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Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma

NCT01514188 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2024-05-29

Study results available
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Summary

This is a phase 2b, randomized, open-label, prospective, multicenter study comparing treatment with INNO 206 to doxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy except potentially as adjuvant or neoadjuvant chemotherapy, and no evidence of tumor recurrence has occurred for at least 12 months.

Conditions

  • Metastatic Soft Tissue Sarcoma
  • Locally Advanced Soft Tissue Sarcoma
  • Unresectable Soft Tissue Sarcoma

Interventions

DRUG

INNO-206

INNO-206 administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 6 consecutive cycles

DRUG

Doxorubicin

Doxorubicin administered at 75 mg/m2 for up to 6 consecutive cycles.

Sponsors & Collaborators

  • ImmunityBio, Inc.

    lead INDUSTRY

Principal Investigators

  • Sant Chawla, M.D. · Sarcoma Oncology Center

  • Daniel Levitt, M.D., Ph.D. · CytRx

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-11
Primary Completion
2014-04-09
Completion
2014-12-15

Countries

  • United States
  • Australia
  • Hungary
  • India
  • Romania
  • Russia
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01514188 on ClinicalTrials.gov