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Study of Intravenously Administered SNS-032 in Patients With Advanced B-lymphoid Malignancies

Primary Purpose

B-lymphoid Malignancies, Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SNS-032 Injection
Sponsored by
Sunesis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-lymphoid Malignancies focused on measuring leukemia, lymphoma, myeloma, non-Hodgkin's, CLL, MCL, MM, Phase 1, hematological malignancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • City of Hope
  • Stanford Cancer Center
  • Winship Cancer Institute at Emory University
  • Greenebaum Cancer Center, University of Maryland
  • Hackensack University Medical Center at the Cancer Center
  • MD Anderson Cancer Center, University of Texas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose-escalation of SNS-032 injection

Arm Description

Patients escalated to MTD starting in Cohort 1 of 15 mg/m2 of SNS-032 injection, with 1.5-fold increase each cohort and a maximum loading dose increase of 10 mg/m2. Each dose cohort will have a minimum of 3 patients each with advanced CLL or MM. Dose escalation continues in the absence of Cycle 1 DLT criteria until an MTD is achieved for each disease type to a maximum of 7 cohorts at a high dose of 70 mg/m2. Stage 2 tests at MTD in larger group.

Outcomes

Primary Outcome Measures

To assess the safety and tolerability of SNS-032

Secondary Outcome Measures

To characterize the pharmacokinetic profile of SNS-032
Identify a recommended Phase 2 dose and schedule of administration

Full Information

First Posted
March 8, 2007
Last Updated
April 7, 2017
Sponsor
Sunesis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00446342
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunesis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose-escalation of SNS-032 injection
Arm Type
Experimental
Arm Description
Patients escalated to MTD starting in Cohort 1 of 15 mg/m2 of SNS-032 injection, with 1.5-fold increase each cohort and a maximum loading dose increase of 10 mg/m2. Each dose cohort will have a minimum of 3 patients each with advanced CLL or MM. Dose escalation continues in the absence of Cycle 1 DLT criteria until an MTD is achieved for each disease type to a maximum of 7 cohorts at a high dose of 70 mg/m2. Stage 2 tests at MTD in larger group.
Intervention Type
Drug
Intervention Name(s)
SNS-032 Injection
Intervention Description
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
Primary Outcome Measure Information:
Title
To assess the safety and tolerability of SNS-032
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To characterize the pharmacokinetic profile of SNS-032
Time Frame
1 year
Title
Identify a recommended Phase 2 dose and schedule of administration
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn Michelson, MD
Organizational Affiliation
Sunesis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Winship Cancer Institute at Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Greenebaum Cancer Center, University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Hackensack University Medical Center at the Cancer Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
MD Anderson Cancer Center, University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77230
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19238148
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.
Results Reference
derived

Learn more about this trial

Study of Intravenously Administered SNS-032 in Patients With Advanced B-lymphoid Malignancies

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