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

August 4, 2014 updated by: FibroGen

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305-5152
        • Stanford University School of Medicine
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland, Case Comprehensive Cancer Center
    • Oregon
      • Portland, Oregon, United States
        • Oregon Health Sciences University (OHSU)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • UNIVERSITY of PENNSYLVANIA
      • Pittsburgh, Pennsylvania, United States
        • University of Pittsburgh
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: FG-3019
All subjects are treated with FG-3019
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinib
Time Frame: Through the end of the study
Through the end of the study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
FG-3019 PK parameters
Time Frame: Through the end of the study
Through the end of the study
Time to Progression (TTP)
Time Frame: Through the end of the study
Through the end of the study
6-month, 12-month and overall median survival rates
Time Frame: Through the end of the study
Through the end of the study
Maximal tumor response as determined by RECIST criteria
Time Frame: Through the end of the study
Through the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
FibroGen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FGCL-MC3019-028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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