancer or metastatic gastric cancer.(Screening, and at 6, 12 and)