Trial Outcomes & Findings for Safety and Efficacy Clinical Study of SNS-595 for Second-Line Therapy in Patients With Advanced NSCLC (NCT NCT00252382)
NCT ID: NCT00252382
Last Updated: 2018-09-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
168 days
Results posted on
2018-09-24
Participant Flow
Participant milestones
| Measure |
Treatment With 48 mg/m2 of SNS-595
Patients are treated with 48 mg/m2 of the drug SNS-595 injection once every 21 days for up to 6 cycles as a second -line therapy to patients with advanced non-small cell lung cancer (NSCLC)
SNS-595 Injection: Vosaroxin (formerly voreloxin or SNS-595) is a first in class anticancer quinolone derivative, non anthracycline topoisomerase II inhibitor. It induces replication dependent DNA damage by intercalating DNA and inhibiting topoisomerase II, leading to apoptosis.
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Clinical Study of SNS-595 for Second-Line Therapy in Patients With Advanced NSCLC
Baseline characteristics by cohort
| Measure |
Total
n=31 Participants
Open label administration of SNS-595 48 mg/m2 treatment on day one of 21 day cycles, up to 6 cycles.
|
|---|---|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 9.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 168 daysPopulation: Efficacy Analysis Population
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.
Outcome measures
| Measure |
Total
n=26 Participants
SNS-595 48 mg/m2
|
|---|---|
|
Objective Tumor Response Rate
|
1 Participants
|
SECONDARY outcome
Timeframe: 168 daysPopulation: Efficacy Analysis Population
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 of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started).
Outcome measures
| Measure |
Total
n=26 Participants
SNS-595 48 mg/m2
|
|---|---|
|
Best Overall Response
Partial Response
|
1 Participants
|
|
Best Overall Response
Progressive Disease
|
17 Participants
|
|
Best Overall Response
Stable Disease
|
8 Participants
|
Adverse Events
Total
Serious events: 6 serious events
Other events: 30 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Total
n=31 participants at risk
SNS-595 48 mg/m2
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.2%
1/31 • 196 days
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.2%
1/31 • 196 days
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
1/31 • 196 days
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
1/31 • 196 days
|
|
Infections and infestations
Pneumonia
|
6.5%
2/31 • 196 days
|
|
Infections and infestations
Pneumonia pneumococcal
|
3.2%
1/31 • 196 days
|
|
Psychiatric disorders
Depression
|
3.2%
1/31 • 196 days
|
|
Renal and urinary disorders
Renal failure
|
3.2%
1/31 • 196 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.2%
1/31 • 196 days
|
Other adverse events
| Measure |
Total
n=31 participants at risk
SNS-595 48 mg/m2
|
|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.5%
2/31 • 196 days
|
|
Gastrointestinal disorders
Hiatus hernia
|
3.2%
1/31 • 196 days
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
3.2%
1/31 • 196 days
|
|
Gastrointestinal disorders
Intestinal obstruction
|
3.2%
1/31 • 196 days
|
|
Gastrointestinal disorders
Lip disorder
|
3.2%
1/31 • 196 days
|
|
Gastrointestinal disorders
Nausea
|
54.8%
17/31 • 196 days
|
|
Gastrointestinal disorders
Oesophagitis
|
3.2%
1/31 • 196 days
|
|
Gastrointestinal disorders
Proctalgia
|
3.2%
1/31 • 196 days
|
|
Gastrointestinal disorders
Rectal spasm
|
3.2%
1/31 • 196 days
|
|
Gastrointestinal disorders
Stomatitis
|
3.2%
1/31 • 196 days
|
|
Gastrointestinal disorders
Vomiting
|
19.4%
6/31 • 196 days
|
|
General disorders
Asthenia
|
12.9%
4/31 • 196 days
|
|
General disorders
Chest discomfort
|
3.2%
1/31 • 196 days
|
|
General disorders
Chills
|
3.2%
1/31 • 196 days
|
|
General disorders
Disease progression
|
3.2%
1/31 • 196 days
|
|
General disorders
Fatigue
|
67.7%
21/31 • 196 days
|
|
General disorders
Non-cardiac chest pain
|
12.9%
4/31 • 196 days
|
|
General disorders
Oedema peripheral
|
16.1%
5/31 • 196 days
|
|
General disorders
Pain
|
3.2%
1/31 • 196 days
|
|
General disorders
Pyrexia
|
3.2%
1/31 • 196 days
|
|
Infections and infestations
Fungal infection
|
3.2%
1/31 • 196 days
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
1/31 • 196 days
|
|
Infections and infestations
Oral candidiasis
|
19.4%
6/31 • 196 days
|
|
Infections and infestations
Sinusitis
|
6.5%
2/31 • 196 days
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
1/31 • 196 days
|
|
Infections and infestations
Urinary tract infection
|
3.2%
1/31 • 196 days
|
|
Investigations
Breath sounds abnormal
|
3.2%
1/31 • 196 days
|
|
Metabolism and nutrition disorders
Anorexia
|
19.4%
6/31 • 196 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.2%
1/31 • 196 days
|
|
Metabolism and nutrition disorders
Dehydration
|
12.9%
4/31 • 196 days
|
|
Metabolism and nutrition disorders
Failure to thrive
|
3.2%
1/31 • 196 days
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.2%
1/31 • 196 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.2%
1/31 • 196 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.2%
1/31 • 196 days
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.2%
1/31 • 196 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.2%
1/31 • 196 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.4%
6/31 • 196 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.9%
4/31 • 196 days
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.2%
1/31 • 196 days
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
6.5%
2/31 • 196 days
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.2%
1/31 • 196 days
|
|
Musculoskeletal and connective tissue disorders
Metastases to bone
|
3.2%
1/31 • 196 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.5%
2/31 • 196 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.2%
1/31 • 196 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.5%
2/31 • 196 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.2%
1/31 • 196 days
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
3.2%
1/31 • 196 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.5%
2/31 • 196 days
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
6.5%
2/31 • 196 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
6.5%
2/31 • 196 days
|
|
Nervous system disorders
Coordination abnormal
|
3.2%
1/31 • 196 days
|
|
Nervous system disorders
Dizziness
|
6.5%
2/31 • 196 days
|
|
Nervous system disorders
Headache
|
3.2%
1/31 • 196 days
|
|
Nervous system disorders
Metabolic Encephalopathy
|
3.2%
1/31 • 196 days
|
|
Nervous system disorders
Migraine
|
3.2%
1/31 • 196 days
|
|
Nervous system disorders
Sensory loss
|
3.2%
1/31 • 196 days
|
|
Nervous system disorders
Sinus headache
|
3.2%
1/31 • 196 days
|
|
Nervous system disorders
Somnolence
|
3.2%
1/31 • 196 days
|
|
Psychiatric disorders
Anxiety
|
3.2%
1/31 • 196 days
|
|
Psychiatric disorders
Confusional state
|
6.5%
2/31 • 196 days
|
|
Psychiatric disorders
Depression
|
12.9%
4/31 • 196 days
|
|
Psychiatric disorders
Insomnia
|
9.7%
3/31 • 196 days
|
|
Psychiatric disorders
Mental status changes
|
3.2%
1/31 • 196 days
|
|
Renal and urinary disorders
Dysuria
|
6.5%
2/31 • 196 days
|
|
Renal and urinary disorders
Haematuria
|
3.2%
1/31 • 196 days
|
|
Renal and urinary disorders
Micturition disorder
|
3.2%
1/31 • 196 days
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.2%
1/31 • 196 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.9%
4/31 • 196 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.7%
3/31 • 196 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.5%
2/31 • 196 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
3.2%
1/31 • 196 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.9%
4/31 • 196 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.2%
1/31 • 196 days
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.2%
1/31 • 196 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.1%
5/31 • 196 days
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.5%
2/31 • 196 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.2%
1/31 • 196 days
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
3.2%
1/31 • 196 days
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
3.2%
1/31 • 196 days
|
|
Surgical and medical procedures
Nasal sinus drainage
|
3.2%
1/31 • 196 days
|
|
Vascular disorders
Deep vein thrombosis
|
3.2%
1/31 • 196 days
|
|
Gastrointestinal disorders
Constipation
|
25.8%
8/31 • 196 days
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
1/31 • 196 days
|
|
Gastrointestinal disorders
Dysphagia
|
3.2%
1/31 • 196 days
|
|
Blood and lymphatic system disorders
Anaemia
|
35.5%
11/31 • 196 days
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.7%
3/31 • 196 days
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.5%
2/31 • 196 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.1%
5/31 • 196 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.5%
2/31 • 196 days
|
|
Cardiac disorders
Tachycardia
|
6.5%
2/31 • 196 days
|
|
Ear and labyrinth disorders
Vertigo
|
3.2%
1/31 • 196 days
|
|
Eye disorders
Dry eye
|
3.2%
1/31 • 196 days
|
|
Eye disorders
Vision blurred
|
6.5%
2/31 • 196 days
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.2%
1/31 • 196 days
|
|
Gastrointestinal disorders
Abdominal pain
|
19.4%
6/31 • 196 days
|
|
Gastrointestinal disorders
Abdominal tenderness
|
3.2%
1/31 • 196 days
|
Additional Information
Mike Johnston, Senior Director Regulatory Affairs
Sunesis Pharmaceuticals, Inc.
Phone: (650) 266-3727
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60