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TerminatedNCT02612285Updated Nov 14, 2018Results posted

Study of SNX-5422 in TP53 Null Cancers

A Phase 2 interventional study of SNX-5422 in Cancer, sponsored by Esanex Inc.. Terminated at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-14.

Sponsored by Esanex Inc. · Phase 2, Interventional, and Treatment

Why this study was terminated
Recruitment very slow - study could not be enrolled
Phase
Phase 2
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 .

Read the detailed description

The tumor suppressor gene TP53 codes for a central regulator of the DNA-damage-response pathway, and its activation leads to cell-cycle arrest and DNA repair, apoptosis, or senescence through both transcription-dependent and transcriptional-independent activities. Somatic TP53 gene alterations are frequent in most human cancers.

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). Inhibitors of the chaperone protein Hsp90 are of current interest because of the central role that Hsp90 plays in the maturation and maintenance of numerous proteins that are critical for tumor cell viability and growth.

SNX-2112 retains activity in cell lines with loss of the TP53 gene from one of the alleles. SNX-2112 displays good activity in cell lines with TP53 null/TP53 wild type (e.g., MEC-1 [chronic lymphocytic leukemia]) and TP53 null/TP53 mutation (e.g., EBC-1, NCI-H520 [all NSCLC - squamous cell carcinoma]). Even in the most extreme case in which TP53 is lost from both alleles, i.e., the cancer cell is totally devoid of the TP53 gene (e.g., H1299, KATO III, HL-60, SK-MES-1), SNX-2112 retains activity

It appears that SNX-2112 could be active against both hematological and solid tumors with a TP53 null status.

02

Conditions studied

  • Cancer
03

In context

Lead sponsor

Esanex Inc. is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    SNX-5422

    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.

    Drug: SNX-5422

Interventions

  • DrugSNX-5422

    Capsule(s) dosed every other day for 21 days (total 11 doses) out of a 28-day treatment cycle

06

What researchers measure

Primary outcomes

  1. Clinical Response Rate

    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.

    Time frame: 6 months

07

Results

Posted Nov 14, 2018

Participant flow

Participant flow — Overall Study
MilestoneSNX-5422
Started1
Completed0
Not completed1
Withdrew: Withdrawal by subject1

Outcome measures

PrimaryClinical Response Rate

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.

Time frame:
6 months

No measurements were reported for this outcome.

Adverse events

Collected over Subject withdrew prior to receiving study drug. No data collected. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SNX-5422———

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)SNX-5422
<=18 years0
Between 18 and 65 years0
>=65 years1
Sex: Female, Male
Sex: Female, Male(Participants)SNX-5422
Female1
Male0
Region of Enrollment
Region of Enrollment(participants)SNX-5422
United States1
08

Study locations

5 sites
  • HonorHealth Research Institute
    Scottsdale, Arizona 85258, United States
  • Augusta University
    Augusta, Georgia 30912, United States
  • Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
  • Gabrail Cancer Center Research
    Canton, Ohio 44718, United States
  • Wexner Medical Center, Ohio State University
    Columbus, Ohio 43210, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02612285
Lead sponsor
Esanex Inc.
Responsible party
Sponsor
First posted
Nov 23, 2015
Start date
Mar 2016
Primary completion
Oct 2016
Completion
Oct 2016
Results posted
Nov 14, 2018
Last update
Nov 14, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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