Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Lung Neoplasms

Carcinoma

Small Cell Lung Carcinoma

Carcinoma, Small Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

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

SNS-595

Craig Berman, MD

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

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.

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

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)

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

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.

Sunesis Pharmaceuticals

One enrolled patient removed from assessment due to error in admission to study (prior to study drug administration) and is therefore not included in the "Participants at Risk" data (54 of 55 participants).

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

SNS-595

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Canada

United States

Region of Enrollment

Patients with advanced platinum-sensitive or refractory small cell lung cancer (SCLC) requiring second-lie chemotherapy after prior first-line therapy.

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.

Spots Global Cancer Trial Database for Safety and Efficacy Clinical Study of SNS-595 in Patients With Advanced Small Cell Lung Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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