Locally Advanced or Metastatic Pancreatic CancerPhase 1NCT01181245
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
A Phase 1 study testing FG-3019 in people with Locally Advanced or Metastatic Pancreatic Cancer, run by Kyntra Bio at 7 sites in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Pancreatic Cancer
- What is being tested?
- FG-3019
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2008to Jun 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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%
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- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University Hospitals of Cleveland, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania
Oregon Health Sciences University (OHSU)
Portland, Oregon
Virginia Mason Medical Center
Seattle, Washington, 98101
Stanford University School of Medicine
Stanford, California, 94305-5152
About this study
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
- Being tested
- FG-3019
- Keywords
- Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FG-3019Drug
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
| Study group | Role | What they receive |
|---|---|---|
| FG-3019 | Experimental | All subjects are treated with FG-3019 Receives: Drug: FG-3019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinib
Measured: Through the end of the study
Secondary outcomes (4)
FG-3019 PK parameters
Measured: Through the end of the study
Time to Progression (TTP)
Measured: Through the end of the study
6-month, 12-month and overall median survival rates
Measured: Through the end of the study
Maximal tumor response as determined by RECIST criteria
Measured: Through the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startDec 2008
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyntra Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Albert C Koong, MD, PhD, Principal investigator, Stanford UniversityJ. Marc Pipas, MD, Principal investigator, Dartmouth-Hitchcock Medical CenterVincent J Picozzi, MD, PhD, Principal investigator, Virginia Mason Hospital/Medical CenterPeter J O'Dwyer, MD, Principal investigator, University of PennsylvaniaSmitha Krishnamurthi, MD, Principal investigator, University Hospitals of Cleveland, Case Comprehensive Cancer CenterCharles Lopez, MD, Principal investigator, Oregon Health and Science UniversityNathan Bahary, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181245
- Sponsor's protocol ID
- FGCL-MC3019-028
- Status last verified
- Aug 2014
- First submitted
- 4 May 2009
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01181245
- Acronym / sponsor ID
- FGCL-MC3019-028
- Keywords
- Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kyntra BioIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FG-3019 | Experimental | Drug: FG-3019All subjects are treated with FG-3019 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FG-30193mg/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 | Drug | FG-3019 |
Primary outcome
To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinib
Time frame: Through the end of the study
4 secondary outcomes
FG-3019 PK parameters
Time frame: Through the end of the study
Time to Progression (TTP)
Time frame: Through the end of the study
6-month, 12-month and overall median survival rates
Time frame: Through the end of the study
Maximal tumor response as determined by RECIST criteria
Time frame: Through the end of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert C Koong, MD, PhD principal investigator
Stanford University
J. Marc Pipas, MD principal investigator
Dartmouth-Hitchcock Medical Center
Vincent J Picozzi, MD, PhD principal investigator
Virginia Mason Hospital/Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FG-3019 in people with Locally Advanced or Metastatic Pancreatic Cancer, run by Kyntra Bio at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of FG-3019 in combination with gemcitabine and erlotinib (time frame: Through the end of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2014.