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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.

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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

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

FieldValue
Enrollment Target 173 participants
Start Date 2010-08-05
Est. Completion 2018-02-08
Phase Phase 1
Eisai

287 total trials

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.

Similar trials for Metastatic Renal Cell Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01136733, the US trial registry maintained by the National Library of Medicine. NCT01136733 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.