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

NCT01181245 | Completed Phase 1 DMC

• 1 other identifier: FGCL-MC3019-028
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 7

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

Keywords

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinib

  Through the end of the study

Secondary Outcomes (4)

• 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

Study Arms (1)

FG-3019

EXPERIMENTAL

All subjects are treated with FG-3019

Drug: FG-3019

Interventions

FG-3019 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

FG-3019

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kyntra Bio: lead

Study Sites (7)

Stanford University School of Medicine

Stanford, California, 94305-5152, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

University Hospitals of Cleveland, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Oregon Health Sciences University (OHSU)

Portland, Oregon, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

pamrevlumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2009
• First Posted: August 13, 2010
• Study Start: December 1, 2008
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 6, 2014

Record last verified: 2014-08

Locations

US (7)