A Study of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma

Simcere

Status and phase: Unknown; Phase 2

Conditions: Osteosarcoma

Treatments: Drug: Endostar; Drug: Chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01002092

SIM-65

Details and patient eligibility

About

Purpose: This study will assess the safety and efficacy of Endostar combined with chemotherapy in osteosarcoma patients.

Enrollment: 160 estimated patients

Sex: All

Ages: 12 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with histologically confirmed osteosarcoma, who have no evidence of metastasis
• At least one measurable lesion
• Life expectancy > 3 months
• ECOG performance status 0-2
• Adequate hematologic, cardiac, renal, and hepatic function
• Patients with prior chemotherapy should have at least 4 weeks clearance period before entering this study

Exclusion criteria

• Evidence of metastasis
• Serious infection
• Evidence of bleeding diathesis
• Significant cardiovascular disease
• Pregnant or lactating woman
• Allergic to E.coli preparation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Chemotherapy

Active Comparator group

Treatment:

Drug: Chemotherapy

Endostar plus Chemotherapy

Experimental group

Treatment:

Drug: Chemotherapy

Drug: Endostar