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
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01181245 |
Recruitment Status :
Completed
First Posted : August 13, 2010
Last Update Posted : August 6, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
---|---|---|
Locally Advanced or Metastatic Pancreatic Cancer | Drug: FG-3019 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 : | December 2008 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | June 2014 |

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 |
- To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinib [ Time Frame: Through the end of the study ]
- FG-3019 PK parameters [ Time Frame: Through the end of the study ]
- Time to Progression (TTP) [ Time Frame: Through the end of the study ]
- 6-month, 12-month and overall median survival rates [ Time Frame: Through the end of the study ]
- Maximal tumor response as determined by RECIST criteria [ Time Frame: Through the end of the study ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181245
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 |
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 |
Responsible Party: | FibroGen |
ClinicalTrials.gov Identifier: | NCT01181245 |
Other Study ID Numbers: |
FGCL-MC3019-028 |
First Posted: | August 13, 2010 Key Record Dates |
Last Update Posted: | August 6, 2014 |
Last Verified: | August 2014 |
Pancreatic Cancer |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |