Pancreatic CancerPhase 2NCT01608711
A Study of AGS-1C4D4 in Pancreatic Cancer Subjects Previously Treated in Protocol 2008002
A Phase 2 study testing AGS-1C4D4 and gemcitabine in people with Pancreatic Cancer and Carcinoma, Pancreatic Ductal, run by Agensys, Inc. at 2 sites in 2 countries.
Trial summary
The purpose of this study is to continue the safety and immunogenicity of AGS-1C4D4 administered in combination with gemcitabine in subjects previously treated in protocol 2008002. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Carcinoma, Pancreatic Ductal, Pancreatic Disease
- What is being tested?
- AGS-1C4D4 and gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Aug 2012to 16 Nov 2015
- Phase
- Phase 2
- 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
- Subject has stable disease or better per Response Evaluation Criteria in Solid Tumors (RECIST) criteria v.1.1. in Protocol 2008002
Who cannot join
- More than 6 weeks (2 doses) has lapsed from the time of the last infusion in AGS-1C4D4 Protocol 2008002
- Use of the following prohibited medications / therapies:
- Monoclonal antibody therapy, other than AGS-1C4D4
- Chemotherapy, other than gemcitabine
- Investigational therapy other than AGS-1C4D4
- Erlotinib (Tarceva)
- Any clinical condition which would not allow safe conduct of this study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: An Open-Label Phase 2 Study of AGS-1C4D4 in Pancreatic Cancer Subjects Previously Treated in Protocol 2008002
The purpose of this study is to continue the safety and immunogenicity of AGS-1C4D4 administered in combination with gemcitabine in subjects previously treated in protocol 2008002.
Read the detailed description
Subjects will receive a maintenance dose of AGS-1C4D4 every 3 weeks (Q3W) in addition to the gemcitabine administration. If subjects have grade 4 adverse events considered to be related to AGS-1C4D4 at anytime during the study, AGS-1C4D4 treatment will be discontinued for that subject.
Subjects will continue to have their tumor status assessed by computerized tomography (CT) and magnetic resonance (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) guidelines every eight weeks (Q8W). Subjects without evidence of disease progression will continue to receive AGS-1C4D4 and gemcitabine until intolerability, disease progression or consent withdrawal.
Subjects who discontinue AGS-1C4D4 for any reason will undergo an end of study visit 4 weeks after their last AGS-1C4D4 infusion.
- Being tested
- AGS-1C4D4, gemcitabine
- Keywords
- Gemcitabine, ASP6182, AGS-1C4D4, Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms, Carcinoma, Pancreatic Ductal, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGS-1C4D4Biological
Also called ASP6182
Intravenous Infusion
gemcitabineBiological
Intravenous Infusion
| Study group | Role | What they receive |
|---|---|---|
| AGS-1C4D4 plus gemcitabine | Experimental | Subjects will receive a maintenance dose of AGS-1C4D4 every 3 weeks (Q3W) in addition to the gemcitabine administration. Receives: Biological: AGS-1C4D4; Biological: gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Grade 3 and 4 adverse events, treatment-related adverse events, serious adverse events and adverse events requiring discontinuation of AGS-1C4D4
Measured: 31 months
Incidence of anti-AGS-1C4D4 antibody formation
Measured: Every 8 weeks (up to 31 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study start7 Aug 2012
- Primary completion16 Nov 2015
- Study completion16 Nov 2015
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agensys, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Agensys, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608711
- Sponsor's protocol ID
- AGS-1C4D4-12-3
- Status last verified
- May 2017
- First submitted
- 29 May 2012
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 2 Study of AGS-1C4D4 in Pancreatic Cancer Subjects Previously Treated in Protocol 2008002
- ClinicalTrials.gov ID
- NCT01608711
- Acronym / sponsor ID
- AGS-1C4D4-12-3
- Keywords
- Gemcitabine, ASP6182, AGS-1C4D4, Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Agensys, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2012 (actual)
- Primary completion
- 16 Nov 2015 (actual)
- Study completion
- 16 Nov 2015 (actual)
- First posted
- 31 May 2012 (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.
The purpose of this study is to continue the safety and immunogenicity of AGS-1C4D4 administered in combination with gemcitabine in subjects previously treated in protocol 2008002.
Detailed description
Subjects will receive a maintenance dose of AGS-1C4D4 every 3 weeks (Q3W) in addition to the gemcitabine administration. If subjects have grade 4 adverse events considered to be related to AGS-1C4D4 at anytime during the study, AGS-1C4D4 treatment will be discontinued for that subject.
Subjects will continue to have their tumor status assessed by computerized tomography (CT) and magnetic resonance (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) guidelines every eight weeks (Q8W). Subjects without evidence of disease progression will continue to receive AGS-1C4D4 and gemcitabine until intolerability, disease progression or consent withdrawal.
Subjects who discontinue AGS-1C4D4 for any reason will undergo an end of study visit 4 weeks after their last AGS-1C4D4 infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AGS-1C4D4 plus gemcitabine | Experimental | Biological: AGS-1C4D4, Biological: gemcitabineSubjects will receive a maintenance dose of AGS-1C4D4 every 3 weeks (Q3W) in addition to the gemcitabine administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject has stable disease or better per Response Evaluation Criteria in Solid Tumors (RECIST) criteria v.1.1. in Protocol 2008002
Key exclusion criteria (7 listed)
- More than 6 weeks (2 doses) has lapsed from the time of the last infusion in AGS-1C4D4 Protocol 2008002
- Use of the following prohibited medications / therapies:
- Any clinical condition which would not allow safe conduct of this study
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 |
|---|---|---|
| AGS-1C4D4Also: ASP6182Intravenous Infusion | Biological | AGS-1C4D4 plus gemcitabine |
| gemcitabineIntravenous Infusion | Biological | AGS-1C4D4 plus gemcitabine |
Primary outcome
Incidence of adverse events
Time frame: 31 months
Grade 3 and 4 adverse events, treatment-related adverse events, serious adverse events and adverse events requiring discontinuation of AGS-1C4D4
Incidence of anti-AGS-1C4D4 antibody formation
Time frame: Every 8 weeks (up to 31 months)
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 16 May 2017.
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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.
Medical Monitor study director
Agensys, Inc.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AGS-1C4D4 and gemcitabine in people with Pancreatic Cancer and Carcinoma, Pancreatic Ductal, run by Agensys, Inc. at 2 sites in 2 countries.
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 1 inclusion and 7 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 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Incidence of adverse events (time frame: 31 months). The study lists 2 primary outcomes in all. 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 16 May 2017.