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NCT00383331 · ClinicalTrials.gov registry record · Phase 2

Pemetrexed and Gemcitabine Every 14 Days Versus Every 21 Days in Advanced Non Small Cell Lung Cancer

A Phase 2 study, sponsored by Eli Lilly and Company.

Terminated
Registry status
Phase 2
Development phase
19
Enrollment target

NCT00383331: Clinical Trial Phase 2 study, sponsored by Eli Lilly and Company.

NCT00383331 is a Phase 2 study that was terminated before completion, run by Eli Lilly and Company. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00383331, a Phase 2 study, was terminated before completion, sponsored by Eli Lilly and Company.

TERMINATED
Registry status
Phase 2
Development phase
19 participants
Enrollment target

Study Summary

This study is designed to evaluate Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8 every 21 days (Arm A) and Pemetrexed and Gemcitabine Day 1 every 14 days (Arm B) in patients with NSCLC. Each agent and sequence has well demonstrated antitumor activity respectively in patients with locally advanced or metastatic NSCLC. Therefore, it is reasonable to investigate the most optimal schedule for this combination, and which combination is associated with the most anti-tumor activity in the phase II arena.

Primary Outcome

Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

Interventions

  • DRUG Pemetrexed
  • DRUG Gemcitabine

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2007-02
Est. Completion 2008-01
Phase Phase 2
Eli Lilly and Company

1,341 total trials

Why NCT00383331 stopped before completion

NCT00383331 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).

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

NCT00383331 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00383331 about?

NCT00383331 is a clinical study titled "Pemetrexed and Gemcitabine Every 14 Days Versus Every 21 Days in Advanced Non Small Cell Lung Cancer". This study is designed to evaluate Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8 every 21 days (Arm A) and Pemetrexed and Gemcitabine Day 1 every 14 days (Arm B) in patients with NSCLC. Each agent and sequence has well demonstrated antitumor activity respectively in patients with lo...

What is the current status of trial NCT00383331?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2007-02. Estimated completion is 2008-01.

What interventions are being tested in trial NCT00383331?

The interventions under investigation include: Pemetrexed (DRUG), Gemcitabine (DRUG).

Who is sponsoring clinical trial NCT00383331?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00383331's enrollment target sits among peer trials

19 1894th of 2000 higher than 103 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 NCT00383331, the US trial registry maintained by the National Library of Medicine. NCT00383331 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.