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A Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of ABT-414 in Subjects With Advanced Solid Tumors Likely to Over-Express the Epidermal Growth Factor Receptor (EGFR)


Phase 2
18 Years
N/A
Open (Enrolling by invite only)
Both
Squamous Cell Tumors

Thank you

Trial Information

A Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of ABT-414 in Subjects With Advanced Solid Tumors Likely to Over-Express the Epidermal Growth Factor Receptor (EGFR)


Inclusion Criteria:



- 1) Subjects must have a solid tumor type likely to over-express Epidermal Growth
Factor Receptor (EGFR) (Phase 1)

- 2) Subjects have an Eastern Cooperative Oncology Group (ECOG) Performance Status of
0-2

- 3) Subjects have available tumor tissue

- 4) Subjects have adequate bone marrow, renal, and hepatic function as follows: Bone
marrow: Absolute neutrophil count (ANC) >/= 1,500/mm3 Platelets >/= 100,000/mm3;
Hemoglobin >/= 9.0 g/dL Renal function: Serum creatinine limit of the institution's normal range Hepatic function: Bilirubin, aspartate
aminotransferase (AST), and alanine aminotransferase (ALT) limit of the institution's normal range. Subjects with liver metastasis may have an
AST and ALT of
- 5) Subjects in the Phase 2 portion must have squamous cell Non-Small Cell Lung Cancer
(NSCLC)

Exclusion Criteria:

- 1) The subject has uncontrolled metastases to the central nervous system (CNS).
Subjects with brain metastases are eligible provided they have shown clinical and
radiographic stable disease for at least 28 days after definitive therapy (Phase 1
only).

- 2) The subject has received anticancer therapy including chemotherapy, immunotherapy,
radiotherapy, hormonal, biologic, or any investigational therapy within a period of
28 days prior to the first dose of ABT-414.

- 3) The subject has unresolved clinically significant toxicities from prior anticancer
therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade
2 or higher.

- 4) The subject had had major surgery within 28 days prior to the first dose of
ABT-414.

- 5) The subject has a history of immunologic reaction to any Immunoglobulin G (IgG)
containing agent.

- 6) Phase 2 portion only: The subject has previous or concurrent cancer that is
distinct in primary site or histology from NSCLC, except cervical carcinoma in situ,
non-melanoma carcinoma of the skin or in situ carcinoma of the bladder. Any cancer
curatively treated greater than 3 years prior to entry is permitted.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase 1 - 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, physical exam and electrocardiogram (ECG) (periodic)

Outcome Time Frame:

Every 1-3 weeks for an average of 20 weeks

Safety Issue:

Yes

Principal Investigator

Kyle Holen, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

Canada: Health Canada

Study ID:

M13-379

NCT ID:

NCT01741727

Start Date:

October 2012

Completion Date:

February 2015

Related Keywords:

  • Squamous Cell Tumors
  • Neoplasms, Squamous Cell

Name

Location

Site Reference ID/Investigator# 83155San Antonio, Texas  78229