Safety and Pharmacology Study of SNX-5422 in Subjects With Resistant Lung Adenocarcinoma

Completed · Phase 1

Conditions studied: Cancer

In brief

Heat shock protein 90 (Hsp90) is a chemical in the body that is involved in the promotion of cancer. SNX-5422 is an experimental drug that blocks Hsp90.

Key facts

Study ID

NCT01851096

Run by

Esanex Inc.

People needed

17

Starts

2013-03-01

Expected to finish

2016-08-01

Last updated by the study team

2016-08-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or non-pregnant, non-breastfeeding females 18 years-of-age or older.
• Received treatment with erlotinib/gefitinib throughout the one month prior to enrollment and at least six months at any time.
• Must have undergone a biopsy after the development of acquired resistance.
• Pathologic evidence of advanced lung adenocarcinoma (stage IIIB or stage IV) confirmed histologically/cytologically
• Radiographic progression by RECIST during treatment with erlotinib/gefitinib.
• Measurable (RECIST) indicator lesion not previously irradiated.
• No more than 4 prior lines of cytotoxic chemotherapy, including erlotinib/gefitinib
• Karnofsky performance score ≥70.
• Adequate baseline laboratory assessments, including
• Absolute neutrophil count (ANC) ≥1.5 x 109/L.
• WBC >3000/microliter
• Platelet count of ≥100 x 109/L.
• Total bilirubin level ≤1.5 times institutional upper limit of normal (ULN), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤1.5 x ULN.
• Hemoglobin ≥9 mg/dL.
• Creatinine <1.5 X upper limit of normal or estimated plasma creatinine clearance of ≥40 mL/min (using the Cockroft-Gault equation)
• Signed informed consent form (ICF).
• Subjects with reproductive capability must agree to practice adequate contraception methods.
• Adequate venous access.

You may not qualify if…

• CNS metastases which are symptomatic and /or requiring escalating doses of steroids.
• Prior treatment with any Hsp90 inhibitor.
• Conventional chemotherapy, radiation or monoclonal antibodies within 4 weeks (erlotinib/gefitinib therapy within the past 4 weeks IS allowed).
• Palliative radiation within 2 weeks.
• The need for treatment with medications with clinically-relevant metabolism by the cytochrome P450 (CYP) 3A4 isoenzyme within 3 hours before or after administration of SNX-5422
• Screening ECG QTc interval ≥470 msec for females, ≥450 msec for males.
• At increased risk for developing prolonged QT interval, including hypokalemia or hypomagnesemia, unless corrected to within normal limits prior to first dose of SNX-5422; congenital long QT syndrome or a history of torsade de pointes; currently receiving anti-arrhythmics or other medications that may be associated with QT prolongation.
• Patients with chronic diarrhea or with grade 2 or greater diarrhea despite maximal medical management.
• Gastrointestinal diseases or conditions that could affect drug absorption, including gastric bypass.
• Gastrointestinal diseases that could alter the assessment of safety, including irritable bowel syndrome, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis.
• History of documented adrenal dysfunction not due to malignancy.
• Known seropositive for human immunodeficiency virus (HIV) or hepatitis C virus (HCV).
• History of chronic liver disease.
• Active hepatitis A or B.
• Current alcohol dependence or drug abuse.
• Use of an investigational treatment from 30 days prior to the first dose of SNX-5422 and during the study.
• Glaucoma, retinitis pigmentosa, macular degeneration, or any retinal changes detected by ophthalmological examination.
• Other serious concurrent illness or medical condition.
• Psychological, social, familial, or geographical reasons that would hinder or prevent compliance with the requirements of the protocol or compromise the informed consent process.

Where it is running

• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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