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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 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.

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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.

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

Sponsor

Eisai

287 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01133977

The ClinicalTrials.gov registry entry for NCT01133977 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 39-participant average among 13 other Stage IV Melanoma trials with a reported enrollment target (149% higher). The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.