Study of M2ES in Patients With Advanced Pancreatic Cancer After Gemcitabine Treatment Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability and determine the recommended dosing for the treatment in patients with advanced pancreatic cancer after fist-line Gemcitabine treatment failure.

Detailed Description
-----------------
To evaluate the safety and tolerability and determine the recommended dosing for the treatment in patients with advanced pancreatic cancer after fist-line Gemcitabine treatment failure.We star with the dose M2ES 15mg,then escalate to 30mg 45mg 60mg,to find the recommended dose in clinic practise.

Official Title
-----------------
Phase I Study of M2ES in Patients With Advanced Pancreatic Cancer After Gemcitabine Treatment Failure

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: M2ES
* Drug: M2ES
* Drug: M2ES
* Drug: M2ES 60mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically or cytologically confirmed pancreatic adenocarcinoma that was not amenable to potentially curative surgery. All patients must have developed progressive disease (PD) while receiving or within 6 months after discontinuing palliative gemcitabine-based chemotherapy Prior radiation therapy was allowed provided that the only sites of measurable disease were not located within the radiation port. 18 years of age or older Karnofsky performance status (KPS) of 60-100 points 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 ≥3.5×109/L, absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥100 × 109/L, hemoglobin≥9g/dL, total bilirubin ≤2.5 upper limit of normal [ULN],AST≤2.5 ULN, or≤5 ULN if there was evidence of liver metastases;alkaline phosphatase≤ 2.5 ULN, or≤ 5 ULN if there was evidence of liver Metastases creatinine clearance≤50 mL/min, life expectancy of at least 12 weeks Exclusion Criteria: patients had clinically apparent CNS metastases or 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 3 weeks intervals between the last administration of the prior chemotherapy regimen and study entry more than 4 weeks intervals between the last administration of the targeted therapy regimen and study entry major surgery within the prior 6 weeks; Pregnant or lactating women tumor involvement of major blood vessels uncontrolled intercurrent illness A history of myocardial infarction or stroke within the last 6 months, uncontrolled hypertension, unstable angina clinically significant cardiac disease (eg, congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication, or myocardial infarction) urine protein ≥ 500 mg in 24 hours; evidence of bleeding diathesis or coagulopathy Patients on therapeutic doses of low-molecular weight heparin Patients who received thrombolytic agents within the previous month or who required full-dose anticoagulation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 15mg<br> | Drug: M2ES<br>* M2ES IV D1,8,15,21 every 28 days a cycle<br>* Other names: M2ES 15mg intervention;|
| Experimental: M2ES 30mg<br> | Drug: M2ES<br>* M2ES IV D1,8,15,21, every 28days a cyce.<br>* Other names: M2ES 30mg intervention;|
| Experimental: M2ES 45mg<br> | Drug: M2ES<br>* M2ES 45mg IV D1,8,15,22 28days a cycle<br>* Other names: M2ES 45mg intervention;|
| Experimental: M2ES 60mg<br> | Drug: M2ES 60mg<br>* M2ES 60mg IV D1,8,15,22 every 28days a cycle<br>* Other names: M2ES 60mg intervention;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MDT | The maximum tolerable dosage | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | progress free survival | 4 months |