Study of SNX-5422 in TP53 Null Cancers

Stopped early · Phase 2

Conditions studied: Cancer

In brief

SNX-5422 is a pro-drug of SNX-2112, a potent, highly selective, small-molecule inhibitor of the molecular chaperone heat shock protein 90 (Hsp90). Initial in vitro evidence supports that SNX-5422 may be active against TP53 null tumors irrespective of tumor type .

Key facts

Study ID

NCT02612285

Run by

Esanex Inc.

People needed

1

Starts

2016-03-01

Expected to finish

2016-10-01

Last updated by the study team

2018-11-14

Who can join

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

You may qualify if…

• Confirmed solid or hematological TP53 null type cancer.
• No more than 4 prior lines of systemic anti-cancer therapy.
• Males or non-pregnant, non-breastfeeding females 18 years-of-age or older.
• Karnofsky performance score 60
• Life expectancy of at least 3 months.
• Adequate baseline laboratory assessments
• Recovered from toxicities of previous anticancer therapy to CTCAE Grade ≤ 1 with the exception of alopecia.

You may not qualify if…

• Treatment with an investigational agent within 30 days prior to the first dose of SNX-5422 or planning to receive an investigational agent during the study.
• Treatment with other anticancer drugs within 28 days or 5 half-lives of anticancer therapy (whichever is shorter) is prohibited from 30 days prior to the first dose of SNX-5422 and throughout the study.
• Radiation treatment 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 (Appendix B).
• Appropriately corrected screening ECG QTc interval 470 msec for females, 450 msec for males.
• Currently receiving medications known to cause QT prolongation AND corrected QTc of 450 msec for females, 430 msec for males.
• Patients with chronic diarrhea of grade 2 or greater 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.
• 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.
• Clinically significant glaucoma, retinitis pigmentosa, or macular degeneration.
• Other serious concurrent illness or medical condition.

Where it is running

• HonorHealth Research Institute — Scottsdale, Arizona, United States
• Augusta University — Augusta, Georgia, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Gabrail Cancer Center Research — Canton, Ohio, United States
• Wexner Medical Center, Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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