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

NCT ID: NCT01181245

Last Updated: 2014-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2014-06-30

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

Conditions

Locally Advanced or Metastatic Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FG-3019

All subjects are treated with FG-3019

Group Type: EXPERIMENTAL

FG-3019

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FibroGen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Albert C Koong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

J. Marc Pipas, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Vincent J Picozzi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Mason Hospital/Medical Center

Peter J O'Dwyer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Smitha Krishnamurthi, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals of Cleveland, Case Comprehensive Cancer Center

Charles Lopez, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Nathan Bahary, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Stanford University School of Medicine

Stanford, California, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

University Hospitals of Cleveland, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Oregon Health Sciences University (OHSU)

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

FGCL-MC3019-028

Identifier Type: -

Identifier Source: org_study_id