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

Part of paid clinical trials in New York, New York.

Sponsor
Esanex Inc.
Study ID
NCT02973399
Phase
PHASE1
Status
Terminated

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 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 Dates

Start date
Feb 7, 2017
Status verified
Feb 2019
Primary completion
Dec 4, 2018
Completion
Feb 4, 2019

Study Design

Enrollment
5 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 for 2 cycles after a CR or 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: 6 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Weill Cornell Medical CollegeNew YorkNew York10065-
Wexner Medical Center, Ohio State UniversityColumbusOhio43210-

Find similar trials in New York, NY

By research site
Weill Cornell Medical College· New York, NYWexner Medical Center, Ohio State University· Columbus, OH

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