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 Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Locally Advanced or Metastatic Pancreatic Cancer

Intervention / Treatment
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* Drug: FG-3019


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FG-3019<br>All subjects are treated with FG-3019 | Drug: FG-3019<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinib |  | Through the end of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FG-3019 PK parameters |  | Through the end of the study | 
| Time to Progression (TTP) |  | Through the end of the study | 
| 6-month, 12-month and overall median survival rates |  | Through the end of the study | 
| Maximal tumor response as determined by RECIST criteria |  | Through the end of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic Cancer