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Phase 2 Open-Label, Multicenter Clinical Study of the Safety and Efficacy of the Intravenous Administration of SNS-595 as Second-Line Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

Phase 2 Open-Label, Multicenter Clinical Study of the Safety and Efficacy of the Intravenous Administration of SNS-595 as Second-Line Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)


Other objectives of this study are to assess the safety, tumor response, time to disease
progression, survival rate and to explore several potential biomarkers to see how these
levels change after administration of SNS-595.


Inclusion Criteria:



- Able to understand and willing to sign a written informed consent document

- Patients who have recurrent or metastatic NSCLC, who have failed initial therapy with
a platinum-containing regimen and have not received any second-line therapy (adjuvant
therapy is acceptable if it was completed greater than or equal to 12 months before
the cancer recurrence)

- Measurable disease

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

- Laboratory Values within the normal or reasonable reference range as specified by the
protocol

Exclusion Criteria:

- 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 except
non-melanoma skin cancer, cervical intraepithelial neoplasia or prostatic
intraepithelial neoplasia

- Brain metastases, if present, without radiologic evidence of progressive disease for
at least 3 months after completion of therapy

- Myocardial infarction, cerebrovascular accident/transient ischemic attack (TIA) or
thromboembolic event (deep vein thrombosis or pulmonary embolus) within 6 months
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 and mitomycin 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 or equal to 25% of bone
marrow reserve (prior palliative radiation is permitted as long as it does not exceed
25% of bone marrow reserve)

- 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 concerns or compliance with study procedures

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Efficacy

Principal Investigator

Glenn Michelson, MD

Investigator Role:

Study Director

Investigator Affiliation:

Sunesis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

SPO-0005

NCT ID:

NCT00252382

Start Date:

November 2005

Completion Date:

April 2007

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Lung
  • Squamous Cell
  • Large Cell
  • Adenocarcinoma
  • Carcinoma
  • Cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung

Name

Location

Consultants in Blood Disorders and CancerLouisville, Kentucky  40207
Premiere Oncology of ArizonaScottsdale, Arizona  85260
Duke Comprehensive Cancer Center, Duke UniversityDurham, North Carolina  27705
Sarah Cannon Research Institute, LLCNashville, Tennessee  37203