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

• ClinicalTrials.gov Identifier: NCT01181245
• Recruitment Status: Completed
• First Posted: August 13, 2010
• Last Update Posted: August 6, 2014
• Sponsor: FibroGen
• Information provided by (Responsible Party): FibroGen

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

Study Design

• 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

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 [ Time Frame: Through the end of the study ]

Secondary Outcome Measures :

1. FG-3019 PK parameters [ Time Frame: Through the end of the study ]
2. Time to Progression (TTP) [ Time Frame: Through the end of the study ]
3. 6-month, 12-month and overall median survival rates [ Time Frame: Through the end of the study ]
4. Maximal tumor response as determined by RECIST criteria [ Time Frame: Through the end of the study ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: FibroGen
• ClinicalTrials.gov Identifier: NCT01181245
• Other Study ID Numbers: FGCL-MC3019-028
• First Posted: August 13, 2010
• Last Update Posted: August 6, 2014
• Last Verified: August 2014

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