Safety and Efficacy of SNX-5422 in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Cancers

NCT01848756 | Terminated Phase 1 Results

• 1 other identifier: SNX-5422-CLN1-008
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

Brief Summary

Hsp90 is a chemical in the body that is involved in the promotion of cancer. SNX-5422 is an experimental drug that blocks Hsp90

Conditions

Cancer

Keywords

SNX-5422; HER2 positive cancer

Outcome Measures

Primary Outcomes (3)

• Objective Response Rate

  The effect of SNX-5422 on tumor progression. Objective tumor responses (complete remissions plus partial remissions) and clinical benefit rate (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).

  Up to 24 months from last patient entry

• Progression Free Survival

  Time on treatment with at worst stable disease.

  Every 3 months until 24 months after the last subject has been enrolled

• Overall Survival

  Time from start of treatment that patients remain alive.

  Every 3 months until 24 months after the last subject has been enrolled

Secondary Outcomes (4)

• Number of Patients With Adverse Events

  Day 28 of each cycle

• Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline

  Day 28 of each cycle

• Ophthalmologic Changes From Baseline

  Screening, end of Cycle 1, final visit

• Adverse Events by Severity and Relationship to Treatment

  Every 28 day cycle

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), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.

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:

• Males or non-pregnant, non-breastfeeding females .
• Confirmed diagnosis of locally advanced or metastatic breast, esophagogastric, urothelial, or non-small cell lung cancer.
• Histological or cytological confirmed carcinoma with HER2 amplification (IHC 3+ or FISH+ (\>2 HER2:CEP17)).
• Subjects with advanced or metastatic breast cancer must have received no more than 5 prior lines of anticancer therapy, including trastuzumab (but excluding hormonal treatments).
• Subjects with advanced or metastatic HER2 positive esophagogastric cancer must have received no more than 5 prior lines of anticancer therapy, including trastuzumab.
• Subjects with advanced or metastatic, urothelial carcinoma or non-small cell lung cancer must have received at least one, but no more than 5 prior lines of anticancer therapy.
• Measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
• Life expectancy of at least 3 months.
• Karnofsky performance score ≥70.
• Adequate baseline laboratory assessments
• Recovered from toxicities of previous anticancer therapy, with the exception of CTCAE grade 1 sensory neuropathy.

You may not qualify if:

• Subjects with symptomatic central nervous system (CNS) metastases who are neurologically unstable
• Prior treatment with any Hsp90 inhibitor.
• Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable disease.
• Major surgery within 4 weeks prior to first dose of SNX-5422.
• Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation).
• 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.
• Screening ECG QTc interval ≥470 msec for females, ≥450 msec for males.
• At increased risk for developing prolonged QT interval
• Patients with chronic diarrhea or with grade 2 or greater diarrhea 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.
• Known seropositive for human immunodeficiency virus (HIV) or hepatitis C virus (HCV).
• History of chronic liver disease.
• Active hepatitis A or B.

Sponsors & Collaborators

• Esanex Inc.: lead

Study Sites (4)

Scottsdale Healthcare

Scottsdale, Arizona, 85258, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

SNX-5422

Results Point of Contact

• Title: Eric Orlemans, Chief Scientific Officer
• Organization: Esanex Inc

eorlemans@esanexpharma.com

919-338-2019

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: May 7, 2013
• Study Start: April 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 9, 2017
• Results First Posted: November 21, 2016

Record last verified: 2016-12

Locations

US (4)