Efficacy and Safety of SNX-5422 Added to an Established Dose of Ibrutinib in CLL

Stopped early · Phase 1

Conditions studied: Cancer

In brief

SNX-5422 is a prodrug of SNX-2112, a potent, highly selective, small molecule inhibitor of the molecular chaperone heat shock protein 90 (HSP90). Hsp90 inhibitors may overcome ibrutinib resistance in Mantle cell lymphomas and this study will investigate whether the addition of SNX-5422 to an established dose of ibrutinib will provide clinical response in subjects who have residual disease, but have not progressed on ibrutinib after 18 months of monotherapy, and/or prevents or delays disease progression of subjects with CLL.

Key facts

Study ID

NCT02973399

Run by

Esanex Inc.

People needed

5

Starts

2017-02-07

Expected to finish

2019-02-04

Last updated by the study team

2019-02-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or non-pregnant, non-breastfeeding females 18 years-of-age or older
• A diagnosis of CLL as defined by IWCLL 2008 criteria and currently on treatment with ibrutinib for at least 18 months with residual disease and without evidence of disease progression.
• No more than 4 prior lines of anti leukemia therapy (not including ibrutinib)
• Life expectancy of at least 9 months
• Karnofsky performance score 70
• Adequate baseline laboratory assessments
• Signed informed consent form
• Recovered from toxicities of previous anticancer therapy to CTCAE Grade ≤ 1
• Subjects with reproductive capability must agree to practice adequate contraception methods.

You may not qualify if…

• Subjects experiencing toxicity with ibrutinib
• Prior treatment with any Hsp90 inhibitor.
• Major surgery or significant traumatic injury within 4 weeks of starting study treatment.
• Conventional chemotherapy or radiation within 4 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
• Screening ECG QTc interval 470 msec for females, 450 msec for males.
• At increased risk for developing prolonged QT interval unless corrected to within normal limits prior to first dose of SNX-5422
• Patients with chronic diarrhea or with Grade 2 or greater diarrhea despite appropriate medical management.
• Gastrointestinal diseases or conditions that could affect drug absorption or could alter the assessment of safety
• History of documented adrenal dysfunction not due to malignancy.
• History of chronic liver disease.
• Active hepatitis A or B.
• Current alcohol dependence or drug abuse.
• Use of an investigational treatment (except for ibrutinib) from 30 days prior to the first dose
• Glaucoma, retinitis pigmentosa, macular degeneration, or any retinal changes detected by ophthalmological examination that are considered clinically important by examiner.
• Psychological or social reasons that would hinder or prevent compliance with the requirements of the protocol or compromise the informed consent process.

Where it is running

• Weill Cornell Medical College — New York, New York, United States
• Wexner Medical Center, Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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