Pancreatic CancerNCT02851381
Compassionate Single Subject Use of FG-3019 (FibroGen) in Locally Advanced, Unresectable Pancreatic Cancer
A study testing FG-3019 in people with Pancreatic Cancer, run by Jonsson Comprehensive Cancer Center.
Trial summary
Single compassionate use subject is an 83 year old woman with a history of lymph node positive breast cancer and recently diagnosed pancreatic cancer in May. With an Eastern Cooperative Oncology Group (ECOG) of 2, it is felt that she cannot tolerate more aggressive chemotherapy. Read more about this study
- Who is it for?
- Ages 83 to 83 years, women only
- Conditions the study is for
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Aug 2017
- Phase
- Interventional
- 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 83 to 83 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Signed Consent form
- Have adequate liver function
- Have adequate bone marrow function
Who cannot join
- History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies
- Any medical or surgical condition that may place the subject at increased risk while on treatment
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with treatment requirements
- Current abuse of alcohol or drugs
About this study
Official title: Compassionate Single Subject Use of FG-3019 in Locally Advanced, Unresectable Pancreatic Cancer (Emergency Use of a Test Article)
Single compassionate use subject is an 83 year old woman with a history of lymph node positive breast cancer and recently diagnosed pancreatic cancer in May. With an Eastern Cooperative Oncology Group (ECOG) of 2, it is felt that she cannot tolerate more aggressive chemotherapy. The investigators propose to administer FG-3019 on a compassionate pleas basis in combination with gemzar. The patient is currently being treated and is tolerating gemzar.
Read the detailed description
The FG-3019 treatment will be administered over a 28-day cycle:
- Dose: 35 mg/kg
- Route: IV over one hour following completion of gemcitabine infusion
- Schedule:
- Days 1, 8, and 15
- Please note that Day 8 infusion will on be completed during the first treatment cycle
On Drug Evaluation
The patient will be seen prior to every FG-3019 treatment by the treating physician. The following procedures will be conducted at each visit:
- History and thorough symptom assessment
- Physical examination
- Laboratory assessments (these can be collected up to 3 days prior to treatment):
- Complete blood count (CBC) and differential
- Comprehensive Metabolic Panel (Chemistry): bicarbonate, blood, urea, nitrogen (BUN), calcium, creatinine, glucose, potassium, sodium
- Liver Function Tests: Alkaline phosphatase (ALP), Alanine transaminase (ALT), Aspartate transaminase (AST), total bilirubin
- Carbohydrate antigen (CA) 19-9
ECGs will be conducted during the screening and end of treatment visits. CT scans of the chest and abdomen will be done every 12 to 16 weeks.
All of these data will be recorded and stored with their source documents.
- Conditions
- Pancreatic Cancer
- Being tested
- FG-3019
- 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
The FG-3019 treatment will be administered over a 28-day cycle:
- Dose: 35 mg/kg
- Route: IV over one hour following completion of gemcitabine infusion
- Schedule:
- Days 1, 8, and 15
- Please note that Day 8 infusion will on be completed during the first treatment cycle
| Study group | Role | What they receive |
|---|---|---|
| FG-3019 | Other | Treatment of Pancreatic Cancer with FG-3019 Receives: Drug: FG-3019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
FG-3019 treatment regimen to increase OS (overall survival)
Measured: 7.7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2016 (estimated)
- Study completionAug 2017 (estimated)
Why it stopped: The patient passed before treatment could be started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Glaspy, M.D., Principal investigator, Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851381
- Sponsor's protocol ID
- 16-001170
- Status last verified
- Jul 2016
- First submitted
- 26 Jul 2016
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Single Subject Use of FG-3019 in Locally Advanced, Unresectable Pancreatic Cancer (Emergency Use of a Test Article)
- ClinicalTrials.gov ID
- NCT02851381
- Acronym / sponsor ID
- 16-001170
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The patient passed before treatment could be started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 1 Aug 2016 (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.
Single compassionate use subject is an 83 year old woman with a history of lymph node positive breast cancer and recently diagnosed pancreatic cancer in May. With an Eastern Cooperative Oncology Group (ECOG) of 2, it is felt that she cannot tolerate more aggressive chemotherapy. The investigators propose to administer FG-3019 on a compassionate pleas basis in combination with gemzar. The patient is currently being treated and is tolerating gemzar.
Detailed description
The FG-3019 treatment will be administered over a 28-day cycle:
- Dose: 35 mg/kg
- Route: IV over one hour following completion of gemcitabine infusion
- Schedule:
- Days 1, 8, and 15
- Please note that Day 8 infusion will on be completed during the first treatment cycle
On Drug Evaluation
The patient will be seen prior to every FG-3019 treatment by the treating physician. The following procedures will be conducted at each visit:
- History and thorough symptom assessment
- Physical examination
- Laboratory assessments (these can be collected up to 3 days prior to treatment):
- Complete blood count (CBC) and differential
- Comprehensive Metabolic Panel (Chemistry): bicarbonate, blood, urea, nitrogen (BUN), calcium, creatinine, glucose, potassium, sodium
- Liver Function Tests: Alkaline phosphatase (ALP), Alanine transaminase (ALT), Aspartate transaminase (AST), total bilirubin
- Carbohydrate antigen (CA) 19-9
ECGs will be conducted during the screening and end of treatment visits. CT scans of the chest and abdomen will be done every 12 to 16 weeks.
All of these data will be recorded and stored with their source documents.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FG-3019 | Other | Drug: FG-3019Treatment of Pancreatic Cancer with FG-3019 |
Who may qualify
- Ages
- 83 to 83 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Signed Consent form
- Have adequate liver function
- Have adequate bone marrow function
Key exclusion criteria (4 listed)
- History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies
- Any medical or surgical condition that may place the subject at increased risk while on treatment
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with treatment requirements
- Current abuse of alcohol or drugs
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-3019The FG-3019 treatment will be administered over a 28-day cycle: * Dose: 35 mg/kg * Route: IV over one hour following completion of gemcitabine infusion * Schedule: * Days 1, 8, and 15 * Please note that Day 8 infusion will on be completed during the first treatment cycle | Drug | FG-3019 |
Primary outcome
FG-3019 treatment regimen to increase OS (overall survival)
Time frame: 7.7 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- Individual participant dataSharing planned: No
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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.
John Glaspy, M.D. principal investigator
Professor of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing FG-3019 in people with Pancreatic Cancer, run by Jonsson Comprehensive Cancer Center.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
FG-3019 treatment regimen to increase OS (overall survival) (time frame: 7.7 months). 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 7 Oct 2016.