Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor

Sun Yat-sen University

Status and phase: Completed; Phase 1

Conditions: Endostatin; Tolerability; Pharmacokinetics

Treatments: Drug: PEDylated Recombinant Human Endostatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01260025

2009L01132

Details and patient eligibility

About

1. MTD and DLT of M2ES
2. Pharmacokinetics of M2ES

Full 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 treatment, at intervals during infusion, and hourly for 6 hours after infusion. After infusion, patients underwent serial pharmacokinetic sampling. All patients were seen weekly during the study therapy and follow-up and underwent evaluation with physical examination including ECOG performance status, vital signs, and laboratory evaluation with complete blood count with manual differential, chemistry evaluation, prothrombin time/partial thromboplastin time, and urinalysis.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

PEDylated Recombinant Human Endostatin

Experimental group

Description:

PEDylated Recombinant Human Endostatin

Treatment:

Drug: PEDylated Recombinant Human Endostatin