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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01255657
First received: November 22, 2010
Last updated: January 4, 2013
Last verified: January 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

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) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Assay for Anti-drug antibody against ABT-806

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

  • Infusion rate evaluation (Expanded Safety Cohort) [ Time Frame: Every other week ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.
Other Name: ABT-806

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01255657     History of Changes
Other Study ID Numbers: M11-847
Study First Received: November 22, 2010
Last Updated: January 4, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 23, 2014