Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Tumors

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Principal Investigator

Daniel C. Adelman, MD

Investigator Role:

Study Director

Investigator Affiliation:

Sunesis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

SPO-0007

NCT ID:

NCT00292864

Start Date:

January 2006

Completion Date:

December 2007

Related Keywords:

  • Tumors
  • Cancer
  • Carcinoma
  • Adenocarcinoma
  • Tumor
  • Advanced solid tumors

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
University of California Davis Medical CenterSacramento, California  95817
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Premiere Oncology of ArizonaScottsdale, Arizona  85260