Clinical trial · Interventional
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
NCT00292864CI-TRIAL-00007123completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SNS-032 Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Safety
- measure
- Tolerability
Secondary outcomes (4)
- measure
- Pharmacokinetic profile
- measure
- Effect on QT interval
- measure
- Potential biomarkers
- measure
- Anti-tumor activity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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/exclusion criteria for this study. Please contact the study center for additional information and to determine if all study criteria are met.
References
Publications (1)
- DERIVEDMalumbres M, Barbacid M. Cell cycle, CDKs and cancer: a changing paradigm. Nat Rev Cancer. 2009 Mar;9(3):153-66. doi: 10.1038/nrc2602. PMID 19238148