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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00446342
Other study ID # SPO-0009
Secondary ID
Status Completed
Phase Phase 1
First received March 8, 2007
Last updated April 7, 2017
Start date February 2007
Est. completion date March 2009

Study information

Verified date April 2017
Source Sunesis Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and tolerability of escalating doses of SNS-032, given in 3 weekly administrations per cycle and to identify a recommended Phase 2 dose.


Description:

Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the body) and identifying potential biomarkers.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date March 2009
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Cytologically or histologically confirmed chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), or multiple myeloma (MM).

- Evidence of relapsed disease

- Measurable disease

- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

Exclusion Criteria:

- Prior treatment with SNS-032 injection (previously known as BMS-387032)

- Pregnant or breastfeeding

- Unwilling to use an approved, effective means of contraception according to the study site's standards

- Use of therapeutic anticoagulation agents

- Prior allogeneic bone marrow transplantation

- Prior chemotherapy, monoclonal antibodies, investigational agents, or radiation therapy within 21 days before the first dose; nitrosoureas and mitomycin are not permitted for at least 42 days before the first dose.

- Prior pelvic radiation therapy or radiation to > 25% of bone marrow reserve

- Any other medical, psychological, or social condition that would contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures

Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if the patient meets all study criteria.

Study Design


Intervention

Drug:
SNS-032 Injection
Stage 1: Escalating doses of SNS-032 on days 1, 8 and 15 per 28 day cycle Stage 2: Same as stage 1 except SNS-032 administered at the maximum tolerated dose established in stage 1

Locations

Country Name City State
United States Winship Cancer Institute at Emory University Atlanta Georgia
United States Greenebaum Cancer Center, University of Maryland Baltimore Maryland
United States City of Hope Duarte California
United States Hackensack University Medical Center at the Cancer Center Hackensack New Jersey
United States MD Anderson Cancer Center, University of Texas Houston Texas
United States Stanford Cancer Center Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Sunesis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess the safety and tolerability of SNS-032 1 year
Secondary To characterize the pharmacokinetic profile of SNS-032 1 year
Secondary Identify a recommended Phase 2 dose and schedule of administration 1 year
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