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UNKNOWNPHASE1

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

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

NCT01219192•Protgen Ltd

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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)
+4 more criteria

Locations (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

August 1, 2010

Primary Completion Date

December 1, 2011

Completion Date

December 1, 2011

Last Updated

October 28, 2010

Enrollment

ESTIMATED participants

Conditions

Pancreatic Cancer

Interventions

M2ES

DRUG

M2ES

DRUG

M2ES

DRUG

M2ES 60mg

DRUG

Contacts

Long CHENG, master

CONTACT

8610629792458 chenglong.bj@gmail.com

Fei WU, master

CONTACT

8610629792458

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 28, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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