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A Study of ABT-806 in Subjects With Advanced Solid Tumor Types

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01255657
First Posted: December 7, 2010
Last Update Posted: January 7, 2013
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.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
  Purpose
This is an open-label study designed to determine the recommended Phase 2 dose (RPTD) and evaluate the safety and pharmacokinetics of ABT-806 in subjects with advanced solid tumors.

Condition Intervention Phase
Advanced Solid Tumors Drug: ABT-806 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of ABT-806 in Subjects With Advanced Solid Tumor Types Likely to Either Overexpress Wild-Type Epidermal Growth Factor Receptor (EGFR) or to Express Variant III Mutant EGFR

Further study details as provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Primary Outcome Measures:
  • Safety (Number of subjects with adverse events and/or dose-limiting toxicities) [ Time Frame: At each treatment visit (weekly for first 4 weeks and then at least every 4 weeks through end of treatment) ]
    Evaluation of vital signs, clinical lab testing and adverse event monitoring (every other week), physical exam (every 4 weeks) and ECG (periodic)

  • Pharmacokinetic profile (assay for ABT-806) Dose Escalation Cohort [ Time Frame: Week 1, 2, 3, 5, 7, 8, 9, 11, 13, 15, 19, 23 and Final Visit ]
    Assay for ABT-806

  • Pharmacokinetic profile (assay for ABT-806) Expanded Safety Cohort [ Time Frame: Week 1, 3, 5, 7, 11, 13, 15, 19, 23 and 30 Day Follow-up ]
    Assay for ABT-806


Secondary Outcome Measures:
  • Pharmacokinetic profile (assay for Anti-drug Antibody) Dose Escalation Cohort [ Time Frame: Week 1, 3, 7, 11, 15, 19, 23 and Final Visit ]
    Assay for Anti-drug antibody against ABT-806

  • QT assessment [ Time Frame: Week 1, 7, 13, and 30 day follow-up visit ]
    Triplicate ECGs

  • Infusion rate evaluation (Expanded Safety Cohort) [ Time Frame: Every other week ]
    Two infusion times explored

  • Pharmacokinetic profile (assay for Anti-drug Antibody) Expanded Safety Cohort [ Time Frame: Week 1, 3, 7, 11, 15, 19, 23 and 30 Day Follow-up ]
    Assay for Anti-drug antibody against ABT-806


Enrollment: 49
Study Start Date: November 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-806 Arm Drug: ABT-806
ABT-806 will be administered by intravenous infusion.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has a solid tumor of a type known to either over-express wild-type EGFR or to express variant III mutant EGFR (e.g., head and neck squamous cell carcinoma, non small cell lung cancer (NSCLC), colorectal carcinoma) or a tumor known to be EGFR positive.
  • Subject must have disease that is not amenable to surgical resection or other approved therapeutic options with curative intent.
  • Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
  • Subject must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
  • Inclusion criteria for Expand Safety Cohort B - subject has histologically confirmed supratentorial glioblastoma multiforme (GBM) .

Exclusion Criteria:

  • Subject has uncontrolled metastases to the central nervous system. Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 1 month after definitive therapy. Subjects with glioblastoma multiforme (GBM) are excluded from the dose escalation portion of the study, but may be enrolled in the expanded safety cohort.
  • Subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 21 days prior to the first dose of ABT-806.
  • Subject has had any adjustments of an ongoing steroid medication during the 14 days prior to the first dose of ABT-806.
  • Subject has received a prior EGFR-directed monoclonal antibody within a period of 4 weeks prior to the first dose of ABT-806.
  • Subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
  Contacts and Locations
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): NCT01255657


Locations
United States, Maryland
Site Reference ID/Investigator# 54056
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Site Reference ID/Investigator# 41931
Boston, Massachusetts, United States, 02215
United States, Washington
Site Reference ID/Investigator# 43422
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Kyle D. Holen, MD AbbVie
  More Information

Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01255657     History of Changes
Other Study ID Numbers: M11-847
First Submitted: November 22, 2010
First Posted: December 7, 2010
Last Update Posted: January 7, 2013
Last Verified: January 2013