Safety and Pharmacology Study of SNX-5422 in Subjects With Refractory Hematological Malignancies

Completed · Phase 1

Conditions studied: Cancer

In brief

Hsp90 is a chemical in the body that is involved int he promotion of cancer. SNX-5422 is an experimental drug that blocks Hsp90.

Key facts

Study ID

NCT01635712

Run by

Esanex Inc.

People needed

10

Starts

2014-02-01

Expected to finish

2017-02-01

Last updated by the study team

2017-04-26

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 with histologically confirmed non-Hodgkins lymphoma, without known or clinically suspected CNS involvement, that is refractory to available therapy or for which there is no available therapy.
• No more than 4 prior lines of systemic anti-cancer therapy and no prior bone marrow transplant or stem cell transplant within 12 months of dosing, and no prior allogeneic transplant.
• Karnofsky performance score ≥60
• Life expectancy of at least 3 months.
• Adequate baseline laboratory assessments

You may not qualify if…

• Currently receiving anticancer therapy or have received anticancer therapy within the past 28 days or 5 half-lives of the anticancer therapy
• 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
• At increased risk for developing prolonged QT interval, including hypokalemia or hypomagnesemia, unless corrected to within normal limits prior to first dose of SNX-• Chronic diarrhea.
• 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.
• Seropositive for human immunodeficiency virus (HIV) or hepatitis C virus (HCV).
• History of chronic liver disease

Where it is running

• UC Davis Comprehensive Cancer Center — Sacramento, California, United States
• Georgia Regents University Cancer Center — Augusta, Georgia, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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