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INNO-206 vs Doxorubicin in Advanced Soft Tissue Sarcoma

NCT01514188Phase 2

Key facts

Status: Completed
Start: Jan 2012
Primary completion: Apr 2014
Countries: 7
Sponsor: ImmunityBio, Inc.
Modality: Prodrugs/Conditional Activator Small Molecules

Drugs: aldoxorubicin
Conditions: soft tissue sarcoma (STS)

Overview

Phase 2, randomised, open-label trial of aldoxorubicin in soft tissue sarcoma (STS) (2 arms), sponsored by ImmunityBio, Inc. Primary endpoint: Progression-free Survival at 24 months. Started Jan 2012; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

INNO-206
INNO-206 (Aldoxorubicin) 350 mg/m2 IV q3w
Doxorubicin
Doxorubicin 75 mg/m2 IV q3w

Who it enrols

Patients with metastatic, locally advanced, or unresectable intermediate or high grade soft tissue sarcoma who have not received prior chemotherapy for advanced disease (adjuvant/neoadjuvant allowed if >12 months recurrence-free).

Endpoints

Primary

Progression-free Survival24 months

Secondary

Overall Survival35 months
Progression-free Survival at 4 and 6 Months6 months
Objective Overall Response Rate24 months
Number of Participants With Treatment-related ToxicitiesUp to 136 days

Results

Primary endpoints met

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