NCT00446342

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2007

Typical duration for phase_1

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

February 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 8, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

1.8 years

First QC Date

March 8, 2007

Last Update Submit

April 7, 2017

Conditions

B-lymphoid MalignanciesChronic Lymphocytic LeukemiaMantle Cell LymphomaMultiple Myeloma

Keywords

leukemialymphomamyelomanon-Hodgkin'sCLLMCLMMPhase 1hematological malignancy

Outcome Measures

Primary Outcomes (1)

  • To assess the safety and tolerability of SNS-032

    1 year

Secondary Outcomes (2)

  • To characterize the pharmacokinetic profile of SNS-032

    1 year

  • Identify a recommended Phase 2 dose and schedule of administration

    1 year

Study Arms (1)

Dose-escalation of SNS-032 injection

EXPERIMENTAL

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.

Drug: SNS-032 Injection

Interventions

SNS-032 InjectionDRUG

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

Dose-escalation of SNS-032 injection

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

City of Hope

Duarte, California, 91010, United States

Location

Stanford Cancer Center

Stanford, California, 94305, United States

Location

Winship Cancer Institute at Emory University

Atlanta, Georgia, 30322, United States

Location

Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

Hackensack University Medical Center at the Cancer Center

Hackensack, New Jersey, 07601, United States

Location

MD Anderson Cancer Center, University of Texas

Houston, Texas, 77230, 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

Leukemia, Lymphocytic, Chronic, B-CellLymphoma, Mantle-CellMultiple MyelomaLeukemiaLymphomaNeoplasms, Plasma CellHematologic Neoplasms

Interventions

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

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, Non-HodgkinHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersNeoplasms by Site

Study Officials

  • Glenn Michelson, MD

    Sunesis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2007

First Posted

March 12, 2007

Study Start

February 1, 2007

Primary Completion

December 1, 2008

Study Completion

March 1, 2009

Last Updated

April 11, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(6)