Study of Intravenously Administered SNS-032 in Patients With Advanced B-lymphoid Malignancies

Phase 1 Multicenter, Dose-Escalation Clinical Study of the Safety and Tolerability of Intravenously Administered SNS-032 Injection, a Novel Cyclin-Dependent Kinase Inhibitor, Administered to Patients With Advanced B-Lymphoid Malignancies

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00446342

Enrollment

Registered

2007-03-12

Start date

2007-02-28

Completion date

2009-03-31

Last updated

2017-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-lymphoid Malignancies, Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Multiple Myeloma

Keywords

leukemia, lymphoma, myeloma, non-Hodgkin's, CLL, MCL, MM, Phase 1, hematological malignancy

Brief summary

The purpose of this study is to assess the safety and tolerability of escalating doses of SNS-032, given in 3 weekly administrations per cycle and to identify a recommended Phase 2 dose.

Detailed description

Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the body) and identifying potential biomarkers.

Interventions

DRUGSNS-032 Injection

Stage 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 criteria

* Prior treatment with SNS-032 injection (previously known as BMS-387032) * Pregnant or breastfeeding * Unwilling to use an approved, effective means of contraception according to the study site's standards * Use of therapeutic anticoagulation agents * Prior allogeneic bone marrow transplantation * Prior chemotherapy, monoclonal antibodies, investigational agents, or radiation therapy within 21 days before the first dose; nitrosoureas and mitomycin are not permitted for at least 42 days before the first dose. * Prior pelvic radiation therapy or radiation to \> 25% of bone marrow reserve * Any other medical, psychological, or social condition that would contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures Please note: There are additional inclusion/

Design outcomes

Primary

Measure	Time frame
To assess the safety and tolerability of SNS-032	1 year

Secondary

Measure	Time frame
To characterize the pharmacokinetic profile of SNS-032	1 year
Identify a recommended Phase 2 dose and schedule of administration	1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026