$0.00
Shopping Cart
Facebook-f Instagram
DONATE
Donate

Clinical Trial Record

Return to Clinical Trials

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

2010-08

2011-12

2011-12

24

Study Overview

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

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.

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.

  • Pancreatic Cancer
  • DRUG: M2ES
  • DRUG: M2ES
  • DRUG: M2ES
  • DRUG: M2ES 60mg
  • M2ES2010-2

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2010-10-08  

N/A  

2010-10-27  

2010-10-08  

N/A  

2010-10-28  

2010-10-13  

N/A  

2010-10  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: M2ES 15mg

DRUG: M2ES

  • M2ES IV D1,8,15,21 every 28 days a cycle
EXPERIMENTAL: M2ES 30mg

DRUG: M2ES

  • M2ES IV D1,8,15,21, every 28days a cyce.
EXPERIMENTAL: M2ES 45mg

DRUG: M2ES

  • M2ES 45mg IV D1,8,15,22 28days a cycle
EXPERIMENTAL: M2ES 60mg

DRUG: M2ES 60mg

  • M2ES 60mg IV D1,8,15,22 every 28days a cycle
Primary Outcome MeasuresMeasure DescriptionTime Frame
MDTThe maximum tolerable dosage3 weeks
Secondary Outcome MeasuresMeasure DescriptionTime Frame
PFSprogress free survival4 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Long CHENG, master

Phone Number: 8610629792458

Email: chenglong.bj@gmail.com

Study Contact Backup

Name: Fei WU, master

Phone Number: 8610629792458

Email:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. histologically or cytologically confirmed pancreatic adenocarcinoma that was not amenable to potentially curative surgery. 2. All patients must have developed progressive disease (PD) while receiving or within 6 months after discontinuing palliative gemcitabine-based chemotherapy 3. Prior radiation therapy was allowed provided that the only sites of measurable disease were not located within the radiation port. 4. 18 years of age or older 5. Karnofsky performance status (KPS) of 60-100 points 6. measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria 7. 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, 8. life expectancy of at least 12 weeks
    Exclusion Criteria:
    1. patients had clinically apparent CNS metastases or carcinomatous meningitis 2. 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 3. more than 3 weeks intervals between the last administration of the prior chemotherapy regimen and study entry 4. more than 4 weeks intervals between the last administration of the targeted therapy regimen and study entry 5. major surgery within the prior 6 weeks; 6. Pregnant or lactating women 7. tumor involvement of major blood vessels 8. uncontrolled intercurrent illness 9. A history of myocardial infarction or stroke within the last 6 months, uncontrolled hypertension, unstable angina 10. clinically significant cardiac disease (eg, congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication, or myocardial infarction) 11. urine protein ≥ 500 mg in 24 hours; 12. evidence of bleeding diathesis or coagulopathy 13. Patients on therapeutic doses of low-molecular weight heparin 14. Patients who received thrombolytic agents within the previous month or who required full-dose anticoagulation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Shunchang JIAO, MD, Chinese PLA General Hospital

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

    Treat yourself

    Let Us Take Care Of You

    BOOK AN APPOINTMENT ⟶
    footer logo

    About

    Events

    Fundraising

    Contact Us

    Facebook-f Instagram

    NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.

    The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.

    Copyright © 2025 – National Pancreatic Cancer Foundation | All Rights Reserved

    Make-A-Will Month

    Snag 6508be92
    Learn More
    Donate Now Online
    Other Ways to Donate