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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


Phase 1
18 Years
N/A
Not Enrolling
Both
B-lymphoid Malignancies, Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Multiple Myeloma

Thank you

Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To assess the safety and tolerability of SNS-032

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Glenn Michelson, MD

Investigator Role:

Study Director

Investigator Affiliation:

Sunesis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

SPO-0009

NCT ID:

NCT00446342

Start Date:

February 2007

Completion Date:

March 2009

Related Keywords:

  • B-lymphoid Malignancies
  • Chronic Lymphocytic Leukemia
  • Mantle Cell Lymphoma
  • Multiple Myeloma
  • leukemia
  • lymphoma
  • myeloma
  • non-Hodgkin's
  • CLL
  • MCL
  • MM
  • Phase 1
  • hematological malignancy
  • Neoplasms
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Lymphoma, Mantle-Cell

Name

Location

Stanford Cancer CenterStanford, California  94305-5824
City of HopeDuarte, California  91010
Winship Cancer Institute at Emory UniversityAtlanta, Georgia  30322
MD Anderson Cancer Center, University of TexasHouston, Texas  77030
Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Hackensack University Medical Center at the Cancer CenterHackensack, New Jersey  07601