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

Locally Advanced or Metastatic Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181245
• Other study ID #: FGCL-MC3019-028
• Status: Completed
• Phase: Phase 1
• First received: May 4, 2009
• Last updated: August 4, 2014
• Start date: December 2008
• Est. completion date: June 2014

Study information

• Verified date: August 2014
• Source: FibroGen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Locally Advanced or Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University Hospitals of Cleveland, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health Sciences University (OHSU)	Portland	Oregon
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
FibroGen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinib		Through the end of the study	Yes
Secondary	FG-3019 PK parameters		Through the end of the study	No
Secondary	Time to Progression (TTP)		Through the end of the study	No
Secondary	6-month, 12-month and overall median survival rates		Through the end of the study	No
Secondary	Maximal tumor response as determined by RECIST criteria		Through the end of the study	No