Safety and Efficacy Clinical Study of SNS-595 in Patients With Advanced Small Cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00298896
• Other study ID #: SPO-0006
• Status: Completed
• Phase: Phase 2
• Start date: February 2006
• Est. completion date: June 2008

Study information

• Verified date: October 2017
• Source: Sunesis Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

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, 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

Related Conditions & MeSH terms

• Carcinoma, Small Cell
• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• SNS-595

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Hopital Charles LeMoyne	Greenfield Park	Quebec
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	Hopital Laval	Sainte-Foy	Quebec
Canada	BC Cancer Agency	Vancouver	British Columbia
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Rush University Medical Center	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	The Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	University of California Davis	Sacramento	California
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Sunesis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Best Overall Response	The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started), classified as CR, PR, SD or PD per RECIST criteria.	upto 6 months