Clinical trial · Interventional
Study of SNX-5422 in TP53 Null Cancers
A Single Arm Study of SNX-5422 in Subjects With TP53 Null Cancers
NCT02612285CI-TRIAL-00035753terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment very slow - study could not be enrolled
Summary
Brief summary (as posted)
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 .
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SNX-5422 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SNX-5422
- description
- Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), followed by a 7-day drug-free period. Each treatment cycle will be 28 days. Subjects will repeat this 28-day schedule until the cancer progresses or the subject is unable to tolerate SNX-5422.
- interventionNames
- Drug: SNX-5422
Primary outcomes (1)
- measure
- Clinical Response Rate
- timeFrame
- 6 months
- description
- Effect of SNX-5422 on tumor progression. Complete remissions plus partial remissions plus stable disease at ≥6 months) will be listed by subject. Tumor measurements made using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or appropriate hematological malignancy criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.