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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: Completed Phase 1 study of Advanced Solid Tumors Cancer, sponsored by AbbVie.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCt) for ABBV-321
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2017-10-10 |
| Est. Completion | 2021-04-14 |
| Phase | Phase 1 |
What the finished NCT03234712 record still lists
NCT03234712 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 347-participant average among 9 other Advanced Solid Tumors Cancer trials with a reported enrollment target (82% lower).
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 lists 18 locations in 13 states (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.
Learn More About Clinical Trials
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Where NCT03234712's enrollment target sits among peer trials
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