Dose Escalation and PK Study of M2ES in Subjects With Advanced Solid Tumors

Protgen

Status and phase: Unknown; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: M2ES 60mg; Drug: M2ES 15mg; Drug: M2ES 30mg; Drug: M2ES 7.5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01226030

PG-2008-2

Details and patient eligibility

About

This study is dose-escalation open-label study to determine the MTD of M2ES in Subjects With Advanced Solid Tumors the recommended Phase II dose.The recommended dose and regimen of M2ES will be selected to perform the pharmacokinetic study profiles.

Full description

This study is a Phase I dose-escalation open-label study to determine the MTD of M2ES in Subjects With Advanced Solid Tumors the recommended Phase II dose.The recommended dose and regimen of M2ES will be selected to perform the pharmacokinetic study profiles.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 to 60 years of age
2. patients had histologically or cytologically confirmed solid tumors that was refractory to standard therapy.
3. life expectancy of at least 3 months.
4. ECOGPS ≤ 1
5. Adequate hematologic, renal, and hepatic function was required as determined by the following: WBC ≥4×109/L, absolute neutrophil count ≥ 1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥ 9g/dL, total bilirubin ≤1.5 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.

Exclusion criteria

1. Pregnant and latent women, no contraception for women of childbearing age
2. Have taken other treatments
3. Be allergic to endostatin and other ingredient
4. Gastrointestinal Hemorrhage
5. Have Participated any clinical trail during the last 4 week
6. ECG: QTC ≥ 480 ms
7. patients had clinically apparent CNS disease ( primary brain tumors, tumor related apoplexy, CNS metastases, carcinomatous meningitis.)
8. Cardiovascular and mental disease
9. HIV-1 infected
10. HBV, HBV infected ,Hepatitis B surface antigen positive
11. Patients on therapeutic doses of heparin or antiplatelet agents.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

24 participants in 4 patient groups

M2ES 7.5mg

Experimental group

Description:

M2ES 7.5mg

Treatment:

Drug: M2ES 7.5mg

M2ES 15mg

Experimental group

Description:

M2ES 15mg

Treatment:

Drug: M2ES 15mg

M2ES 30mg

Experimental group

Description:

M2ES 30mg

Treatment:

Drug: M2ES 30mg

M2ES 60mg

Experimental group

Description:

M2ES 60mg

Treatment:

Drug: M2ES 60mg