NCT00298896

Brief Summary

The purpose of this study is to evaluate the objective tumor response rate to SNS-595 in patients with small cell lung cancer (SCLC).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2006

Geographic Reach
2 countries

17 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, 2006

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
10.2 years until next milestone

Results Posted

Study results publicly available

July 26, 2018

Completed
Last Updated

July 26, 2018

Status Verified

October 1, 2017

Enrollment Period

1.5 years

First QC Date

March 1, 2006

Results QC Date

April 12, 2017

Last Update Submit

October 19, 2017

Conditions

Carcinoma, Small CellSmall Cell Lung Cancer

Keywords

LungSquamous CellSmall CellCarcinomaCancerSmall Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate

    Objective tumor response rate based on the RECIST criteria for target lesions as assessed by CT or MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD), at least a 20% increase in the sum of the LD of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Overall Response (OR) = CR + PR

    up to 6 months

Secondary Outcomes (1)

  • Best Overall Response

    upto 6 months

Study Arms (1)

SNS-595

EXPERIMENTAL

SNS-595; 48 mg/m2 administered IV once every 21 days for up to 6 cycles.

Drug: SNS-595

Interventions

SNS-595DRUG
Also known as: Voreloxin, Vosaroxin
SNS-595

Eligibility Criteria

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

You may qualify if:

  • Able to understand and willing to sign a written informed consent document
  • Patients who have recurrent or refractory SCLC requiring second-line chemotherapy who previously received first-line chemotherapy
  • Measurable disease
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
  • Brain metastasis may be included if the patient is neurologically stable and has been off steroids and anticonvulsants for at least 4 weeks prior to Cycle 1 Day 0
  • Laboratory values within the normal or reasonable reference range as specified by the protocol

You may not qualify if:

  • Prior exposure to SNS-595
  • Pregnant or breastfeeding
  • Women of childbearing potential, or male partners of women of childbearing potential, unwilling to use an approved, effective means of contraception according to the institution's standards
  • Other active malignancies or other malignancies within the past 12 months, other than non-melanoma skin cancer, cervical intraepithelial neoplasia, or prostatic intraepithelial neoplasia
  • Q-wave myocardial infarction or cerebrovascular accident/transient ischemic attack (TIA) within 6 months before the first SNS-595 dose
  • Thromboembolic event (deep vein thrombosis or pulmonary embolus) within 28 days before the first SNS-595 dose
  • Requires kidney dialysis (hemodialysis or peritoneal)
  • Prior chemotherapy, investigational agents, or radiation therapy within 28 days before Cycle 1 Day 0; however, nitrosoureas, mitomycin C, and therapeutic monoclonal antibodies are not permitted for at least 42 days before Cycle 1 Day 0
  • In patients with toxicities caused by prior cancer therapy, those toxicities must have returned to less than or equal to Grade 1, with the exception of alopecia.
  • Prior pelvic radiation therapy or radiation to greater than 25% of bone marrow reserve; radiation to the brain is permitted up to 28 days before the first SNS-595 dose, as long as the patient does not require treatment with corticosteroids for symptom control related to brain metastases.
  • Any other medical, psychological, or social condition that, in the opinion of the Principal Investigator, would contraindicate the patient's participation in the clinical trial due to safety or compliance with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

University of California Davis

Sacramento, California, 95817, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University

Baltimore, Maryland, 21231, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

The Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Hopital Charles LeMoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Hopital Laval

Sainte-Foy, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Carcinoma, Small CellSmall Cell Lung CarcinomaCarcinomaNeoplasms

Interventions

vosaroxin

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Limitations and Caveats

Further study is needed to confirm the results due to limited sampling size. Statistical fields are not included here because no statistical testings were performed to compare any of the treatment groups. No p-values or odds ratios were reported.

Results Point of Contact

Title
Mike Johnston, Senior Director Regulatory Affairs
Organization
Sunesis Pharmaceuticals, Inc.
mjohnston@sunesis.com
(650) 266-3727

Study Officials

  • Craig Berman, MD

    Sunesis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2006

First Posted

March 3, 2006

Study Start

February 1, 2006

Primary Completion

August 1, 2007

Study Completion

June 1, 2008

Last Updated

July 26, 2018

Results First Posted

July 26, 2018

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(12)CA(5)