Study of M2ES in Patients With Advanced Pancreatic Cancer After Gemcitabine Treatment Failure
NCT ID: NCT01219192
Last Updated: 2010-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
24 participants
INTERVENTIONAL
2010-08-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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M2ES 15mg
M2ES
M2ES IV D1,8,15,21 every 28 days a cycle
M2ES 30mg
M2ES
M2ES IV D1,8,15,21, every 28days a cyce.
M2ES 45mg
M2ES
M2ES 45mg IV D1,8,15,22 28days a cycle
M2ES 60mg
M2ES 60mg
M2ES 60mg IV D1,8,15,22 every 28days a cycle
Interventions
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M2ES
M2ES IV D1,8,15,21 every 28 days a cycle
M2ES
M2ES IV D1,8,15,21, every 28days a cyce.
M2ES
M2ES 45mg IV D1,8,15,22 28days a cycle
M2ES 60mg
M2ES 60mg IV D1,8,15,22 every 28days a cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Protgen Ltd
INDUSTRY
Responsible Party
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Protgen Ltd
Principal Investigators
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Shunchang JIAO, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Fei WU, master
Role: CONTACT
Phone: 8610629792458
Facility Contacts
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Jihui HAO, MD
Role: primary
Other Identifiers
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M2ES2010-2
Identifier Type: -
Identifier Source: org_study_id