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NCT03234712 · ClinicalTrials.gov registry record · Phase 1

A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR)

A Phase 1 study of Advanced Solid Tumors Cancer, sponsored by AbbVie.

Completed
Registry status
Phase 1
Development phase
62
Enrollment target
18
Study locations

NCT03234712 is a Phase 1 study of Advanced Solid Tumors Cancer that has completed, run by AbbVie. The registered enrollment target is 62 participants, below the 347-participant average among 9 other Advanced Solid Tumors Cancer trials with a reported enrollment target (82% lower). The trial reports 18 study locations across 13 states.

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The verdict

NCT03234712, a Phase 1 study of Advanced Solid Tumors Cancer, has completed, sponsored by AbbVie.

COMPLETED
Registry status
Phase 1
Development phase
62 participants
Enrollment target
18
Study locations

Study Summary

This is an open-label, Phase 1, dose-escalation study to determine the maximum tolerated dose (MTD) and the recommended phase two dose (RPTD), and to assess the safety, preliminary efficacy, and pharmacokinetic (PK) profile of ABBV-321 for participants with advanced solid tumors likely to overexpress the epidermal growth factor receptor (EGFR). The study will consist of 2 phases: Dose Escalation Phase and Expansion Phase.

Interventions

  • DRUG ABBV-321

Study Locations (18)

Illinois

  • Northwestern University Feinberg School of Medicine /ID# 165191 - Chicago
  • University of Chicago /ID# 166064 - Chicago
  • Northshore University Health System Dermatology Clinical Trials Unit /ID# 201095 - Skokie

California

  • The Angeles Clinic and Researc /ID# 166133 - Los Angeles
  • University of California, Davis Comprehensive Cancer Center /ID# 215012 - Sacramento

New York

  • Columbia Univ Medical Center /ID# 167184 - New York
  • Stony Brook University Hospital /ID# 216976 - Stony Brook

Victoria

  • Monash Health /ID# 217435 - Clayton
  • Austin Hospital /ID# 166137 - Heidelberg

Arkansas

  • Highlands Oncology Group /ID# 166132 - Springdale

Kentucky

  • University of Kentucky Markey Cancer Center /ID# 217665 - Lexington

Massachusetts

  • Dana-Farber Cancer Institute /ID# 212920 - Boston

Missouri

  • Washington University-School of Medicine /ID# 214955 - St Louis

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2017-10-10
Est. Completion 2021-04-14
Phase Phase 1

Sponsor

AbbVie

526 total trials

What the Registry Record Tells You About NCT03234712

The ClinicalTrials.gov registry entry for NCT03234712 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 347-participant average among 9 other Advanced Solid Tumors Cancer trials with a reported enrollment target (82% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Advanced Solid Tumors Cancer appearing as the primary indexed condition, and to 1 intervention - of which ABBV-321 is the first listed.

NCT03234712 reports 18 study locations spanning 13 distinct geographic areas - top geographies include Illinois, California, New York.

Frequently Asked Questions

What is clinical trial NCT03234712 about?

NCT03234712 is a clinical study titled "A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR)". This is an open-label, Phase 1, dose-escalation study to determine the maximum tolerated dose (MTD) and the recommended phase two dose (RPTD), and to assess the safety, preliminary efficacy, and pharmacokinetic (PK) profile of ABBV-321 for participants with advanced solid tumors likely to overexpres...

What is the current status of trial NCT03234712?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2017-10-10. Estimated completion is 2021-04-14.

What conditions does trial NCT03234712 study?

This clinical trial studies the following conditions: Advanced Solid Tumors Cancer.

What interventions are being tested in trial NCT03234712?

The interventions under investigation include: ABBV-321 (DRUG).

Who is sponsoring clinical trial NCT03234712?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03234712 being conducted?

This trial has 18 study locations across Arkansas, California, Illinois, Kentucky, Massachusetts. 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

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