Safety and Pharmacology of SNX-5422 Plus Everolimus in Subjects With Neuroendocrine Tumors

Completed · Phase 1

Conditions studied: Cancer

In brief

Study is designed to determine the maximum tolerated dose (MTD) of SNX-5422 when given in combination with everolimus.

Key facts

Study ID

NCT02063958

Run by

Esanex Inc.

People needed

19

Starts

2014-02-01

Expected to finish

2018-03-20

Last updated by the study team

2018-07-30

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.
• Archived neuroendocrine tumor sample or biopsy sample (will also be used for genetic testing).
• Pathologic evidence of chemo-resistant Small Cell Lung cancer (relapse <90 days after 1st line), chemo-sensitive Small Cell Lung Cancer (relapse >90 days after first line), locally advanced metastatic neuroendocrine tumor of gastro-entero, pancreatic, pulmonary (other than Small Cell Lung) or thymic origin, or advanced renal cell carcinoma for which everolimus is indicated.
• Measurable (RECIST) indicator lesion not previously irradiated.
• Life expectancy of at least 3 months.
• No more than 4 prior lines of systemic anti-cancer therapy.
• 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 or aspartate aminotransferase ≤2 x ULN
• Hemoglobin ≥9 mg/dL.
• Creatinine <1.5 X upper limit of normal or estimated plasma creatinine clearance of ≥40 mL/min
• Signed informed consent form
• Recovered from toxicities of previous anticancer therapy
• Subjects with reproductive capability must agree to practice adequate contraception methods.

You may not qualify if…

• Subjects in whom everolimus is contraindicated.
• Subjects with clinically significant interstitial lung disease, or obstructive disease without sufficient reserve
• Carcinoid with hormone related symptoms
• Neuroendocrine cancer of the thyroid or thymus.
• Rare pancreatic neuroendocrine cancers such as, insulinomas, glucagonomas, gastrinomas.
• Prior treatment with any Hsp90 inhibitor.
• Prior failed treatment with mTOR inhibitors
• CNS metastases that are symptomatic and /or requiring escalating doses of steroids.
• Major surgery or significant traumatic injury within 4 weeks of starting study treatment.
• Conventional chemotherapy or radiation within 4 weeks.
• 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 appropriate 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.

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States
• Stanford Medicine — Stanford, California, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Center for Cancer Research, National Cancer Institute — Bethesda, Maryland, United States
• hackensack University Medical Center — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

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