Clinical trial NCT01181245: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Locally Advanced or Metastatic Pancreatic Cancer
Keywords: Pancreatic Cancer
Lead sponsor: FibroGen
Sponsor class: INDUSTRY
First posted: 2010-08-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinib
timeFrame: Through the end of the study
Secondary outcomes:
measure: FG-3019 PK parameters
timeFrame: Through the end of the study
measure: Time to Progression (TTP)
timeFrame: Through the end of the study
measure: 6-month, 12-month and overall median survival rates
timeFrame: Through the end of the study
measure: Maximal tumor response as determined by RECIST criteria
timeFrame: Through the end of the study
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Cleveland
country: United States
facility: University Hospitals of Cleveland, Case Comprehensive Cancer Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University (OHSU)
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Stanford University
name: Albert C Koong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth-Hitchcock Medical Center
name: J. Marc Pipas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Mason Hospital/Medical Center
name: Vincent J Picozzi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Peter J O'Dwyer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals of Cleveland, Case Comprehensive Cancer Center
name: Smitha Krishnamurthi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Charles Lopez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Nathan Bahary, MD
role: PRINCIPAL_INVESTIGATOR
References: