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
Primary Purpose
Locally Advanced or Metastatic Pancreatic Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FG-3019
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced or Metastatic Pancreatic Cancer focused on measuring Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria
- Written informed consent
- Males and females aged ≥18 years old
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Locally advanced (Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas
- 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)
- 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.
- ECOG performance status score of 0-1
- Life expectancy >12 weeks
- Ability to adhere to the study visit schedule and understand and comply with all protocol requirements and instructions from study staff
Exclusion Criteria
- Absolute neutrophil count (ANC) <500 cells/mm3
- Hemoglobin <10.0 g/dL
- Platelet count <100,000 cells/mm3
- Bilirubin >2.0 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2.5 x ULN, or >3.5 x ULN if liver metastases are present
- If the subject is diabetic, HbA1c >10%
- Current pregnancy or breast feeding due to recent pregnancy
- History of another malignancy in the past 2 years with the exception of basal cell or squamous cell carcinoma of the skin
- Previous chemotherapy with gemcitabine
- Previous systemic antineoplastic agent (other than adjuvant 5-fluorouracil as radio-sensitizer)
- Adjuvant 5-fluorouracil within 28 days prior to Day 1
- Major surgery within 28 days prior to Day 1 (stent placement is allowed)
- Radiation therapy within 28 days prior to Day 1
- Clinical evidence or any history of brain metastasis
- Uncontrolled hypertension (systolic blood pressure [SBP] >180 mmHg or diastolic blood pressure [DBP] >105 mmHg)
- New York Heart Association Class III or IV congestive heart failure
- History of allergic or anaphylactic reaction to human, humanized, or chimeric monoclonal antibodies
- Current clinical or laboratory evidence of active infection requiring antibiotic or antiviral therapy
- Active major gastrointestinal bleeding
- Full-dose heparin therapy within 28 days prior to Day 1
- Participation in studies of investigational products within 42 days prior to Day 1
- 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)
- Current abuse of alcohol or drugs
Sites / Locations
- Stanford University School of Medicine
- Dartmouth Hitchcock Medical Center
- University Hospitals of Cleveland, Case Comprehensive Cancer Center
- Oregon Health Sciences University (OHSU)
- University of Pennsylvania
- University of Pittsburgh
- Virginia Mason Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FG-3019
Arm Description
All subjects are treated with FG-3019
Outcomes
Primary Outcome Measures
To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinib
Secondary Outcome Measures
FG-3019 PK parameters
Time to Progression (TTP)
6-month, 12-month and overall median survival rates
Maximal tumor response as determined by RECIST criteria
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01181245
Brief 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
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 Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FibroGen
4. Oversight
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced or Metastatic Pancreatic Cancer
Keywords
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FG-3019
Arm Type
Experimental
Arm Description
All subjects are treated with FG-3019
Intervention Type
Drug
Intervention Name(s)
FG-3019
Intervention Description
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 Measure Information:
Title
To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinib
Time Frame
Through the end of the study
Secondary Outcome Measure Information:
Title
FG-3019 PK parameters
Time Frame
Through the end of the study
Title
Time to Progression (TTP)
Time Frame
Through the end of the study
Title
6-month, 12-month and overall median survival rates
Time Frame
Through the end of the study
Title
Maximal tumor response as determined by RECIST criteria
Time Frame
Through the end of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Written informed consent
Males and females aged ≥18 years old
Histologically or cytologically confirmed adenocarcinoma of the pancreas
Locally advanced (Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas
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)
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.
ECOG performance status score of 0-1
Life expectancy >12 weeks
Ability to adhere to the study visit schedule and understand and comply with all protocol requirements and instructions from study staff
Exclusion Criteria
Absolute neutrophil count (ANC) <500 cells/mm3
Hemoglobin <10.0 g/dL
Platelet count <100,000 cells/mm3
Bilirubin >2.0 x upper limit of normal (ULN)
Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2.5 x ULN, or >3.5 x ULN if liver metastases are present
If the subject is diabetic, HbA1c >10%
Current pregnancy or breast feeding due to recent pregnancy
History of another malignancy in the past 2 years with the exception of basal cell or squamous cell carcinoma of the skin
Previous chemotherapy with gemcitabine
Previous systemic antineoplastic agent (other than adjuvant 5-fluorouracil as radio-sensitizer)
Adjuvant 5-fluorouracil within 28 days prior to Day 1
Major surgery within 28 days prior to Day 1 (stent placement is allowed)
Radiation therapy within 28 days prior to Day 1
Clinical evidence or any history of brain metastasis
Uncontrolled hypertension (systolic blood pressure [SBP] >180 mmHg or diastolic blood pressure [DBP] >105 mmHg)
New York Heart Association Class III or IV congestive heart failure
History of allergic or anaphylactic reaction to human, humanized, or chimeric monoclonal antibodies
Current clinical or laboratory evidence of active infection requiring antibiotic or antiviral therapy
Active major gastrointestinal bleeding
Full-dose heparin therapy within 28 days prior to Day 1
Participation in studies of investigational products within 42 days prior to Day 1
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)
Current abuse of alcohol or drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert C Koong, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J. Marc Pipas, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vincent J Picozzi, MD, PhD
Organizational Affiliation
Virginia Mason Hospital/Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter J O'Dwyer, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Smitha Krishnamurthi, MD
Organizational Affiliation
University Hospitals of Cleveland, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles Lopez, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nathan Bahary, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5152
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
University Hospitals of Cleveland, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Oregon Health Sciences University (OHSU)
City
Portland
State/Province
Oregon
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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