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Safety and Efficacy Clinical Study of SNS-595 for Second-Line Therapy in Patients With Advanced NSCLC
Phase 2 trial testing SNS-595 Injection in Carcinoma, Non-Small-Cell Lung in 31 participants. Completed in 29 November 2007.
| Lead sponsor | Sunesis Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 31 |
| Start date | 27 December 2005 |
| Primary completion | 5 March 2007 |
| Estimated completion | 29 November 2007 |
| Sites | 4 locations across United States |
Sunesis Pharmaceuticals — full company profile →
18 and older, any sex, with Carcinoma, Non-Small-Cell Lung. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
ORR is based on RECIST criteria to SNS-595 as a second-line therapy in patients with advanced NSCLC. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Group | Value | 95% CI |
|---|---|---|
| Total | 1 |
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (LD) of target lesions; \>=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions (PD); Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (SD). The best overall response is the best response recorded from the start o
| Group | Value | 95% CI |
|---|---|---|
| Total | 1 | |
| Total | 17 | |
| Total | 8 |
Time frame: 196 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Total |
|---|---|---|
| Pneumonia | Infections and infestations | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Leukopenia | Blood and lymphatic system disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Pneumonia pneumococcal | Infections and infestations | — |
| Depression | Psychiatric disorders | — |
| Renal failure | Renal and urinary disorders | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | Total |
|---|---|---|
| Fatigue | General disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Oral candidiasis | Infections and infestations | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Neutropenia | Blood and lymphatic system disorders | — |
| Oedema peripheral | General disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| Asthenia | General disorders | — |
| Non-cardiac chest pain | General disorders | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Depression | Psychiatric disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Productive cough | Respiratory, thoracic and mediastinal disorders | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Insomnia | Psychiatric disorders | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Leukopenia | Blood and lymphatic system disorders | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Tachycardia | Cardiac disorders | — |
| Vision blurred | Eye disorders | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — |
| Sinusitis | Infections and infestations | — |
| Chest wall pain | Musculoskeletal and connective tissue disorders | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
| Shoulder pain | Musculoskeletal and connective tissue disorders | — |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Dizziness | Nervous system disorders | — |
| Confusional state | Psychiatric disorders | — |
| Dysuria | Renal and urinary disorders | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — |
| Night sweats | Skin and subcutaneous tissue disorders | — |
| Vertigo | Ear and labyrinth disorders | — |
Most-reported serious reactions: Pneumonia, Febrile neutropenia, Leukopenia, Abdominal pain, Vomiting, Pneumonia pneumococcal, Depression, Renal failure.
Data from ClinicalTrials.gov NCT00252382 adverse events section.
The purpose of this study is to evaluate the objective tumor response rate (based on the RECIST criteria) to SNS-595 as a second-line therapy in patients with advanced NSCLC.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing