Safety and Activity of SNX-5422 Plus Ibrutinib in CLL

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Esanex Inc.
Study ID
NCT02914327
Phase
PHASE1
Status
Withdrawn

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SNX-5422 plus ibrutinib — DRUG
    SNX-5422 capsule(s) dosed every other day for 21 days out of a 28-day treatment cycle to a total dose of 56 mg/m2 SNX-5422. Subjects will self-administer daily oral ibrutinib in the afternoon at least 8 hours apart from SNX-5422 for 28 days of each cycle.

Study Details

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 result in the removal of mutated BTK from blood mononuclear cells and/or prevents or delays disease progression of subjects with CLL

Key Dates

Start date
Feb 2, 2017
Status verified
Jul 2018
Primary completion
Jul 1, 2018
Completion
Jul 1, 2018

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SNX-5422 plus ibrutinib
    Open-label administration of SNX-5422 capsules dosed in the morning once every other day for 21 days (11 doses) followed by a 7 day drug free period and daily with the established ibrutinib dose for 28 days of a 28-days cycle. Subjects will repeat the 28-day schedule until the cancer progresses or the subject is unable to tolerate the therapy

Primary Outcome Measure

Efficacy of the combination of SNX-5422 and ibrutinib [ Time Frame: Every 12 weeks up to 52 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wexner Medical Center, Ohio State UniversityColumbusOhio43210-

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By research site
Wexner Medical Center, Ohio State University· Columbus, OH

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