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NCT00923741 · ClinicalTrials.gov registry record · Phase 1

Effect of Talactoferrin in Adults With Non-Small Cell Lung Cancer

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
10
Enrollment target

NCT00923741: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT00923741 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00923741, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
10 participants
Enrollment target

Study Summary

Background: More effective therapies are needed for patients with non-small cell lung cancer (NSCLC) whose disease has advanced or spread beyond the original site following standard treatment. Talactoferrin is a genetically engineered form of the human protein lactoferrin, found in body secretions such as breast milk, tears and saliva. In previous studies, talactoferrin improved life span in patients with NSCLC without causing toxic side effects. Objectives: To examine the effects of talactoferrin on the immune system and determine its effectiveness in treating NSCLC. Eligibility: Patients with advanced NSCLC who have tissue type HLA-A2 and whose cancer has gotten worse following at least one course of treatment. Design: Talactoferrin treatment: Patients take liquid talactoferrin twice a day for 12 weeks, followed by 2 weeks off the drug. Treatment may continue in these 14-week cycles depending on the drug side effects and the response of the tumor. Evaluations: Patients are evaluated at the clinic with a physical examination, check of vital signs and blood tests every 3 weeks. CT scans: Patients have CT scans to monitor disease before starting treatment, again at 6 weeks and 12 weeks and then every 12 weeks during the duration of treatment. Apheresis: Quantities of white blood cells called lymphocytes are collected through a procedure called apheresis in order to measure the immune response to treatment. In this procedure, blood is collected through a needle placed in a vein in the arm (similar to donating blood) and circulated through a cell separator machine. The lymphocytes are extracted and the rest of the blood is returned to the body through the same needle.

Interventions

  • PROCEDURE Apheresis
  • DRUG Talactoferrin

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2008-06-19
Est. Completion 2010-02-01
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00923741 record still lists

NCT00923741 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 2 interventions - of which Apheresis is the first listed.

NCT00923741 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00923741 about?

NCT00923741 is a clinical study titled "Effect of Talactoferrin in Adults With Non-Small Cell Lung Cancer". Background: More effective therapies are needed for patients with non-small cell lung cancer (NSCLC) whose disease has advanced or spread beyond the original site following standard treatment. Talactoferrin is a genetically engineered form of the human protein lactoferrin, found in body secretions...

What is the current status of trial NCT00923741?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2008-06-19. Estimated completion is 2010-02-01.

What interventions are being tested in trial NCT00923741?

The interventions under investigation include: Apheresis (PROCEDURE), Talactoferrin (DRUG).

Who is sponsoring clinical trial NCT00923741?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00923741's enrollment target sits among peer trials

10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00923741, the US trial registry maintained by the National Library of Medicine. NCT00923741 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.