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A Phase 1 Study of Safety and Bioactivity With FG-3019 in Combination With Gemcitabine and Erlotinib for Subjects With Locally Advanced or Metastatic Pancreatic Cancer

NCT01181245 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-08-06

No results posted yet for this study

Summary

Objectives

* Primary: To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinib
* Secondary: To evaluate the efficacy and pharmacokinetics of FG-3019 in combination with gemcitabine and erlotinib

Conditions

  • Locally Advanced or Metastatic Pancreatic Cancer

Interventions

DRUG

FG-3019

3mg/kg IV, 10mg/kg IV, 15mg/kg IV, 25mg/kg, 35mg/kg IV, 45mg/kg IV - Biweekly, 35/17.5mg/kg, 45/22.5 mg/kg - Weekly

Sponsors & Collaborators

  • FibroGen

    lead INDUSTRY

Principal Investigators

  • Albert C Koong, MD, PhD · Stanford University

  • J. Marc Pipas, MD · Dartmouth-Hitchcock Medical Center

  • Vincent J Picozzi, MD, PhD · Virginia Mason Hospital/Medical Center

  • Peter J O'Dwyer, MD · University of Pennsylvania

  • Smitha Krishnamurthi, MD · University Hospitals of Cleveland, Case Comprehensive Cancer Center

  • Charles Lopez, MD · Oregon Health and Science University

  • Nathan Bahary, MD · University of Pittsburgh

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2014-05-31
Completion
2014-06-30

Countries

  • United States

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 NCT01181245 on ClinicalTrials.gov