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NCT00508144 · ClinicalTrials.gov registry record · Phase 2

Single Agent Alimta in Poor Performance Status in Non-small Cell Lung Cancer

A Phase 2 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
64
Enrollment target

NCT00508144: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT00508144 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 64 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00508144, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
64 participants
Enrollment target

Study Summary

The goal of this clinical research study is to learn how effective the drug pemetrexed (ALIMTA®) is in treating advanced NSCLC in patients with poor performance status (PS) (inability to perform every day activities without difficulty). Objectives: Primary Objectives: * PS = 2 cohort: Response * PS = 3 cohort: Descriptive Secondary Objectives: * Tolerability of single agent pemetrexed (Alimta®) in PS = 3 NSCLC patients * Improved symptoms (both cohorts) * Molecular Correlative studies (both cohorts) * Overall survival * Time to progression

Primary Outcome

Complete Response (CR): Complete disappearance of all measurable \& non-measurable disease; No new lesions; No disease related symptoms; Normalization of markers \& other abnormal lab values. Partial Response (PR): Applies only to those with at least one measurable lesion. \>/= 30% decrease under baseline of sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions assessed using same techniques

Interventions

  • DRUG Alimta

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2005-09
Est. Completion 2015-12
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00508144 record still lists

NCT00508144 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower).

The record links to 0 conditions, and to 1 intervention - of which Alimta is the first listed.

NCT00508144 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00508144 about?

NCT00508144 is a clinical study titled "Single Agent Alimta in Poor Performance Status in Non-small Cell Lung Cancer". The goal of this clinical research study is to learn how effective the drug pemetrexed (ALIMTA®) is in treating advanced NSCLC in patients with poor performance status (PS) (inability to perform every day activities without difficulty). Objectives: Primary Objectives: * PS = 2 cohort: Response * ...

What is the current status of trial NCT00508144?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2005-09. Estimated completion is 2015-12.

What interventions are being tested in trial NCT00508144?

The interventions under investigation include: Alimta (DRUG).

Who is sponsoring clinical trial NCT00508144?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00508144's enrollment target sits among peer trials

64 996th of 2000 higher than 992 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00508144, the US trial registry maintained by the National Library of Medicine. NCT00508144 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.