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NCT01957280 · ClinicalTrials.gov registry record · Phase 1

Study to Assess Pharmacokinetics, Immunogenicity and Safety/Tolerability of Patritumab (U3-1287)

A Phase 1 study of Solid Tumors, sponsored by Daiichi Sankyo.

Completed
Registry status
Phase 1
Development phase
17
Enrollment target
3
Study locations

NCT01957280 is a Phase 1 study of Solid Tumors that has completed, run by Daiichi Sankyo. The registered enrollment target is 17 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (94% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT01957280, a Phase 1 study of Solid Tumors, has completed, sponsored by Daiichi Sankyo.

COMPLETED
Registry status
Phase 1
Development phase
17 participants
Enrollment target
3
Study locations

Study Summary

The purpose of this study is to assess the PK, safety, and tolerability of patritumab produced by a new manufacturing process (denoted as "Process 2 patritumab"). The data from this study will allow Process 2 patritumab to be compared to Process 1 patritumab to allow for any dose adjustments, if needed, and to bridge data from studies previously conducted with Process 1 patritumab to studies to be conducted with Process 2 patritumab. The hypothesis for this study is that the pharmacokinetics of Process 2 patritumab will be comparable to those of Process 1 patritumab.

Conditions Studied

Solid Tumors

Interventions

  • DRUG patritumab

Study Locations (3)

Florida

  • - Tampa

Oklahoma

  • - Oklahoma City

Texas

  • - San Antonio

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2013-06
Est. Completion 2014-04
Phase Phase 1

Sponsor

Daiichi Sankyo

236 total trials

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What the Registry Record Tells You About NCT01957280

The ClinicalTrials.gov registry entry for NCT01957280 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (94% lower). The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which patritumab is the first listed.

NCT01957280 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Florida, Oklahoma, Texas.

Frequently Asked Questions

What is clinical trial NCT01957280 about?

NCT01957280 is a clinical study titled "Study to Assess Pharmacokinetics, Immunogenicity and Safety/Tolerability of Patritumab (U3-1287)". The purpose of this study is to assess the PK, safety, and tolerability of patritumab produced by a new manufacturing process (denoted as "Process 2 patritumab"). The data from this study will allow Process 2 patritumab to be compared to Process 1 patritumab to allow for any dose adjustments, if nee...

What is the current status of trial NCT01957280?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2013-06. Estimated completion is 2014-04.

What conditions does trial NCT01957280 study?

This clinical trial studies the following conditions: Solid Tumors.

What interventions are being tested in trial NCT01957280?

The interventions under investigation include: patritumab (DRUG).

Who is sponsoring clinical trial NCT01957280?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01957280 being conducted?

This trial has 3 study locations across Florida, Oklahoma, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.