A Study of ABT-414 in Subjects With Solid Tumors

Completed · Phase 1

Conditions studied: Squamous Cell Tumors

In brief

A study of ABT-414 in subjects with solid tumors.

Key facts

Study ID

NCT01741727

Run by

AbbVie (prior sponsor, Abbott)

People needed

57

Starts

2012-10-01

Expected to finish

2015-11-01

Last updated by the study team

2017-11-20

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must have a solid tumor type likely to over-express Epidermal Growth Factor Receptor (EGFR) (Phase 1)
• Subjects have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
• Subjects have available tumor tissue
• 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 </= 1.5 times the upper limit of the institution's normal range Hepatic function: Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) </= 1.5 times the upper limit of the institution's normal range. Subjects with liver metastasis may have an AST and ALT of </= 5.0 x the upper limit of normal.
• Subjects in the Phase 2 portion must have squamous cell Non-Small Cell Lung Cancer (NSCLC)
• Eligibility is restricted to subjects with confirmed EGFR amplification in the EGFR amplified cohort

You may not qualify if…

• 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 and have not received prior whole brain radiation (Phase 1 only).
• 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.
• 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.
• The subject had had major surgery within 28 days prior to the first dose of ABT-414.
• The subject has a history of immunologic reaction to any Immunoglobulin G (IgG) containing agent.
• 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.

Where it is running

• Site Reference ID/Investigator# 90333 — Scottsdale, Arizona, United States
• Site Reference ID/Investigator# 83156 — Chicago, Illinois, United States
• Site Reference ID/Investigator# 117516 — Boston, Massachusetts, United States
• Site Reference ID/Investigator# 83154 — Boston, Massachusetts, United States
• Site Reference ID/Investigator# 83155 — San Antonio, Texas, United States
• Site Reference ID/Investigator# 89035 — Ottawa, Canada

Full record on ClinicalTrials.gov

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