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SNS-032

Phase 1

B-lymphoid Malignancies | Small molecule | Oncology |Viracta Therapeutics, Inc.|Last Updated: Apr 11, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

SNS-032 · 2 trials · 5 indications

Phase 1 2
NCT00446342Study of Intravenously Administered SNS-032 in Patients With Advanced B-lymphoid MalignanciesB-lymphoid Malignancies
COMPLETED21 Analytics
NCT00292864Safety Assessment of One-hour Infusions of SNS-032 for the Treatment of Select Advanced Solid TumorsTumors
COMPLETED25 Analytics
PHASE1COMPLETED
Study of Intravenously Administered SNS-032 in Patients With Advanced B-lymphoid Malignancies
B-lymphoid MalignanciesUnlock trial analytics
PHASE1COMPLETED
Safety Assessment of One-hour Infusions of SNS-032 for the Treatment of Select Advanced Solid Tumors
TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the safety and tolerability of SNS-032
1 year
Safety
Tolerability

Secondary Endpoints

To characterize the pharmacokinetic profile of SNS-032
1 year
Identify a recommended Phase 2 dose and schedule of administration
1 year
Pharmacokinetic profile
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose-escalation of SNS-032 injectionEXPERIMENTALPatients escalated to MTD starting in Cohort 1 of 15 mg/m2 of SNS-032 injection, with 1.5-fold increase each cohort and a maximum loading dose increase of 10 mg/m2. Each dose cohort will have a minimum of 3 patients each with advanced CLL or MM. Dose escalation continues in the absence of Cycle 1 DLT criteria until an MTD is achieved for each disease type to a maximum of 7 cohorts at a high dose of 70 mg/m2. Stage 2 tests at MTD in larger group.

Interventions

NameTypeDescription
SNS-032 InjectionDRUGStage 1: Escalating doses of SNS-032 on days 1, 8 and 15 per 28 day cycle Stage 2: Same as stage 1 except SNS-032 administered at the maximum tolerated dose established in stage 1
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Cytologically or histologically confirmed chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), or multiple myeloma (MM). * Evidence of relapsed disease * Measurable disease * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 Exclusion Cri...

Countries:United States
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Frequently asked questions about SNS-032

What is SNS-032 used for?

SNS-032 is an investigational small molecule being studied for the treatment of B-lymphoid malignancies and tumors. It has been evaluated in Phase 1 clinical trials for advanced solid tumors and advanced B-lymphoid malignancies, including chronic lymphocytic leukemia, mantle cell lymphoma, and multiple myeloma.

Who makes SNS-032?

SNS-032 is being developed by Viracta Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol VIRX. The company has conducted clinical trials of SNS-032 in the United States.

What phase is SNS-032 in?

SNS-032 is in Phase 1 clinical development. It is an investigational drug that has completed two Phase 1 trials, one in advanced solid tumors and one in advanced B-lymphoid malignancies. It is not FDA approved and remains in clinical development.

What clinical trials is SNS-032 in?

SNS-032 has been studied in two completed Phase 1 clinical trials: NCT00292864, which assessed one-hour infusions of SNS-032 in 25 patients with advanced solid tumors, and NCT00446342, which studied intravenously administered SNS-032 in 21 patients with advanced B-lymphoid malignancies.

What is the mechanism of action of SNS-032?

SNS-032 is a small molecule that targets cyclin-dependent kinases, which are enzymes involved in cell cycle regulation. By inhibiting these kinases, SNS-032 is designed to interfere with cancer cell proliferation. This mechanism is being investigated for its potential in treating certain cancers.