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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

Sponsor
FibroGen (Industry)
Overall Status
Completed
CT.gov ID
NCT01181245
Collaborator
(none)
50
Enrollment
7
Locations
1
Arm
66
Duration (Months)
7.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Dec 1, 2008
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/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

Outcome Measures

Primary Outcome Measures

  1. To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinib [Through the end of the study]

Secondary Outcome Measures

  1. FG-3019 PK parameters [Through the end of the study]

  2. Time to Progression (TTP) [Through the end of the study]

  3. 6-month, 12-month and overall median survival rates [Through the end of the study]

  4. Maximal tumor response as determined by RECIST criteria [Through the end of the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

  1. If the subject is diabetic, HbA1c >10%

  2. Current pregnancy or breast feeding due to recent pregnancy

  3. History of another malignancy in the past 2 years with the exception of basal cell or squamous cell carcinoma of the skin

  4. Previous chemotherapy with gemcitabine

  5. Previous systemic antineoplastic agent (other than adjuvant 5-fluorouracil as radio-sensitizer)

  6. Adjuvant 5-fluorouracil within 28 days prior to Day 1

  7. Major surgery within 28 days prior to Day 1 (stent placement is allowed)

  8. Radiation therapy within 28 days prior to Day 1

  9. Clinical evidence or any history of brain metastasis

  10. Uncontrolled hypertension (systolic blood pressure [SBP] >180 mmHg or diastolic blood pressure [DBP] >105 mmHg)

  11. New York Heart Association Class III or IV congestive heart failure

  12. History of allergic or anaphylactic reaction to human, humanized, or chimeric monoclonal antibodies

  13. Current clinical or laboratory evidence of active infection requiring antibiotic or antiviral therapy

  14. Active major gastrointestinal bleeding

  15. Full-dose heparin therapy within 28 days prior to Day 1

  16. Participation in studies of investigational products within 42 days prior to Day 1

  17. 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)

  18. Current abuse of alcohol or drugs

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University School of Medicine Stanford California United States 94305-5152
2 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
3 University Hospitals of Cleveland, Case Comprehensive Cancer Center Cleveland Ohio United States 44106
4 Oregon Health Sciences University (OHSU) Portland Oregon United States
5 University of Pennsylvania Philadelphia Pennsylvania United States 19104
6 University of Pittsburgh Pittsburgh Pennsylvania United States
7 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
FibroGen
ClinicalTrials.gov Identifier:
NCT01181245
Other Study ID Numbers:
  • FGCL-MC3019-028
First Posted:
Aug 13, 2010
Last Update Posted:
Aug 6, 2014
Last Verified:
Aug 1, 2014
Keywords provided by FibroGen
Pancreatic Cancer
Additional relevant MeSH terms:
Pancreatic Neoplasms

Study Results

No Results Posted as of Aug 6, 2014