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NCT01133977 · ClinicalTrials.gov registry record · Phase 1

E7080 (Lenvatinib) in Combination With Dacarbazine Versus Dacarbazine Alone as First Line Therapy in Patients With Stage IV Melanoma

A Phase 1 study of Stage IV Melanoma, sponsored by Eisai.

Completed
Registry status
Phase 1
Development phase
97
Enrollment target
20
Study locations

NCT01133977: Completed Phase 1 study of Stage IV Melanoma, sponsored by Eisai.

NCT01133977 is a Phase 1 study of Stage IV Melanoma that has completed, run by Eisai. The registered enrollment target is 97 participants, above the 39-participant average among 13 other Stage IV Melanoma trials with a reported enrollment target (149% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01133977, a Phase 1 study of Stage IV Melanoma, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 1
Development phase
97 participants
Enrollment target
20
Study locations

Study Summary

Primary: * Phase Ib: To define the safety, tolerability and maximum tolerated dose (MTD) of lenvatinib administered in combination with dacarbazine. * Phase II: To evaluate the safety and tolerability of lenvatinib administered in combination with dacarbazine, compared with dacarbazine alone. Secondary: -Phase II: To make a preliminary assessment of the efficacy of lenvatinib administered in combination with dacarbazine, compared with dacarbazine alone.

Primary Outcome

DLTs were defined as clinically significant adverse events (AEs) occurring less than or equal to 21 days after commencing study treatment and considered by the Investigator to be possibly or probably related to study treatment.

Conditions Studied

Stage IV Melanoma

Interventions

  • DRUG Lenvatinib
  • DRUG Dacarbazine

Study Locations (20)

Other

  • - Berlin
  • - Berlin
  • - Berlin
  • - Heidelberg
  • - München
  • - Bari
  • - Milan
  • - Milian
  • - Naples
  • - Siena
  • - Barcelona
  • - Madrid
  • - Madrid
  • - Madrid
  • - Valenica

Maryland

  • - Hagerstown

New York

  • - Albany

South Carolina

  • - Greenville

Texas

  • - Dallas

Virginia

  • - Norfolk

Trial Details

FieldValue
Enrollment Target 97 participants
Start Date 2010-04
Est. Completion 2014-11
Phase Phase 1
Eisai

287 total trials

What the finished NCT01133977 record still lists

NCT01133977 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, above the 39-participant average among 13 other Stage IV Melanoma trials with a reported enrollment target (149% higher).

The record links to 1 condition, with Stage IV Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Lenvatinib is the first listed.

NCT01133977 names 20 study sites across 6 states, led by Other, Maryland, New York.

Frequently Asked Questions

What is clinical trial NCT01133977 about?

NCT01133977 is a clinical study titled "E7080 (Lenvatinib) in Combination With Dacarbazine Versus Dacarbazine Alone as First Line Therapy in Patients With Stage IV Melanoma". Primary: * Phase Ib: To define the safety, tolerability and maximum tolerated dose (MTD) of lenvatinib administered in combination with dacarbazine. * Phase II: To evaluate the safety and tolerability of lenvatinib administered in combination with dacarbazine, compared with dacarbazine alone. Seco...

What is the current status of trial NCT01133977?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 97 participants. The study started on 2010-04. Estimated completion is 2014-11.

What conditions does trial NCT01133977 study?

This clinical trial studies the following conditions: Stage IV Melanoma.

What interventions are being tested in trial NCT01133977?

The interventions under investigation include: Lenvatinib (DRUG), Dacarbazine (DRUG).

Who is sponsoring clinical trial NCT01133977?

This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01133977 being conducted?

This trial has 20 study locations across Maryland, New York, South Carolina, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Stage IV Melanoma

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 NCT01133977's enrollment target sits among peer trials

97 1st of 13 higher than 13 of 13 other Stage IV Melanoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stage IV Melanoma 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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Related registry views

Source: ClinicalTrials.gov NCT01133977, the US trial registry maintained by the National Library of Medicine. NCT01133977 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.