Study of SNX-5422 in TP53 Null Cancers
Condition: Cancer
Intervention: SNX-5422
Intervention description: Capsule(s) dosed every other day for 21 days (total 11 doses) out of a 28-day treatment cycle
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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 .
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.