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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
FibroGen
ClinicalTrials.gov Identifier:
NCT01181245
First received: May 4, 2009
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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

Condition Intervention Phase
Locally Advanced or Metastatic Pancreatic Cancer
Drug: FG-3019
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by FibroGen:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinib [ Time Frame: Through the end of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • FG-3019 PK parameters [ Time Frame: Through the end of the study ] [ Designated as safety issue: No ]
  • Time to Progression (TTP) [ Time Frame: Through the end of the study ] [ Designated as safety issue: No ]
  • 6-month, 12-month and overall median survival rates [ Time Frame: Through the end of the study ] [ Designated as safety issue: No ]
  • Maximal tumor response as determined by RECIST criteria [ Time Frame: Through the end of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: FG-3019
    3mg/kg IV, 10mg/kg IV, 15mg/kg IV, 25mg/kg, 35mg/kg IV, 45mg/kg IV
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01181245

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305-5152
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, Ohio
University Hospitals of Cleveland, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
United States, Oregon
Oregon Health Sciences University (OHSU)
Portland, Oregon, United States
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
FibroGen
Investigators
Principal Investigator: Albert C Koong, MD, PhD Stanford University
Principal Investigator: J. Marc Pipas, MD Dartmouth-Hitchcock Medical Center
Principal Investigator: Vincent J Picozzi, MD, PhD Virginia Mason Hospital/Medical Center
Principal Investigator: Peter J O'Dwyer, MD University of Pennsylvania
Principal Investigator: Smitha Krishnamurthi, MD University Hospitals of Cleveland, Case Comprehensive Cancer Center
Principal Investigator: Charles Lopez, MD Oregon Health and Science University
Principal Investigator: Nathan Bahary, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT01181245     History of Changes
Other Study ID Numbers: FGCL-MC3019-028
Study First Received: May 4, 2009
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by FibroGen:
Pancreatic Cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Erlotinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014