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NCT01258348 · ClinicalTrials.gov registry record · Phase 1
A Phase 1b Trial in Patients With Renal Cell Cancer
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT01258348: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT01258348 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01258348, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
The purpose of this study is to determine a safe dose of LY573636-sodium to be given in combination with sunitinib to patients with metastatic Renal Cell Carcinoma (RCC) and to determine any side effects that may be associated with LY573636-sodium and sunitinib combination in this patient population. The tumor response rate will also be assessed.
Primary Outcome
Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD is the highest dose with \<33% of participants having a dose-limiting toxicity (DLT) during the first 6-week cycle of treatment. DLT is an adverse event (AE) that is likely related to study drug or combination and fulfills any 1 of the following: Common Terminology Criteria for AE (CTCAE, Version 3.0) Grade (Gr) 4 neutropenia lasting ≥5 days; Gr 4 neutropenia with fever; Gr 4 thrombocytopenia; Gr ≥3 thrombocytopenia wit
Interventions
- DRUG Sunitinib
- DRUG Drug: LY573636-sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2008-07 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
What the finished NCT01258348 record still lists
NCT01258348 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Sunitinib is the first listed.
NCT01258348 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01258348 about?
NCT01258348 is a clinical study titled "A Phase 1b Trial in Patients With Renal Cell Cancer". The purpose of this study is to determine a safe dose of LY573636-sodium to be given in combination with sunitinib to patients with metastatic Renal Cell Carcinoma (RCC) and to determine any side effects that may be associated with LY573636-sodium and sunitinib combination in this patient population...
What is the current status of trial NCT01258348?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2008-07. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01258348?
The interventions under investigation include: Sunitinib (DRUG), Drug: LY573636-sodium (DRUG).
Who is sponsoring clinical trial NCT01258348?
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 NCT01258348's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 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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