Safety Assessment of One-hour Infusions of SNS-032 for the Treatment of Select Advanced Solid Tumors

Phase 1 Open-Label, Multicenter, Dose-Escalation Clinical Study of the Safety and Tolerability of SNS-032, a Novel Cyclin-Dependent Kinase Inhibitor, Administered to Patients With Select Advanced Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00292864

Enrollment

Registered

2006-02-16

Start date

2006-01-31

Completion date

2007-12-31

Last updated

2012-06-07

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

Conditions

Tumors

Keywords

Cancer, Carcinoma, Adenocarcinoma, Tumor, Advanced solid tumors

Brief summary

The purpose of this study is to assess the safety and tolerability of one-hour infusions given once daily for 5 consecutive days in a 21-day treatment cycle; to define a recommended phase 2 dose; and to learn more about the clinical activity of SNS-032.

Detailed description

Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the body), preliminary evaluation of biomarkers to see how the levels of certain proteins change after administration of SNS-032; assessment of the effects of SNS-032 on QT interval.

Interventions

DRUGSNS-032 Injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Able to provide written informed consent * Advanced, progressing solid tumor that has no cure * In Stage 1, any advanced solid malignancy * In Stage 2, advanced breast cancer, melanoma, or non-small cell lung cancer (NSCLC) * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2 * Recovered from radiation therapy that may have been given in the last 21 days * Recovered from surgery

Exclusion criteria

* Prior exposure to SNS-032 (previously known as BMS-387032) * Pregnant or breastfeeding * Women or male partners of women who are able to have children but are unwilling to use an approved, effective means of birth control * Took part in another clinical trial during the last 21 days * Abnormal lab values for serum potassium, hemoglobin, neutrophils, platelets, creatinine, AST, ALT, or total bilirubin * Brain metastases, if patient is not neurologically stable or has needed corticosteroids or anticonvulsants at anytime within the 28 day period before enrollment. * Other active malignancies * Prior pelvic radiation therapy to ≥ 25% of bone marrow reserve * Any other condition that would keep the patient from safely taking part in the clinical trial Please note: There are additional inclusion/

Design outcomes

Primary

Measure	Time frame
Safety	—
Tolerability	—

Secondary

Measure	Time frame
Pharmacokinetic profile	—
Effect on QT interval	—
Potential biomarkers	—
Anti-tumor activity	—

Countries

United States

Outcome results

None listed

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