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NCT02620865 · ClinicalTrials.gov registry record · Phase 1
BATS With in Combination With Low Dose IL-1 and GM-CSF for Advanced Pancreatic Cancer
A Phase 1 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer, sponsored by Barbara Ann Karmanos Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
- 1
- Study location
NCT02620865: Completed Phase 1 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer, sponsored by Barbara Ann Karmanos Cancer Institute.
NCT02620865 is a Phase 1 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer that has completed, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 2 participants, below the 90-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02620865, a Phase 1 study of Metastatic Pancreatic Adenocarcinoma and Stage IV Pancreatic Cancer, has completed, sponsored by Barbara Ann Karmanos Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase Ib/II trial studies the side effects and best dose of bispecific antibody armed activated T-cells when given together with aldesleukin and sargramostim and to see how well they work in treating patients with pancreatic cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Bispecific antibody armed activated T-cells are the patient's own T cells that are coated with a bispecific antibody comprising 2 antibodies chemically joined together. These antibodies have specific targets and binding properties that may give the T cells a greater ability to seek out, attach to, and kill more cancer cells.
Primary Outcome
Descriptive statistics (point and exact 90% confidence interval estimates from the resultant Kaplan-Meier curve) will be generated for OS. The median OS will be estimated on an intention-to-treat basis (using all registered patients), and on a response-evaluable basis (using all patients who completed all BAT infusions) using the Kaplan-Meier method.
Conditions Studied
Interventions
- DRUG Fluorouracil
- DRUG Irinotecan Hydrochloride
- DRUG Gemcitabine Hydrochloride
- BIOLOGICAL Aldesleukin
- BIOLOGICAL Antibody Therapy
Study Locations (1)
Michigan
- Wayne State University/Karmanos Cancer Institute - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2015-12 |
| Est. Completion | 2021-06-21 |
| Phase | Phase 1 |
What the finished NCT02620865 record still lists
NCT02620865 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 90-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target (98% lower).
The record links to 4 conditions, with Metastatic Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Fluorouracil is the first listed.
NCT02620865 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT02620865 about?
NCT02620865 is a clinical study titled "BATS With in Combination With Low Dose IL-1 and GM-CSF for Advanced Pancreatic Cancer". This phase Ib/II trial studies the side effects and best dose of bispecific antibody armed activated T-cells when given together with aldesleukin and sargramostim and to see how well they work in treating patients with pancreatic cancer that has spread from where it started to nearby tissue or lymph...
What is the current status of trial NCT02620865?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2015-12. Estimated completion is 2021-06-21.
What conditions does trial NCT02620865 study?
This clinical trial studies the following conditions: Metastatic Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer, Stage III Pancreatic Cancer, Recurrent Pancreatic Carcinoma.
What interventions are being tested in trial NCT02620865?
The interventions under investigation include: Fluorouracil (DRUG), Irinotecan Hydrochloride (DRUG), Gemcitabine Hydrochloride (DRUG), Aldesleukin (BIOLOGICAL), Antibody Therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT02620865?
This trial is sponsored by Barbara Ann Karmanos Cancer Institute, which has 139 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02620865 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02620865's enrollment target sits among peer trials
2 38th of 37 the lowest of 37 other Metastatic Pancreatic Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Pancreatic Adenocarcinoma 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.
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