Previously Treated Metastatic Pancreatic CancerPhase 2NCT01196247
A Study of Therapy Selected by Molecular/Metabolic Profiling in Patients With Previously Treated Metastatic Pancreatic Cancer
A Phase 2 study testing Drug will be recommended based on IHC/Fish, CGH and Pan-XenoBank in people with Previously Treated Metastatic Pancreatic Cancer, run by Translational Drug Development at 1 site in United States.
Trial summary
The purpose of the study is selecting second line therapy for patients with pancreatic cancer using molecular profiling will improve 1 year survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Previously Treated Metastatic Pancreatic Cancer
- What is being tested?
- Drug will be recommended based on IHC/Fish, CGH and Pan-XenoBank
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Feb 2012
- 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
- metastatic adenocarcinoma of the pancreas
- male or non-pregnant female
- 18 years of age or greater
- one prior therapy for the treatment of metastatic disease
- must start continuation therapy within 9 months of starting first line treatment
- have adequate organ and bone marrow function
- must have a Karnofsky performance status greater than or equal to 70
- one or more metastatic tumors measurable by CT scan and accessible for biopsy
Who cannot join
- operable or locally advanced pancreatic cancer
- metastatic tumor that is not amendable to biopsy
- known brain mets unless previously treated and well controlled
- active, uncontrolled bacterial, viral or fungal infections
- known infection with HIV, hepatitis B or hepatitis C
- pregnant or breast-feeding patients
Trial locations and contacts
1 site in 1 country.
United States1 site
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, 85258
About this study
Official title: Stand Up to Cancer Consortium: Phase II Study of Therapy Selected by Molecular/Metabolic Profiling in Patients With Previously Treated With Metastatic Pancreatic Cancer
The purpose of the study is selecting second line therapy for patients with pancreatic cancer using molecular profiling will improve 1 year survival.
Read the detailed description
Following first-line therapy with a gemcitabine based regimen, a significant number of patients will maintain an adequate performance status and be able to tolerate a second-line therapy. A recent phase III trial randomized patients to either 5-flurouracil (5FU), folinic acid or to the addition of weekly oxaliplatin to the same regimen of 5FU/folinic acid. The interim results showed a statistically significant survival advantage for the oxaliplatin containing arm (26 versus 13 weeks, P= 0.014). However the outcome of patients who have progressed on a first-line gemcitabine regimen is still poor with median survival of about 2-6 months.
Almost all patients with advanced APC, treated with gemcitabine alone or a gemcitabine based combination therapy will exhibit resistance to therapy. In patients treated with gemcitabine alone, the time to progression (TTP) is about 3-4 months. Thus most patients will exhibit progression and /or toxicity and will require second line therapy at 4-6 months into first line therapy. The best one year survival reported in a phase II trial is only 24%. However there is no standard second line therapy for APC, a rapid progression of tumor is seen in this setting, and new strategies based on rational target identification are needed. In this study we propose to select therapy based on the molecular profiling of each patients tumor.
- Being tested
- Drug will be recommended based on IHC/Fish, CGH and Pan-XenoBank
- Keywords
- pancreatic cancer, molecular profiling, SU2C, Second line therapy, Stage 4
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug will be recommended based on IHC/Fish, CGH and Pan-XenoBankDrug
Also called FDA approved drugs as indicated by molecular profiling
FDA approved drugs as indicated by molecular profiling
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the percent of patients who are alive at one year
Goal is to improve the one year survival (from start of first-line therapy for metastatic disease) to 60%
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionNov 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Previously Treated 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Drug Development
- Sponsor type
- University, hospital or other
- Collaborators
- Scottsdale Healthcare, Stand Up To Cancer, American Association for Cancer Research
- Investigators
- Ramesh Ramanathan, MD, Principal investigator, TGen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196247
- Sponsor's protocol ID
- SU2C-001
- Status last verified
- Jul 2012
- First submitted
- 3 Sep 2010
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stand Up to Cancer Consortium: Phase II Study of Therapy Selected by Molecular/Metabolic Profiling in Patients With Previously Treated With Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01196247
- Acronym / sponsor ID
- SU2C-001
- Keywords
- pancreatic cancer, molecular profiling, SU2C, Second line therapy, Stage 4
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Translational Drug DevelopmentUniversity, hospital or other
- Collaborators
- Scottsdale Healthcare, Stand Up To Cancer, American Association for Cancer Research
- Study start
- Sep 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 8 Sep 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.
The purpose of the study is selecting second line therapy for patients with pancreatic cancer using molecular profiling will improve 1 year survival.
Detailed description
Following first-line therapy with a gemcitabine based regimen, a significant number of patients will maintain an adequate performance status and be able to tolerate a second-line therapy. A recent phase III trial randomized patients to either 5-flurouracil (5FU), folinic acid or to the addition of weekly oxaliplatin to the same regimen of 5FU/folinic acid. The interim results showed a statistically significant survival advantage for the oxaliplatin containing arm (26 versus 13 weeks, P= 0.014). However the outcome of patients who have progressed on a first-line gemcitabine regimen is still poor with median survival of about 2-6 months.
Almost all patients with advanced APC, treated with gemcitabine alone or a gemcitabine based combination therapy will exhibit resistance to therapy. In patients treated with gemcitabine alone, the time to progression (TTP) is about 3-4 months. Thus most patients will exhibit progression and /or toxicity and will require second line therapy at 4-6 months into first line therapy. The best one year survival reported in a phase II trial is only 24%. However there is no standard second line therapy for APC, a rapid progression of tumor is seen in this setting, and new strategies based on rational target identification are needed. In this study we propose to select therapy based on the molecular profiling of each patients tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- metastatic adenocarcinoma of the pancreas
- male or non-pregnant female
- 18 years of age or greater
- one prior therapy for the treatment of metastatic disease
- must start continuation therapy within 9 months of starting first line treatment
Key exclusion criteria (6 listed)
- operable or locally advanced pancreatic cancer
- metastatic tumor that is not amendable to biopsy
- known brain mets unless previously treated and well controlled
- active, uncontrolled bacterial, viral or fungal infections
- known infection with HIV, hepatitis B or hepatitis C
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 |
|---|---|---|
| Drug will be recommended based on IHC/Fish, CGH and Pan-XenoBankAlso: FDA approved drugs as indicated by molecular profilingFDA approved drugs as indicated by molecular profiling | Drug | – |
Primary outcome
Determine the percent of patients who are alive at one year
Time frame: One year
Goal is to improve the one year survival (from start of first-line therapy for metastatic disease) to 60%
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 17 Jul 2012.
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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.
Ramesh Ramanathan, MD principal investigator
TGen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Drug will be recommended based on IHC/Fish, CGH and Pan-XenoBank in people with Previously Treated Metastatic Pancreatic Cancer, run by Translational Drug Development at 1 site 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 8 inclusion and 6 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 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Determine the percent of patients who are alive at one year (time frame: One year). 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 17 Jul 2012.