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NCT01215916 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study in Patients With Solid Tumors
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT01215916: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT01215916 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01215916, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine the maximum tolerated dose (MTD) regimen for the combination therapy of LY573636 and pemetrexed that may be safely administered to patients with a solid tumor that is not amenable to curative therapy.
Primary Outcome
Based on maximum tolerated dose (MTD) in Cycle 1: highest dose where \<33% participants (pts) had dose-limiting toxicity (DLT). DLTs were adverse events (AE) possibly related to study drug or AEs that met any of National Cancer Institute's (NCI) Common Terminology Criteria for AEs (CTAE): Grade (G) 4 neutropenia lasting ≥5 days; G4 neutropenia with fever, G4 thrombocytopenia, G3 thrombocytopenia with bleeding, ≥G3 non-hematologic toxicity (except nausea/vomiting and diarrhea controlled by medica
Interventions
- DRUG Pemetrexed
- DRUG LY573636
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2008-02 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
What the finished NCT01215916 record still lists
NCT01215916 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 2 interventions - of which Pemetrexed is the first listed.
NCT01215916 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01215916 about?
NCT01215916 is a clinical study titled "A Phase 1 Study in Patients With Solid Tumors". The primary objective of this study is to determine the maximum tolerated dose (MTD) regimen for the combination therapy of LY573636 and pemetrexed that may be safely administered to patients with a solid tumor that is not amenable to curative therapy.
What is the current status of trial NCT01215916?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2008-02. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01215916?
The interventions under investigation include: Pemetrexed (DRUG), LY573636 (DRUG).
Who is sponsoring clinical trial NCT01215916?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01215916's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 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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