Status:
COMPLETED
Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor
Lead Sponsor:
Sun Yat-sen University
Conditions:
Tolerability
Pharmacokinetics
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
1. MTD and DLT of M2ES 2. Pharmacokinetics of M2ES
Detailed Description
Patients received infusion of M2ES for 120 minutes weekly（d1,d8,d15）by calculated pump and underwent evaluation of vital signs including blood pressure, pulse, respiratory rate, and temperature before...
Eligibility Criteria
Inclusion
- Age between 18 and 65 years;Genders eligible for study: both;
- Histologic diagnosis of solid malignancies ;
- Performance status of 0 or 1;
- Tumor not amenable to standard curative or palliative therapy;
- life expectancy beyond 3 months;
- Ability to give signed informed consent
Exclusion
- Pregnancy or lactation;
- Had a history of brain metastasis or a primary brain tumor;
- An active, potentially severe autoimmune disease;
- Serum creatinine ≥1.5mg/dl or a calculated creatinine clearance \<60ml/min; WBC count \< 2.0×109/L，hemoglobin \< 90g/L，and platelet count \< 100×109/L; Total bilirubin value \< 2.0 times the upper limit of normal (ULN), ALT level \< 2.0 times ULN, AST \< 2.0 times ULN;
- Positive of anti-HIV antibodies;
- An active infection;
- had received chemotherapy or immunotherapy within the prior 4 weeks before study entry
- Participation in a clinical study during the last 28 days
- QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01260025
Start Date
September 1 2009
End Date
January 1 2011
Last Update
February 16 2012
Active Locations (1)
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1
Sun Yat-Sen University
Guangzhou, Guangdong, China, 510060