Trials / Terminated
TerminatedNCT02365662
A Study Evaluating Safety and Pharmacokinetics of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor
A Phase 1 Study of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, Phase I, dose escalation study to determine the recommended Phase 2 dose, maximum tolerated dose, and evaluate the safety and pharmacokinetic profile of ABBV-221 in participants with advanced solid tumors likely to exhibit elevated levels of Epidermal Growth Factor Receptor (EGFR).
Conditions
- Head and Neck Squamous Cell Carcinoma
- Non-small Cell Lung Cancer
- Triple Negative Breast Cancer
- Colorectal Carcinoma
- Glioblastoma Multiforme
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABBV-221 | ABBV-221 will be given either every 3 weeks or 2 weeks on, 1 week off or weekly dosing by intravenous infusion approximately over 30 minutes to 3 hours. This is a dose escalation study, therefore the dose of ABBV-221 will change throughout the study. |
Timeline
- Start date
- 2015-01-09
- Primary completion
- 2018-03-15
- Completion
- 2018-03-15
- First posted
- 2015-02-19
- Last updated
- 2018-03-30
Locations
5 sites across 2 countries: United States, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02365662. Inclusion in this directory is not an endorsement.