Clinical trial NCT00292864: Safety Assessment of One-hour Infusions of SNS-032 for the Treatment of Select Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumors
Keywords: Cancer
Carcinoma
Adenocarcinoma
Tumor
Advanced solid tumors
Lead sponsor: Sunesis Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-02-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety
measure: Tolerability
Secondary outcomes:
measure: Pharmacokinetic profile
measure: Effect on QT interval
measure: Potential biomarkers
measure: Anti-tumor activity
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Premiere Oncology of Arizona
state: Arizona
city: Davis
country: United States
facility: University of California Davis Medical Center
state: California
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Sunesis Pharmaceuticals
name: Daniel C. Adelman, MD
role: STUDY_DIRECTOR
References:
citation: Malumbres M, Barbacid M. Cell cycle, CDKs and cancer: a changing paradigm. Nat Rev Cancer. 2009 Mar;9(3):153-66. doi: 10.1038/nrc2602.