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NCT00921310 · ClinicalTrials.gov registry record · Phase 1
Temsirolimus and Pemetrexed for Recurrent or Refractory Non-Small Cell Lung Cancer
A Phase 1 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT00921310: Clinical Trial Phase 1 study, sponsored by Washington University School of Medicine.
NCT00921310 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00921310, a Phase 1 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of the combination of temsirolimus and pemetrexed, as well as the response rate. The starting dose (Dose Level 1) and schedule of pemetrexed will be 500 mg/m\^2 given every 3 weeks and the starting dose (Dose Level 1) for temsirolimus will be 15 mg given weekly for 3 weeks, to complete 1 cycle. In subsequent cohorts, dose will be escalated or de-escalated. Enrollment to each cohort is based on toxicity experienced at that dose level.
Primary Outcome
The starting dose and schedule of pemetrexed will be 500 mg/m2 given every 3 weeks and the starting dose for temsirolimus will be 15 mg given weekly for 3 weeks, to complete 1 cycle. In subsequent cohorts, dose will be escalated or de-escalated. Enrollment to each cohort is based on toxicity experienced at that dose level. The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort experience dose-limiting toxicity during the fir
Interventions
- DRUG Pemetrexed
- DRUG Temsirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2009-09 |
| Est. Completion | 2016-04 |
| Phase | Phase 1 |
Why NCT00921310 stopped before completion
NCT00921310 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Pemetrexed is the first listed.
NCT00921310 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00921310 about?
NCT00921310 is a clinical study titled "Temsirolimus and Pemetrexed for Recurrent or Refractory Non-Small Cell Lung Cancer". To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of the combination of temsirolimus and pemetrexed, as well as the response rate. The starting dose (Dose Level 1) and schedule of pemetrexed will be 500 mg/m\^2 given every 3 weeks and the starting dose (Dose Level 1) f...
What is the current status of trial NCT00921310?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2009-09. Estimated completion is 2016-04.
What interventions are being tested in trial NCT00921310?
The interventions under investigation include: Pemetrexed (DRUG), Temsirolimus (DRUG).
Who is sponsoring clinical trial NCT00921310?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00921310's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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