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Aldoxorubicin Plus Ifosfamide/Mesna in Soft Tissue Sarcoma
NCT02235701Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2014
- Primary completion
- May 2018
- Countries
- 1
- Sponsor
- ImmunityBio, Inc.
- Modality
- Prodrugs/Conditional Activator Small Molecules
- Drugs
- aldoxorubicin
- Conditions
- soft tissue sarcoma (STS)
01
Overview
Phase 2, open-label trial of aldoxorubicin in soft tissue sarcoma (STS) (2 arms), sponsored by ImmunityBio, Inc. Primary endpoint: Number of Adverse Events in Participants up to 766 days. Started Sep 2014; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
170 mg/m2 aldoxorubicin
170 mg/m2 aldoxorubicin + ifosfamide/mesna
250 mg/m2 aldoxorubicin
250 mg/m2 aldoxorubicin + ifosfamide/mesna
03
Who it enrols
Patients aged 15-80 with histologically confirmed metastatic, locally advanced, or unresectable soft tissue sarcoma (including GIST after imatinib/sunitinib failure). Must have ECOG 0-2, adequate organ function, and no prior chemotherapy for metastatic disease (adjuvant allowed if >12 months recurrence-free).
04
Endpoints
Primary
Number of Adverse Events in Participants
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