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
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, see Learn About Clinical Studies.

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 September 22, 2014