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
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|ClinicalTrials.gov Identifier: NCT02365662|
Recruitment Status : Terminated (Safety)
First Posted : February 19, 2015
Last Update Posted : March 30, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Squamous Cell Carcinoma Non-small Cell Lung Cancer Triple Negative Breast Cancer Colorectal Carcinoma Glioblastoma Multiforme||Drug: ABBV-221||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor|
|Actual Study Start Date :||January 9, 2015|
|Actual Primary Completion Date :||March 15, 2018|
|Actual Study Completion Date :||March 15, 2018|
Experimental: Arm 1
Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor
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.
- Number of participants with adverse events [ Time Frame: Measured for approximately 4 years ]Adverse event monitoring will be performed during the study
- Maximum Plasma Concentration (Cmax) of ABBV-221 [ Time Frame: Blood samples will be collected before infusion (0 hour, pre-dose) on Cycle 1 Day 1 (C1D1), C1D2, C1D3, C1D5, C1D8, C1D15, C2D1, C3D1, C3D2, C3D3, C3D5, C3D8, C3D15, every 2 cycles starting with Cycle 5, and at the final visit (approximately 2 years). ]The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the plasma after administration in a dosing interval.
- Area Under the Plasma Concentration-time Curve from 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-221 [ Time Frame: Blood samples will be collected before infusion (0 hour, pre-dose) on Cycle 1 Day 1 (C1D1), C1D2, C1D3, C1D5, C1D8, C1D15, C2D1, C3D1, C3D2, C3D3, C3D5, C3D8, C3D15, every 2 cycles starting with Cycle 5, and at the final visit (approximately 2 years). ]The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma.
- Maximum tolerated dose of ABBV-221 [ Time Frame: Up to 2 years from first dose of study drug. ]The highest dose level at which less than 2 of 6 participants or less than 33% of (if cohort is expanded beyond 6) participants experience a dose limiting toxicity.
- Area Under the Plasma Concentration-time Curve of ABBV-221 [ Time Frame: Blood samples will be collected before infusion (0 hour, pre-dose) on Cycle 1 Day 1 (C1D1), C1D2, C1D3, C1D5, C1D8, C1D15, C2D1, C3D1, C3D2, C3D3, C3D5, C3D8, C3D15, every 2 cycles starting with Cycle 5, and at the final visit (approximately 2 years). ]The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma.
- Recommended Phase 2 dose of ABBV-221 [ Time Frame: 1 day of study drug administration within the 21-day cycle at the designated cohort dose ]If a maximum tolerated dose (MTD) is reached, the recommended Phase 2 dose (RPTD) of ABBV-221 will not be a dose higher than the defined MTD, and will be selected based on the type(s) and occurrence(s) of dose limiting toxicities which occur in addition to the MTD. If a MTD is not reached, then the RPTD will be defined based on the safety and pharmacokinetic data.
- Assess the effect of systemic ABBV-221 administration on QT prolongation [ Time Frame: At Days 1, 2, 3, 5, 8 of Cycle 1; Day 1 of every cycle starting at Cycle 2, and Final Visit (approximately 2 years from first dose of study drug) ]ECG parameters will be descriptively summarized, and the relationship between change of baseline of QT interval corrected for heart rate and concentration of three analytes will be explored.
- Objective Response Rate (ORR) [ Time Frame: At screening; at the end of Cycle 2 and the end of every 3 cycles for approximately 2 years from first dose of study drug ]ORR is the proportion of participants with objective response per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (complete or partial objective response) will be calculated for all dosed participants with at least one measurable lesion at baseline.
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|Ages Eligible for Study:||18 Years to 99 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2.
- Has a solid tumor likely to exhibit elevated levels of EGFR (e.g. head and neck squamous cell carcinoma, non-small cell lung cancer, triple negative breast cancer ,colorectal carcinoma and glioblastoma multiforme).
- Has an archived, diagnostic tumor tissue available for analysis.
- Has adequate hematologic, renal, cardiac and hepatic function.
- Expanded Safety Cohort participants must have confirmed metastatic lung cancer and progressed after receiving prior platinum-containing chemotherapy.
- Previously received an EGFR-directed monoclonal antibody within the past 4 weeks.
- Has unresolved, clinically significant toxicities from prior anti-cancer therapy defined as > Grade 1 on Common Terminology Criteria for Adverse Events.
- History of major immunologic reaction to any IgG containing agent.
- Any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02365662
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|United States, Texas|
|South Texas Accelerated Research Therapeutics|
|San Antonio, Texas, United States, 78229|
|Fundacion Jimenez Diaz|
|Madrid, Spain, 28040|
|Hosp Univ Madrid Sanchinarro|
|Madrid, Spain, 28050|
|Study Director:||AbbVie Inc.||AbbVie|
|Other Study ID Numbers:||
2014-003557-34 ( EudraCT Number )
|First Posted:||February 19, 2015 Key Record Dates|
|Last Update Posted:||March 30, 2018|
|Last Verified:||March 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Solid Tumor types likely to exhibit elevated levels of Epidermal Growth Factor Receptor
Triple Negative Breast Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Carcinoma, Squamous Cell
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Head and Neck Neoplasms
Digestive System Neoplasms
Digestive System Diseases