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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Completed

CT.gov ID

NCT01260025

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

MTD and DLT of M2ES
Pharmacokinetics of M2ES

Condition or Disease	Intervention/Treatment	Phase
Tolerability Pharmacokinetics Endostatin	Drug: PEDylated Recombinant Human Endostatin	Phase 1

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Dose Escalation Study of Tolerability and Pharmacokinetics of PEDylated Recombinant Human Endostatin(M2ES)in the Treatment of Advanced Solid Tumor

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PEDylated Recombinant Human Endostatin PEDylated Recombinant Human Endostatin	Drug: PEDylated Recombinant Human Endostatin The initial dose of PEDylated Recombinant Human Endostatin (M2ES) will be 7.5mg/m2.Dose Escalation to a next higher level will occur when 3 patients in the same dose level complete 28 days of continuous treatment without experiencing a dose-limiting toxicity. Other Names: M2ES

Arm

Intervention/Treatment

Experimental: PEDylated Recombinant Human Endostatin

PEDylated Recombinant Human Endostatin

Drug: PEDylated Recombinant Human Endostatin

The initial dose of PEDylated Recombinant Human Endostatin (M2ES) will be 7.5mg/m2.Dose Escalation to a next higher level will occur when 3 patients in the same dose level complete 28 days of continuous treatment without experiencing a dose-limiting toxicity.

Other Names:

M2ES

Outcome Measures

Primary Outcome Measures

Maxinum tolerated dose of M2ES [one month]
To assess the adverse events

Secondary Outcome Measures

Tumor response rate [one month]
To assess the tumor response rate of M2ES in patients with solid, malignant tumours
Pharmacokinetic effect [one month]
Pharmacokinetic effect of M2ES in patients with solid, malignant tumours
DLT of M2ES [one month]
To assess the adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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