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NCT01137006 · ClinicalTrials.gov registry record · Phase 1

An Open-Label, Dose-Escalation Study of IMC-20D7S In Participants With Malignant Melanoma

A Phase 1 study of Malignant Melanoma, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 1
Development phase
27
Enrollment target
2
Study locations

NCT01137006: Completed Phase 1 study of Malignant Melanoma, sponsored by Eli Lilly and Company.

NCT01137006 is a Phase 1 study of Malignant Melanoma that has completed, run by Eli Lilly and Company. The registered enrollment target is 27 participants, below the 182-participant average among 28 other Malignant Melanoma trials with a reported enrollment target (85% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01137006, a Phase 1 study of Malignant Melanoma, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 1
Development phase
27 participants
Enrollment target
2
Study locations

Study Summary

A dose-escalation study designed to determine the safety, maximum tolerated dose (MTD), anti-melanoma activity, antibody blood levels and progression-free survival (PFS) in participants with malignant melanoma receiving IMC-20D7S either every 2 weeks or every 3 weeks.

Primary Outcome

The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT) during treatment Cycle 1. A DLT was defined as any Grade 3 or above toxicity that emerged during study treatment and was clearly not attributable to malignant melanoma or co-medication and was possibly, probably, or definitely related to IMC-20D7S in the judgment of the investigator. No DLT was observed in the study; a provisional MTD was established.

Conditions Studied

Interventions

  • BIOLOGICAL IMC-20D7S (Cohort 1A)
  • BIOLOGICAL IMC-20D7S (Cohort 2A)
  • BIOLOGICAL IMC-20D7S (Cohort 3A)
  • BIOLOGICAL IMC-20D7S (Cohort 4A)
  • BIOLOGICAL IMC-20D7S (Cohort 1B)

Study Locations (2)

Massachusetts

  • ImClone Investigational Site - Boston

New York

  • ImClone Investigational Site - New York

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2010-06
Est. Completion 2012-08
Phase Phase 1
Eli Lilly and Company

1,341 total trials

What the finished NCT01137006 record still lists

NCT01137006 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 182-participant average among 28 other Malignant Melanoma trials with a reported enrollment target (85% lower).

The record links to 1 condition, with Malignant Melanoma appearing as the primary indexed condition, and to 5 interventions - of which IMC-20D7S (Cohort 1A) is the first listed.

NCT01137006 reports a single indexed study location in Massachusetts, New York.

Frequently Asked Questions

What is clinical trial NCT01137006 about?

NCT01137006 is a clinical study titled "An Open-Label, Dose-Escalation Study of IMC-20D7S In Participants With Malignant Melanoma". A dose-escalation study designed to determine the safety, maximum tolerated dose (MTD), anti-melanoma activity, antibody blood levels and progression-free survival (PFS) in participants with malignant melanoma receiving IMC-20D7S either every 2 weeks or every 3 weeks.

What is the current status of trial NCT01137006?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2010-06. Estimated completion is 2012-08.

What conditions does trial NCT01137006 study?

This clinical trial studies the following conditions: Malignant Melanoma.

What interventions are being tested in trial NCT01137006?

The interventions under investigation include: IMC-20D7S (Cohort 1A) (BIOLOGICAL), IMC-20D7S (Cohort 2A) (BIOLOGICAL), IMC-20D7S (Cohort 3A) (BIOLOGICAL), IMC-20D7S (Cohort 4A) (BIOLOGICAL), IMC-20D7S (Cohort 1B) (BIOLOGICAL).

Who is sponsoring clinical trial NCT01137006?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01137006 being conducted?

This trial has 2 study locations across Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Malignant 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 NCT01137006's enrollment target sits among peer trials

27 21st of 28 higher than 8 of 28 other Malignant Melanoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Malignant 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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Source: ClinicalTrials.gov NCT01137006, the US trial registry maintained by the National Library of Medicine. NCT01137006 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.