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COMPLETED Phase 1

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

NCT01137006 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

Eli Lilly and Company

704 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01137006

The ClinicalTrials.gov registry entry for NCT01137006 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 704 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01137006 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Massachusetts, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01137006?

This trial is sponsored by Eli Lilly and Company, which has 704 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial