CTRI/2017/12/011026Other2 期
A Phase 2, Open-Label Randomized Trial Evaluating the Efficacy and Safetyof Two Dosages of Once Daily Oral CA-170 in Patients with Selected RelapsedAdvanced Tumors (ASIAD)
Aurigene Discovery Technologies Limited0 个研究点目标入组 62 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- Other
- 发起方
- 入组人数
- 62
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Males and females >= 18 years of age;
- •2.Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 (See Appendix A); In brief, this criterion requires that the patient either be fully active or at least should be able to carry out work of a light or sedentary nature.
- •3.Acceptable bone marrow and organ function at screening as described below:
- •a.ANC >= 1500/μL (without WBC growth factor support)
- •b.Platelet count >= 75,000/μL;
- •c.Hemoglobin >= 9 g/dL
- •d.Total Bilirubin<= 1.5 x ULN;
- •e.AST (SGOT) <= 3 x ULN (<= 5 Ã? ULN if known liver metastases)
- •f.ALT (SGPT) <= 3 x ULN (<= 5 Ã? ULN if known liver metastases)
- •g.Serum creatinine <= 2 mg/dL or a measured creatinine clearance >= 40 mL/min according to Cockcroft-Gault formula.
- •4.Ability to swallow and retain oral medications;
- •5.Negative serum pregnancy test in women of childbearing potential (WOCBP);
- •6.Women of childbearing potential and men who partner with such a woman of childbearing potential must agree to use one or more of highly effective method(s) for contraception (as defined in Section 8.3.4) for the duration of the study, i.e. through 28-day safety follow up visit;
- •7.Willing and able to provide written informed consent and comply with the requirements of the trial;
- •8.Evidence of measurable disease per RECIST, v1.1 or Revised Response Criteria for Malignant Lymphoma. Measurable disease is defined as a lesion that can be accurately measured in at least 1 dimension in solid tumors or 2 dimensions in Hodgkin Lymphoma with a minimum size of 10 mm (longest diameter to be recorded);
- •9.Trial participants with accessible tumors must agree to pre-treatment biopsies for biomarkers including PD-L1 testing, as required by the protocol, unless the biopsy is medically contraindicated or unsafe or the tumor is not accessible. (Note: PD-L1 status is not a requirement for study enrollment.) Patients must have archival specimen if a new pre-treatment biopsy is not being done because of inaccessibility of tumor, contraindication for biopsy or safety issues.
- •10.Patients with one of the following histologically confirmed advanced tumor types who have received 1-3 lines of prior therapy.
- •10a.Non-Squamous Non-Small Cell Lung Cancer (Non-Squamous NSCLC)
- •10b.Squamous Non-Small Cell Lung Cancer (Squamous NSCLC)
- •10c.Squamous Cell Cancer of Head & Neck (SCCHN)
- •10d.Microsatellite Instability-High (MSI-High) or Mismatch Repair Deficient (dMMR) Tumours (e.g. Colorectal Carcinoma, Gastric Carcinoma, Endometrial Carcinoma, Cholangiocarcinoma, etc.)
- •10e.Classical Hodgkin Lymphoma
- •Patients in 10d, in general, should already be known to have MSI-H / dMMR status at the time of screening. However, patients with unknown MSI status may also be screened (at designated central lab) by IHC for the absence of the protein products (MLH1, MSH2, MSH6 and PMS2) of the respective mismatch repair (MMR) genes. Those with known MSI-H / dMMR status by a previously done IHC or PCR will also be confirmed at designated central lab by IHC for the absence of at least one of the protein products (MLH1, MSH2, MSH6 and PMS2) before enrolment. Confirmation by central lab review is necessary before patient enrolment. The list of tumors with MSI-H / dMMR biomarker status is expanding and all solid tumors with literature support will be a
排除标准
- 未提供
研究者
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