Pancreatic Cancer
Conditions
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.
Interventions
Sponsors
Protgen Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MDT | 3 weeks | The maximum tolerable dosage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 4 months | progress free survival |
Countries
China
Contacts
Primary ContactLong CHENG, master
Backup ContactFei WU, master
Outcome results
None listed