Study of SNX-5422 in TP53 Null Cancers

NCT02612285 | Terminated Phase 2 Results

• 1 other identifier: SNX-5422-CLN2-010
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 5

Brief 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 .

Conditions

Cancer

Outcome Measures

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.

  6 months

Study Arms (1)

SNX-5422

EXPERIMENTAL

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

SNX-5422 DRUG

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

SNX-5422

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Esanex Inc.: lead

Study Sites (5)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

Wexner Medical Center, Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

SNX-5422

Results Point of Contact

• Title: Eric Orlemans PhD
• Organization: Esanex Inc

eorlemans@esanexpharma.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: November 23, 2015
• Study Start: March 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 14, 2018
• Results First Posted: November 14, 2018

Record last verified: 2018-10

Locations

US (5)