A Study of ABT-414 in Subjects With Solid Tumors

Status: Recruiting
Diagnosis: Lung Cancer
NCT ID: NCT01741727 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-006


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


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital

Overall PI:
Leena Gandhi, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Rebecca Heist, MD, Massachusetts General Hospital

Dana-Farber Cancer Institute: Bryan Marion, bryan_marion@dfci.harvard.edu
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

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 </= 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. - 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 and have not received prior whole brain radiation (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.
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