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COMPLETED Phase 1

A Phase 1 Multicenter Open-label Study to Evaluate the Safety Tolerability and PK of MEDI0680 (AMP-514) in Subjects With Advanced Malignancies

NCT02013804 · View on ClinicalTrials.gov ↗

Study Summary

This is a multicenter, open label, first-in-human dose-escalation study of MEDI0680 (AMP-514) to evaluate the safety, tolerability, PK, immunogenicity (IM), and antitumor activity in adult subjects with solid tumors.

Conditions Studied

Interventions

  • DRUG MEDI0680 (AMP-514)

Study Locations (6)

Connecticut

  • Research Site — New Haven

Michigan

  • Research Site — Detroit

New York

  • Research Site — The Bronx

Oregon

  • Research Site — Portland

Tennessee

  • Research Site — Nashville

Texas

  • Research Site — Houston

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2013-12-19
Est. Completion 2017-05-18
Phase Phase 1

Sponsor

MedImmune

55 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02013804

The ClinicalTrials.gov registry entry for NCT02013804 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 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MedImmune, which has 55 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 Advanced Malignancies appearing as the primary indexed condition, and to 1 intervention — of which MEDI0680 (AMP-514) 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: NCT02013804 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Connecticut, Michigan, 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 NCT02013804 about?

NCT02013804 is a clinical study titled "A Phase 1 Multicenter Open-label Study to Evaluate the Safety Tolerability and PK of MEDI0680 (AMP-514) in Subjects With Advanced Malignancies". This is a multicenter, open label, first-in-human dose-escalation study of MEDI0680 (AMP-514) to evaluate the safety, tolerability, PK, immunogenicity (IM), and antitumor activity in adult subjects with solid tumors.

What is the current status of trial NCT02013804?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2013-12-19. Estimated completion is 2017-05-18.

What conditions does trial NCT02013804 study?

This clinical trial studies the following conditions: Advanced Malignancies. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02013804?

The interventions under investigation include: MEDI0680 (AMP-514) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02013804?

This trial is sponsored by MedImmune, which has 55 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02013804 being conducted?

This trial has 6 study locations across Connecticut, Michigan, New York, Oregon, Tennessee. 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