Clinical trial NCT00446342: Study of Intravenously Administered SNS-032 in Patients With Advanced B-lymphoid Malignancies
Official title: Phase 1 Multicenter, Dose-Escalation Clinical Study of the Safety and Tolerability of Intravenously Administered SNS-032 Injection, a Novel Cyclin-Dependent Kinase Inhibitor, Administered to Patients With Advanced B-Lymphoid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: B-lymphoid Malignancies
Chronic Lymphocytic Leukemia
Mantle Cell Lymphoma
Multiple Myeloma
Keywords: leukemia
lymphoma
myeloma
non-Hodgkin's
CLL
MCL
MM
Phase 1
hematological malignancy
Lead sponsor: Sunesis Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-03-12
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: To assess the safety and tolerability of SNS-032
timeFrame: 1 year
Secondary outcomes:
measure: To characterize the pharmacokinetic profile of SNS-032
timeFrame: 1 year
measure: Identify a recommended Phase 2 dose and schedule of administration
timeFrame: 1 year
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Atlanta
country: United States
facility: Winship Cancer Institute at Emory University
state: Georgia
city: Baltimore
country: United States
facility: Greenebaum Cancer Center, University of Maryland
state: Maryland
city: Hackensack
country: United States
facility: Hackensack University Medical Center at the Cancer Center
state: New Jersey
city: Houston
country: United States
facility: MD Anderson Cancer Center, University of Texas
state: Texas
Study officials:
affiliation: Sunesis Pharmaceuticals
name: Glenn Michelson, 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.