NCT00292864

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2006

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 7, 2012

Status Verified

June 1, 2012

First QC Date

February 15, 2006

Last Update Submit

June 5, 2012

Conditions

Tumors

Keywords

CancerCarcinomaAdenocarcinomaTumorAdvanced solid tumors

Outcome Measures

Primary Outcomes (2)

  • Safety

  • Tolerability

Secondary Outcomes (4)

  • Pharmacokinetic profile

  • Effect on QT interval

  • Potential biomarkers

  • Anti-tumor activity

Interventions

SNS-032 InjectionDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Premiere Oncology of Arizona

Scottsdale, Arizona, 85260, United States

Location

University of California Davis Medical Center

Davis, California, 95817, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (1)

  • 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.

    PMID: 19238148DERIVED

MeSH Terms

Conditions

NeoplasmsCarcinomaAdenocarcinoma

Interventions

N-(5-(((5-(1,1-dimethylethyl)-2-oxazolyl)methyl)thio)-2-thiazolyl)-4-piperidinecarboxamide

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Daniel C. Adelman, MD

    Sunesis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2006

First Posted

February 16, 2006

Study Start

January 1, 2006

Study Completion

December 1, 2007

Last Updated

June 7, 2012

Record last verified: 2012-06

Locations

US(6)