Study With M2ES and Gemcitabine for Patients With Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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Phase I trail will be conducted to evaluate the safety of M2ES in combination with gemcitabine in locally advanced or metastatic pancreatic cancer.

Detailed Description
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Phase I trail will be conducted to determine the MTD and safety of M2ES(administered intravenous infusion on Days 1,8,15,21of a 28-day cycle) in combination with gemcitabine (1000 m/m2). Gemcitabine will be administered as an intravenous infusion on Days 1, 8, and 15 of each 28-day cycle,at the same time determine the safety and efficiency of this combined regime.

Official Title
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Phase I Study of M2ES Combined Gemcitabine in Patients With Advanced Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: M2ES 7.5mg
* Drug: M2ES 15mg
* Drug: M2ES 30mg
* Drug: M2ES 45mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients had histologically or cytologically confirmed pancreatic adenocarcinoma that was not amenable to potentially curative surgery. No prior chemotherapy was allowed. Prior radiation therapy was allowed provided that the only sites of measurable disease were not located within the radiation port. 18 to 60 years of age Karnofsky performance status (KPS) of 60-100 points Unidimensionally measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria Adequate hematologic, renal, and hepatic function was required as deWned by the following: WBC ≥4×109/L, absolute neutrophil count ≥ 1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥ 9g/dL, total bilirubin ≤2 upper limit of normal [ULN],AST ≤ 1.5 ULN, or ≤ 3 ULN if there was evidence of liver metastases; alkaline phosphatase ≤ 1.5 ULN, or ≤ 3 ULN if there was evidence of liver Metastases; creatinine clearance ≥50 mL/min. life expectancy of at least 12 weeks. All patients provided written informed consent according to federal and institutional guidelines. Exclusion Criteria: patients had clinically apparent CNS disease ( primary brain tumors, tumor related apoplexy, CNS metastases, carcinomatous meningitis.) another active malignancy, or any history of other malignancy within the past 5 years except for nonmelanoma skin cancer and carcinoma in situ of the cervix. more than 4 weeks intervals between the last administration of the targeted therapy regimen and study entry. radiation therapy have not been completed 4 weeks before enrollment. major surgery within the prior 4 weeks; participating any clinical trial within the prior 4 weeks; Pregnant or lactating women. tumor involvement of major blood vessels uncontrolled intercurrent illness as following: prior or ongoing uncontrolled hypertension;angina pectoris; congestive cardiac failure; myocardial ischemia, infarction, uncompensated coronary artery disease within the past 6 months; Uncontrolled arrhythmia; Uncontrolled diabetes mellitus; Uncontrolled infection. chronic renal disease. urine protein ≥ 500 mg in 24 hours; prior history of gastrointestinal bleeding, hemoptysis, bleeding diathesis. pulmonary embolus, or deep venous thrombosis ECG: QTC ≥ 480 ms Patients on therapeutic doses of heparin or antiplatelet agents. Patients who received thrombolytic agents or who required full-dose anticoagulation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: M2ES-A<br> | Drug: M2ES 7.5mg<br>* M2ES Dosage：7.5mg/m2<br>* Other names: M2ES;|
| Experimental: M2ES-B<br> | Drug: M2ES 15mg<br>* M2ES Dosage：15mg/m2<br>* Other names: M2ES;|
| Experimental: M2ES-C<br> | Drug: M2ES 30mg<br>* M2ES Dosage：30mg/m2<br>* Other names: M2ES;|
| Experimental: M2ES-D<br> | Drug: M2ES 45mg<br>* M2ES Dosage：45mg/m2<br>* Other names: M2ES;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerant dose |  | 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate |  | 8 weeks |