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NCT01313416 · ClinicalTrials.gov registry record · Phase 2
Gemcitabine and CT-011 for Resected Pancreatic Cancer
A Phase 2 study, sponsored by Augusta University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT01313416: Clinical Trial Phase 2 study, sponsored by Augusta University.
NCT01313416 is a Phase 2 study that was terminated before completion, run by Augusta University. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01313416, a Phase 2 study, was terminated before completion, sponsored by Augusta University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
Background: * In 2009, 49,096 patients were diagnosed with pancreatic cancer. Pancreatic cancer carries a poor prognosis with an overall 5-year relative survival rate of 5.6%. * Many doctors believe that individuals who have had surgery to remove pancreatic cancer should receive additional treatment, known as adjuvant therapy or adjuvant treatment, to prevent the cancer from returning. One chemotherapy drug that has been found to be effective in some patients with pancreatic cancer is called gemcitabine; it has been shown to improve patient survival by 6 months. Researchers are searching for new drugs or drug combinations to improve on these results. * One of the leading causes for immune suppression in cancer patients was suggested to be associated with the elevated expression of programmed cell death ligand 1 (PD-L1) human B7 homolog 1 (B7-H1) at tumor-involved sites, either by the tumor itself or by surrounding cells like regulatory immune cells, resulting in the local suppression and apoptosis of tumor infiltrating effector lymphocytes. * Some chemotherapy drugs kill cancer cells directly, but appear to prevent the immune system from helping in that fight. The experimental drug CT-011 is designed to help the immune system remain active to fight cancer cells. CT-011 has been tested in laboratories and studied for use with a number of other cancers, but it has not been given in combination with gemcitabine as a treatment for pancreatic cancer. Objective: \- To test the safety and effectiveness of chemotherapy drugs gemcitabine and CT-011 as a follow-up treatment for pancreatic cancer that has been surgically removed. Eligibility: \- Individuals at least 18 years of age who have had surgery to remove pancreatic cancer and have not had other types of follow-up treatments. Design: * Participants will receive gemcitabine and CT-011 in 28-day cycles of treatment, and will be monitored throughout their treatment. * Participants who do not have serious side effect
Primary Outcome
Patients presenting with symptoms possibly related to autoimmune reaction will be evaluated for organ specific autoimmune involvement, i.e: * Acute abdominal symptoms should be evaluated for pancreatitis, including lipase and amylase levels; * Persistent diarrhea should be evaluated for infection (c. diff). Any suspicion of colitis should be evaluated by a colonoscopy with biopsy. * Visual symptoms should be immediately evaluated by an ophthalmologist. * Generalized rash should be biopsied prio
Interventions
- DRUG Gemcitabine
- BIOLOGICAL CT-011
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2012-09 |
| Est. Completion | 2017-01 |
| Phase | Phase 2 |
Why NCT01313416 stopped before completion
NCT01313416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Gemcitabine is the first listed.
NCT01313416 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01313416 about?
NCT01313416 is a clinical study titled "Gemcitabine and CT-011 for Resected Pancreatic Cancer". Background: * In 2009, 49,096 patients were diagnosed with pancreatic cancer. Pancreatic cancer carries a poor prognosis with an overall 5-year relative survival rate of 5.6%. * Many doctors believe that individuals who have had surgery to remove pancreatic cancer should receive additional treatmen...
What is the current status of trial NCT01313416?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2012-09. Estimated completion is 2017-01.
What interventions are being tested in trial NCT01313416?
The interventions under investigation include: Gemcitabine (DRUG), CT-011 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01313416?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01313416's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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