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NCT01420874 · ClinicalTrials.gov registry record · Phase 1
Anti-CD3 x Anti-Erbitux® Armed Activated T Cells (Phase Ib) for Gastrointestinal (GI Cancer)
A Phase 1 study of Colorectal Cancer and Pancreatic Cancer, sponsored by Barbara Ann Karmanos Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT01420874: Completed Phase 1 study of Colorectal Cancer and Pancreatic Cancer, sponsored by Barbara Ann Karmanos Cancer Institute.
NCT01420874 is a Phase 1 study of Colorectal Cancer and Pancreatic Cancer that has completed, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 15 participants, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01420874, a Phase 1 study of Colorectal Cancer and Pancreatic Cancer, has completed, sponsored by Barbara Ann Karmanos Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is for the participant to give their own T cells (a type of blood cell in the body that can fight infections and possibly cancer) to them after they have been removed, grown in a lab, and then coated with an experimental drug. This study will determine the highest dose of EGFR2Bi coated T cells that can be given without causing severe side effects. Initially a group of 3 participants will receive the same dose of study drug. If no serious side effects occur, the next group of participants will receive a slightly higher dose of study agent. The following groups of participants will receive higher doses of the study drug until a dose is reached where there are unacceptable side effects and maximum tolerated dose is found, or the planned highest dose level is reached with no side effects.
Primary Outcome
Participants will be assessed for changes in lab values (CBC, Sodium, potassium, calcium, magnesium, chloride, bicarbonate, glucose,BUN, creatinine, total Protein, albumin, total bilirubin, ALP, AST,ALT, CEA or CA 19-9.
Conditions Studied
Interventions
- DRUG FOLFOX6
- BIOLOGICAL EGFRBi armed ATC Infusions
Study Locations (1)
Michigan
- Barbara Ann Karmanos Cancer Institute - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2011-08-17 |
| Est. Completion | 2020-10-19 |
| Phase | Phase 1 |
What the finished NCT01420874 record still lists
NCT01420874 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (99% lower).
The record links to 8 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions - of which FOLFOX6 is the first listed.
NCT01420874 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT01420874 about?
NCT01420874 is a clinical study titled "Anti-CD3 x Anti-Erbitux® Armed Activated T Cells (Phase Ib) for Gastrointestinal (GI Cancer)". The purpose of this research study is for the participant to give their own T cells (a type of blood cell in the body that can fight infections and possibly cancer) to them after they have been removed, grown in a lab, and then coated with an experimental drug. This study will determine the highest...
What is the current status of trial NCT01420874?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2011-08-17. Estimated completion is 2020-10-19.
What conditions does trial NCT01420874 study?
This clinical trial studies the following conditions: Colorectal Cancer, Pancreatic Cancer, Pancreatic Neoplasm, Colon Carcinoma, Cancer of Pancreas.
What interventions are being tested in trial NCT01420874?
The interventions under investigation include: FOLFOX6 (DRUG), EGFRBi armed ATC Infusions (BIOLOGICAL).
Who is sponsoring clinical trial NCT01420874?
This trial is sponsored by Barbara Ann Karmanos Cancer Institute, which has 139 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01420874 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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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01420874's enrollment target sits among peer trials
15 361st of 381 higher than 20 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer 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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