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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02365662
Recruitment Status : Terminated (Safety)
First Posted : February 19, 2015
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief 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).

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Urogastrone

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Measured for approximately 4 years ]
    Adverse event monitoring will be performed during the study

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Spain
Fundacion Jimenez Diaz
Madrid, Spain, 28040
Hosp Univ Madrid Sanchinarro
Madrid, Spain, 28050
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02365662    
Other Study ID Numbers: M14-429
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

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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
Keywords provided by AbbVie:
Oncology
Cancer
Solid Tumor types likely to exhibit elevated levels of Epidermal Growth Factor Receptor
Solid Tumors
Additional relevant MeSH terms:
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Carcinoma
Glioblastoma
Triple Negative Breast Neoplasms
Squamous Cell Carcinoma of Head and Neck
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Carcinoma, Squamous Cell
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Breast Neoplasms
Breast Diseases
Skin Diseases
Head and Neck Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases