Status:
TERMINATED
Safety and Efficacy of SNX-5422 in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Cancers
Lead Sponsor:
Esanex Inc.
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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
Detailed Description
Heat shock protein 90 (Hsp90) chaperone proteins stabilize well over 200 different known client proteins helping them to fold correctly as they take up their rightful positions in the cell. Hsp90 has ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Current alcohol dependence or drug abuse.
- Treatment with other anticancer drugs within 28 days or 5 half-lives of anticancer therapy (whichever is shorter), and treatment with any other investigational agent is prohibited from 30 days prior to the first dose of SNX-5422 and throughout the study
- Glaucoma, retinitis pigmentosa, macular degeneration, or any retinal changes detected by ophthalmological examination.
- Other serious concurrent illness or medical condition.
- Psychological, social, familial, or geographical reasons that would hinder or prevent compliance with the requirements of the protocol or compromise the informed consent process.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01848756
Start Date
April 1 2013
End Date
June 1 2015
Last Update
February 9 2017
Active Locations (4)
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1
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
2
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
3
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
4
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065