Safety and Pharmacology of SNX-5422 Plus Carboplatin and Paclitaxel in Subjects With Solid Tumors
Heat shock protein 90 (Hsp90) is a chemical in the body that is involve in the promotion of cancer. SNX-5422 is an experimental drug that blocks Hsp90.
Checked against the public recordLast updated Jul 26, 2017 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Esanex Inc.
- Interventions being studied
- Drug: SNX-5422
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Males or non-pregnant, non-breastfeeding females 18 years-of-age or older. * Pathologic evidence of Small Cell Lung Cancer, or Non-Small Cell Lung Cancer. * No more than one prior line of antitumor therapy for metastatic disease, excluding prior treatment with tyrosine kinase inhibitors. An interval of at least 1 week is required for washout of the tyrosine kinase inhibitor. * Measurable disease using RECIST criteria (version 1.1). * Life expectancy of at least 3 months. * 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) ≤2.0 x ULN except in subjects with known hepatic metastasis, where AST or ALT can be ≤5.0 x ULN. * Hemoglobin ≥9 mg/dL. * Estimated creatinine clearance of ≥40 mL/min * Recovered from toxicities of previous anticancer therapy to CTCAE Grade ≤ 1 with the exception of alopecia. * Signed informed consent form (ICF) * Subjects with reproductive capability must agree to practice adequate contraception methods. * Adequate venous access Exclusion Criteria: * CNS metastases that are symptomatic and /or requiring steroids. * Prior treatment with any Hsp90 inhibitor. * Major surgery or significant traumatic injury within 4 weeks of starting study treatment. * 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. * Treatment with other anticancer drugs within 28 days or 5 half-lives of anticancer therapy (whichever is shorter), and treatment with any other investigational agent is prohibited from 30 days prior to the first dose of SNX-5422 and throughout the study. * Radiation treatment within 2 weeks. * 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Georgetown University Medical CenterWashington D.C., District of Columbia
- Georgia Regents University Cancer CenterAugusta, Georgia
- Hackensack University Medical CenterHackensack, New Jersey
- Memorial Sloan Kettering Cancer CenterNew York, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 26, 2017. Always confirm current availability with the study team.