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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 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 190 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01285037
The ClinicalTrials.gov registry entry for NCT01285037 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 190 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT01285037 reports 0 study locations.
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.
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