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NCT01285037 · ClinicalTrials.gov registry record · Phase 1
A Study of LY2801653 in Advanced Cancer
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 190
- Enrollment target
NCT01285037: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT01285037 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 190 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (217% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01285037, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 190 participants
- Enrollment target
Study Summary
Part A- The purpose of this study is to determine a safe dose of LY2801653 to be given to participants with advanced cancer and to determine any side effects that may be associated with LY2801653 in this participant population. Efficacy measures will be used to assess the activity of LY2801653. Part B- The dose determined in Part A will be used along with efficacy measures to assess the activity of LY2801653 in participants with adenocarcinoma of the colon or rectum, head and neck squamous cell carcinoma (HNSCC), uveal melanoma with liver metastasis, and cholangiocarcinoma. Part C - the objective of Part C is to determine a recommended Phase 2 dose of LY2801653 that may be safely given to participants with HNSCC when taken with standard doses of cetuximab Part D - the objective of Part D is to determine a recommended Phase 2 dose of LY2801653 that may be safely given to participants with cholangiocarcinoma when taken with a standard dose of cisplatin. Part E - the objective of Part E is to determine a recommended Phase 2 dose of LY2801653 that may be safely given to participants with cholangiocarcinoma when taken with gemcitabine plus cisplatin. Part F - the objective of Part F is to determine a recommended Phase 2 dose of LY2801653 that may be safely given to participants with gastric cancer when taken with ramucirumab.
Interventions
- DRUG Cisplatin
- DRUG Cetuximab
- DRUG Gemcitabine
- DRUG Ramucirumab
- DRUG LY2801653
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2009-09-09 |
| Est. Completion | 2017-09-11 |
| Phase | Phase 1 |
What the finished NCT01285037 record still lists
NCT01285037 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (217% higher).
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT01285037 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01285037 about?
NCT01285037 is a clinical study titled "A Study of LY2801653 in Advanced Cancer". Part A- The purpose of this study is to determine a safe dose of LY2801653 to be given to participants with advanced cancer and to determine any side effects that may be associated with LY2801653 in this participant population. Efficacy measures will be used to assess the activity of LY2801653. Par...
What is the current status of trial NCT01285037?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 190 participants. The study started on 2009-09-09. Estimated completion is 2017-09-11.
What interventions are being tested in trial NCT01285037?
The interventions under investigation include: Cisplatin (DRUG), Cetuximab (DRUG), Gemcitabine (DRUG), Ramucirumab (DRUG), LY2801653 (DRUG).
Who is sponsoring clinical trial NCT01285037?
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 NCT01285037's enrollment target sits among peer trials
190 284th of 2000 higher than 1,713 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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