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NCT01695005 · ClinicalTrials.gov registry record · Phase 1
A Study of LY3039478 in Participants With Advanced Cancer
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 247
- Enrollment target
NCT01695005: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT01695005 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 247 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (312% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01695005, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 247 participants
- Enrollment target
Study Summary
The purpose of this study is to find a recommended dose level of LY3039478 that can safely be taken by participants with advanced cancer or cancer that has spread to other parts of the body, including but not limited to lymphoma. The study will also explore changes to various markers in blood cells and tissue. Finally, the study will help to document any tumor activity this drug may have.
Primary Outcome
DLT was defined as an adverse event (AE) during Cycle 1 (Up to 28 Days) that was related to LY3039478 and fulfilled any 1 of the following criterion using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI-CTCAE v 4.0): CTCAE Grade 3 non-hematological toxicity with a few exceptions, CTCAE Grade 4 hematological toxicity of greater than 5 days duration, any febrile neutropenia,Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia, Any other
Interventions
- DRUG Prednisone
- DRUG LY3039478
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 247 participants |
| Start Date | 2012-10 |
| Est. Completion | 2018-06-26 |
| Phase | Phase 1 |
What the finished NCT01695005 record still lists
NCT01695005 is an interventional study that assigns participants to a tested intervention. The registered 247 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 (312% higher).
The record links to 0 conditions, and to 2 interventions - of which Prednisone is the first listed.
NCT01695005 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01695005 about?
NCT01695005 is a clinical study titled "A Study of LY3039478 in Participants With Advanced Cancer". The purpose of this study is to find a recommended dose level of LY3039478 that can safely be taken by participants with advanced cancer or cancer that has spread to other parts of the body, including but not limited to lymphoma. The study will also explore changes to various markers in blood cells ...
What is the current status of trial NCT01695005?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 247 participants. The study started on 2012-10. Estimated completion is 2018-06-26.
What interventions are being tested in trial NCT01695005?
The interventions under investigation include: Prednisone (DRUG), LY3039478 (DRUG).
Who is sponsoring clinical trial NCT01695005?
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 NCT01695005's enrollment target sits among peer trials
247 187th of 2000 higher than 1,813 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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