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NCT01136733 · ClinicalTrials.gov registry record · Phase 1
A Study of E7080 Alone, and in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Treatment
A Phase 1 study of Metastatic Renal Cell Carcinoma, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 173
- Enrollment target
- 20
- Study locations
NCT01136733: Completed Phase 1 study of Metastatic Renal Cell Carcinoma, sponsored by Eisai.
NCT01136733 is a Phase 1 study of Metastatic Renal Cell Carcinoma that has completed, run by Eisai. The registered enrollment target is 173 participants, above the 139-participant average among 37 other Metastatic Renal Cell Carcinoma trials with a reported enrollment target (24% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01136733, a Phase 1 study of Metastatic Renal Cell Carcinoma, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 173 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label, multicenter, Phase 1b/2 study of lenvatinib alone and in combination with everolimus in subjects with unresectable advanced or metastatic renal cell carcinoma following one prior VEGF-targeted treatment.
Primary Outcome
A DLT was defined as either a treatment-related failure to administer greater than or equal to (\>=) 75% of the planned dosage of lenvatinib/everolimus or a specific National Cancer Institute Common Toxicity Criteria (NCI CTC) \>= Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care daily living activities) hematologic or nonhematologic toxicities considered to be possibly relate
Conditions Studied
Interventions
- DRUG Everolimus
- DRUG Lenvatinib
Study Locations (20)
Other
- - Brno
- - Olomouc
- - Prague
- - Gdansk
- - Lodz
- - Szczecin
California
- - Orange
- - San Diego
Maryland
- - Annapolis
- - Bethesda
Arizona
- - Tucson
Florida
- - Tampa
Illinois
- - Joliet
Kentucky
- - Louisville
Massachusetts
- - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2010-08-05 |
| Est. Completion | 2018-02-08 |
| Phase | Phase 1 |
What the finished NCT01136733 record still lists
NCT01136733 is an interventional study that assigns participants to a tested intervention. The registered 173 participants enrollment target is mid-sized for trials with a published cap, above the 139-participant average among 37 other Metastatic Renal Cell Carcinoma trials with a reported enrollment target (24% higher).
The record links to 1 condition, with Metastatic Renal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Everolimus is the first listed.
NCT01136733 names 20 study sites across 13 states, led by Other, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT01136733 about?
NCT01136733 is a clinical study titled "A Study of E7080 Alone, and in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Treatment". This is an open-label, multicenter, Phase 1b/2 study of lenvatinib alone and in combination with everolimus in subjects with unresectable advanced or metastatic renal cell carcinoma following one prior VEGF-targeted treatment.
What is the current status of trial NCT01136733?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 173 participants. The study started on 2010-08-05. Estimated completion is 2018-02-08.
What conditions does trial NCT01136733 study?
This clinical trial studies the following conditions: Metastatic Renal Cell Carcinoma.
What interventions are being tested in trial NCT01136733?
The interventions under investigation include: Everolimus (DRUG), Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT01136733?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01136733 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01136733's enrollment target sits among peer trials
173 9th of 37 higher than 29 of 37 other Metastatic Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Renal Cell Carcinoma 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.
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