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Clinical Trial Record

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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

2008-12

2014-05

2014-06

50

Study Overview

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

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

N/A

  • Locally Advanced or Metastatic Pancreatic Cancer
  • DRUG: FG-3019
  • FGCL-MC3019-028

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2009-05-04  

N/A  

2014-08-04  

2010-08-12  

N/A  

2014-08-06  

2010-08-13  

N/A  

2014-08  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: FG-3019

All subjects are treated with FG-3019

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
Primary Outcome MeasuresMeasure DescriptionTime Frame
To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinibThrough the end of the study
Secondary Outcome MeasuresMeasure DescriptionTime Frame
FG-3019 PK parametersThrough the end of the study
Time to Progression (TTP)Through the end of the study
6-month, 12-month and overall median survival ratesThrough the end of the study
Maximal tumor response as determined by RECIST criteriaThrough the end of the study

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria
    1. Written informed consent 2. Males and females aged ≥18 years old 3. Histologically or cytologically confirmed adenocarcinoma of the pancreas 4. Locally advanced (Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas 5. Spiral CT scan demonstrating at least one pancreatic adenocarcinoma measurable lesion according to RECIST criteria and PET scan showing metabolically active lesion (for the last six subjects in the 15 mg/kg and the subjects in the 25 mg/kg FG-3019 dose cohorts only) 6. Women of childbearing potential and men must use effective contraception during and for at least 90 days following study participation. Women of childbearing potential must have a negative Screening serum pregnancy test. 7. ECOG performance status score of 0-1 8. Life expectancy >12 weeks 9. Ability to adhere to the study visit schedule and understand and comply with all protocol requirements and instructions from study staff
    Exclusion Criteria
    1. Absolute neutrophil count (ANC) <500 cells/mm3 2. Hemoglobin <10.0 g/dL 3. Platelet count <100,000 cells/mm3 4. Bilirubin >2.0 x upper limit of normal (ULN) 5. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2.5 x ULN, or >3.5 x ULN if liver metastases are present 6. If the subject is diabetic, HbA1c >10% 7. Current pregnancy or breast feeding due to recent pregnancy 8. History of another malignancy in the past 2 years with the exception of basal cell or squamous cell carcinoma of the skin 9. Previous chemotherapy with gemcitabine 10. Previous systemic antineoplastic agent (other than adjuvant 5-fluorouracil as radio-sensitizer) 11. Adjuvant 5-fluorouracil within 28 days prior to Day 1 12. Major surgery within 28 days prior to Day 1 (stent placement is allowed) 13. Radiation therapy within 28 days prior to Day 1 14. Clinical evidence or any history of brain metastasis 15. Uncontrolled hypertension (systolic blood pressure [SBP] >180 mmHg or diastolic blood pressure [DBP] >105 mmHg) 16. New York Heart Association Class III or IV congestive heart failure 17. History of allergic or anaphylactic reaction to human, humanized, or chimeric monoclonal antibodies 18. Current clinical or laboratory evidence of active infection requiring antibiotic or antiviral therapy 19. Active major gastrointestinal bleeding 20. Full-dose heparin therapy within 28 days prior to Day 1 21. Participation in studies of investigational products within 42 days prior to Day 1 22. Clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study or a likelihood that the subject will be unable to comply with protocol requirements and complete the trial (e.g., emphysema requiring supplemental oxygen, poorly controlled arrhythmia, psychiatric illness, Alzheimer's disease) 23. Current abuse of alcohol or drugs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Albert C Koong, MD, PhD, Stanford University

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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