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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 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 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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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.

Conditions Studied

Colorectal Cancer Pancreatic Cancer Pancreatic Neoplasm Colon Carcinoma Cancer of Pancreas Cancer of Colon Malignant Neoplasm of Large Intestine Malignant Tumor of Colon

Interventions

  • DRUG FOLFOX6
  • BIOLOGICAL EGFRBi armed ATC Infusions

Study Locations (1)

Michigan

  • Barbara Ann Karmanos Cancer Institute - Detroit

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2011-08-17
Est. Completion 2020-10-19
Phase Phase 1

Sponsor

Barbara Ann Karmanos Cancer Institute

139 total trials

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What the Registry Record Tells You About NCT01420874

The ClinicalTrials.gov registry entry for NCT01420874 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Barbara Ann Karmanos Cancer Institute, which has 139 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.