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PLD Combined With Ifosfamide in Advanced Soft Tissue Sarcoma
NCT03268772Phase 2
Key facts
- Status
- Unknown
- Start
- Apr 2015
- Primary completion
- Nov 2020
- Countries
- 1
- Sponsor
- Fudan University
- Modality
- DNA Intercalators/Alkylators
- Drugs
- doxorubicin
- Conditions
- soft tissue sarcoma (STS)
01
Overview
Phase 2, open-label, single-arm trial of doxorubicin in soft tissue sarcoma (STS), sponsored by Fudan University. Primary endpoint: Progression Free Survival at 6 months. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
PLD-IFO
Pegylated liposomal doxorubicin combined with ifosfamide
03
Who it enrols
Patients aged 18-70 with histologically confirmed advanced or metastatic STS, ECOG 0-2, and no prior chemotherapy. Excludes osteosarcoma, Ewing's sarcoma/PNET, GIST, rhabdomyosarcoma, and dermatofibrosarcoma protuberans.
04
Endpoints
Primary
Progression Free Survival
Secondary
Overall Response Rate
Overall Survival
Adverse Events
Biomarker Analysis
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