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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety (Number of subjects with adverse events and/or dose-limiting toxicities)

Outcome Description:

Evaluation of vital signs, clinical lab testing and adverse event monitoring (every other week), physical exam (every 4 weeks) and ECG (periodic)

Outcome Time Frame:

At each treatment visit (weekly for first 4 weeks and then at least every 4 weeks through end of treatment)

Safety Issue:

Yes

Principal Investigator

Kyle D. Holen, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

United States: Food and Drug Administration

Study ID:

M11-847

NCT ID:

NCT01255657

Start Date:

November 2010

Completion Date:

November 2012

Related Keywords:

  • Advanced Solid Tumors
  • Neoplasms

Name

Location

Site Reference ID/Investigator# 54056Baltimore, Maryland  21231
Site Reference ID/Investigator# 41931Boston, Massachusetts  02115
Site Reference ID/Investigator# 43422Tacoma, Washington  98405