CTRI/2016/05/006953尚未招募1 期
A Phase-I/II, Open Label, Dose-Finding Study of DO-013 Alone and In Combination with Gemcitabine Among Patients with Advanced Carcinoma of Pancreas
Dr Arun Maseeh Study Director Cadila Pharmaceuticals Ltd0 个研究点目标入组 38 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
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
- •Histologically or cytologically confirmed malignancy of exocrine pancreas with evidence of locally advanced (non-resectable stage- II or III) ormetastatic disease (stage-IV), with following criteria:
- •a)Stage-I and stage-II (test-arm-1): Patients who have been refractory to standard chemotherapy (including gemcitabine-based regimens) or any other therapy or for whom no standard therapy exists.
- •b.Stage-II (test-arm-2): Patients who may have received previous chemotherapy or radiation therapy, but must be amenable for a gemcitabine treatment according to the discretion of investigator.
- •Male and female patients with the age of 18 years or above.
- •Life expectancy of at least 12 weeks
- •Eastern Cooperative Oncology Group (ECOG) performance status: <=2
- •Patient with at least one uni-dimensionally measurable lesion by computed
- •tomography (CT) scan as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1)32
- •All acute toxic effects (excluding alopecia) of any prior therapy (including surgery,radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) â?? Common Terminology Criteria for Adverse Events (CTCAE, v4.0)29 -Grades <=1.
- •Patient with biliary or gastro-duodenal obstruction must have drainage or bypass prior to starting chemotherapy.
- •Patient with adequate hepatic function defined as alkaline phosphatase (ALP), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) <=3 x upper limit of reference range (ULN), and total bilirubin <=2.0 x ULN unless liver involvement by the tumor, in which case the transaminase levels could be up to 5 x ULN.
- •Patient with adequate renal function defined as serum creatinine (Scr) <=1.5 ULN or calculated 24 hours creatinine clearance (CLCR) >=50 ml/min.
- •Patient with adequate hematological function defined as hemoglobin (Hb) >=9.0 mg/dL, absolute neutrophil count (ANC) >=1.5 x 109/L and platelet count >=1 x 1011/L.
- •Patient with amylase/lipase <=1.5 times ULN.
- •Documented negative test for human immuno virus (HIV-1/2).
- •Negative serum pregnancy test for female patient of child-bearing potential within 14 days of starting treatment. Female patient of child bearing potential or sexually active male patient with partners of childbearing potential must use effective birth control measures (e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterine contraceptive devices, or sterilization) during treatment and at least 6 months after the last dose of the study treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately. If a female partner becomes pregnant during the course of the study, the investigator should be informed immediately.
- •Fasting serum cholesterol <=300 mg/dL OR <=7.75 mmol/L and fasting triglycerides <=2.5 x ULN.
- •Note: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
- •Screening electrocardiogram (ECG) with a time from ECG-Q wave to the end of the T wave corresponding to electrical systole [QT] corrected for heart rate (QTc) <450 msec.
排除标准
- •Subjects who refuse to give written informed consent.
- •Patients with known history of allergy or hypersensitivity to investigational drug, gemcitabine or their formulation ingredients, or to other intravenously or intradermally administered human proteins/peptides/antibodies/whole cell lysates.
- •Pregnant or lactating female patient.
- •Known history or presence of symptomatic metastatic brain or meningeal tumors.
- •No active pancreatitis, defined as clinically symptomatic hyperamylasemia and/or hyperlipasemia, and symptomatic cholelithiasis.
- •Chemotherapy or radiation therapy within 4 weeks of the administration of study treatment for patients under screening.
- •Previous gemcitabine (for test-arm-2 only during stage-II) given concurrently as radiosensitizers to radiotherapy in adjuvant intention if given within 6 months from the start of study treatment.
- •Patients with previous or concurrent malignancy except for inactive non-melanoma skin cancer and/or in situ carcinoma of the cervix, or other solid tumor treated curatively and without evidence of recurrence within the last 3 years prior to study entry.
研究者
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