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Study With M2ES and Gemcitabine for Patients With Advanced Pancreatic Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE1

Study With M2ES and Gemcitabine for Patients With Advanced Pancreatic Cancer

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

NCT01218880•Protgen Ltd

Summary

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

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. patients had histologically or cytologically confirmed pancreatic adenocarcinoma that was not amenable to potentially curative surgery.
•2. No prior chemotherapy was allowed.
•3. Prior radiation therapy was allowed provided that the only sites of measurable disease were not located within the radiation port.
•4. 18 to 60 years of age
•5. Karnofsky performance status (KPS) of 60-100 points
•6. Unidimensionally 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 ≥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.
•8. life expectancy of at least 12 weeks.
•9. All patients provided written informed consent according to federal and institutional guidelines.

Exclusion Criteria

•1. patients had clinically apparent CNS disease ( primary brain tumors, tumor related apoplexy, CNS metastases, 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 4 weeks intervals between the last administration of the targeted therapy regimen and study entry.
•4. radiation therapy have not been completed 4 weeks before enrollment.
•5. major surgery within the prior 4 weeks;
•6. participating any clinical trial within the prior 4 weeks;
•7. Pregnant or lactating women.
•8. tumor involvement of major blood vessels
•9. 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.
•10. chronic renal disease.
+6 more criteria

Locations (1)

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

June 1, 2010

Primary Completion Date

July 1, 2011

Completion Date

December 1, 2011

Last Updated

October 19, 2010

Enrollment

ESTIMATED participants

Conditions

Pancreatic Cancer

Interventions

M2ES 7.5mg

DRUG

M2ES 15mg

DRUG

M2ES 30mg

DRUG

M2ES 45mg

DRUG

Contacts

Zhaosheng Li, MD

CONTACT

8621-81873241 zhsli@81890.net

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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 19, 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 With M2ES and Gemcitabine for Patients With Advanced Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

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