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Pilot Phase 2 Study to Investigate the Preliminary Efficacy and Safety of INNO-206 in Advanced Pancreatic Cancer

NCT01580397 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-06-06

Study results available
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Summary

Patients with metastatic, locally advanced, or unresectable pancreatic ductal carcinomas (PDA) who have failed prior chemotherapy with gemcitabine regimens have an extremely poor prognosis with progression-free survival of around 13 weeks and median overall survival of approximately 20 weeks after second line chemotherapy. Recent studies suggest that albumin may be preferentially concentrated in pancreatic cancers that appear to be starved for this protein. Thus, any molecule attached to albumin would also collect inside the tumor. Based on its postulated mechanism of action, INNO-206 may improve the activity of doxorubicin without increasing its toxicity, as has been demonstrated in animal studies, and induce enhanced anti-tumor efficacy.

Conditions

Interventions

DRUG

INNO-206

INNO-206 at a total dose of 350 mg/m2 (260 mg/m2 doxorubicin equivalent) will be administered as a 30 minute IV infusion every 21 days.

Sponsors & Collaborators

  • ImmunityBio, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Von Hoff, MD, FACP · Translational Genomics Research Institute

  • Daniel Levitt, MD, PhD · CytRx

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-16
Primary Completion
2013-05-13
Completion
2013-07-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01580397 on ClinicalTrials.gov