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NCT01836432 · ClinicalTrials.gov registry record · Phase 3
Immunotherapy Study in Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer
A Phase 3 study, sponsored by NewLink Genetics Corporation.
- Terminated
- Registry status
- Phase 3
- Development phase
- 302
- Enrollment target
NCT01836432 is a Phase 3 study that was terminated before completion, run by NewLink Genetics Corporation. The registered enrollment target is 302 participants.
The verdict
NCT01836432, a Phase 3 study, was terminated before completion, sponsored by NewLink Genetics Corporation.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 302 participants
- Enrollment target
Study Summary
Unfortunately, despite the best clinical efforts and breakthroughs in biotechnology, most patients diagnosed with pancreatic cancer continue to die from the rapid progression of their disease. One primary reason for this is that the disease is typically without symptoms until significant local and/or distant spread has occurred and is often beyond the chance for cure at the time of the diagnosis. The lack of any treatment to substantially increase long term survival rates is reflected by the poor outcomes associated with this disease, specifically time to disease progression and overall survival. However, another important part of the body is now being looked at as a target for therapy against this disease - the immune system. Scientists have clearly shown that pancreatic tumor cells produce a number of defective proteins, or express normal proteins in highly uncharacteristic ways, as part of this cancer. In some cancers, these abnormalities can cause an immune response to the cancer cells much in the way one responds to infected tissue. In progressive cancers however, the immune system fails to effectively identify or respond to these abnormalities and the cancer cells are not attacked or destroyed for reasons not yet fully understood. This clinical trial proposes a new way to stimulate the immune system to recognize pancreatic cancer cells and to stimulate an immune response that destroys or blocks the growth of the cancer. This new method of treatment helps the immune system of pancreatic cancer patients to "identify" the cancerous tissue so that it can be eliminated from the body. As an example, most people are aware that patients with certain diseases may require an organ transplant to replace a damaged kidney or heart. After receiving their transplant, these patients receive special drugs because they are at great danger of having an immune response that destroys or "rejects" the transplanted organ. This "rejection" occurs when their immune system responds t
Interventions
- DRUG Capecitabine
- DRUG Gemcitabine
- DRUG FOLFIRINOX
- BIOLOGICAL Algenpantucel-L Immunotherapy
- RADIATION 5-FU Chemoradiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 2013-05 |
| Est. Completion | 2017-03-24 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01836432
The ClinicalTrials.gov registry entry for NCT01836432 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 302 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NewLink Genetics Corporation, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Capecitabine is the first listed.
NCT01836432 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01836432 about?
NCT01836432 is a clinical study titled "Immunotherapy Study in Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer". Unfortunately, despite the best clinical efforts and breakthroughs in biotechnology, most patients diagnosed with pancreatic cancer continue to die from the rapid progression of their disease. One primary reason for this is that the disease is typically without symptoms until significant local and/o...
What is the current status of trial NCT01836432?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 302 participants. The study started on 2013-05. Estimated completion is 2017-03-24.
What interventions are being tested in trial NCT01836432?
The interventions under investigation include: Capecitabine (DRUG), Gemcitabine (DRUG), FOLFIRINOX (DRUG), Algenpantucel-L Immunotherapy (BIOLOGICAL), 5-FU Chemoradiation (RADIATION).
Who is sponsoring clinical trial NCT01836432?
This trial is sponsored by NewLink Genetics Corporation, which has 31 total clinical trials registered on ClinicalTrials.gov.
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