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NCT01505166 · ClinicalTrials.gov registry record · Phase 2
Randomized Phase II Adjuvant Chemotherapy ± FANG™ in Colorectal Carcinoma With Liver Metastases
A Phase 2 study, sponsored by Gradalis.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT01505166 is a Phase 2 study that was terminated before completion, run by Gradalis. The registered enrollment target is 3 participants.
The verdict
NCT01505166, a Phase 2 study, was terminated before completion, sponsored by Gradalis.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
Preliminary studies with a variety of vaccines suggest target accessibility (potential immunogenicity) in a variety of solid tumors to immune directed approaches. In an effort to overcome limitations of immunostimulatory cancer vaccines, Gradalis has designed a novel autologous vaccine to address inability to fully identify cancer associated antigens, antigen recognition by the immune system (i.e. antigen--\>immunogen), effector potency, and cancer-induced resistance. In an effort to overcome limitations of immunostimulatory cancer vaccines, we designed a novel dual-modulatory autologous whole cell vaccine, Vigil™, incorporating the rhGMCSF transgene and the bifunctional shRNAfurin (to block proprotein conversion to active TGFb1 and b2) to 1) address the inability to fully identify cancer associated antigens, 2) effect antigen recognition by the immune system, 3) enhance effector potency, and 4) subvert endogenous cancer-induced immune resistance. We have also completed the Phase I assessment of Vigil™ vaccine in 30 advanced solid tumor patients (1.0 x 10\^7 cells/injection/month for a maximum of 12 vaccinations) who have not experienced any significant adverse effects following 144 vaccinations, including 6 patients with colorectal carcinoma. Plasmid functionality, immune biomarker response, and preliminary evidence of anticancer activity have been observed. This is a two-part Phase II study of the Vigil™ autologous vaccine. Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10\^7 cells/injection; maximum of 12 vaccinations). Part 2 of the study will be a randomized Phase II study of sandwich or adjuvant chemotherapy and intradermal autologous Vigil™ cancer vaccine (1.0 x 10\^7 cells/injection; maximum of 12 vaccinations) versus sandwich or adjuvant chemotherapy and placebo in patients with colorectal carcinoma with either synchronous or metachronous liver metastases (CLM +/= pulmonary metastase
Interventions
- DRUG Placebo
- BIOLOGICAL Vigil™ Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2012-03 |
| Est. Completion | 2016-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01505166
The ClinicalTrials.gov registry entry for NCT01505166 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gradalis, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01505166 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01505166 about?
NCT01505166 is a clinical study titled "Randomized Phase II Adjuvant Chemotherapy ± FANG™ in Colorectal Carcinoma With Liver Metastases". Preliminary studies with a variety of vaccines suggest target accessibility (potential immunogenicity) in a variety of solid tumors to immune directed approaches. In an effort to overcome limitations of immunostimulatory cancer vaccines, Gradalis has designed a novel autologous vaccine to address in...
What is the current status of trial NCT01505166?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2012-03. Estimated completion is 2016-08.
What interventions are being tested in trial NCT01505166?
The interventions under investigation include: Placebo (DRUG), Vigil™ Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01505166?
This trial is sponsored by Gradalis, which has 13 total clinical trials registered on ClinicalTrials.gov.
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