Carcinoma, Small Cell, Small Cell Lung Cancer
Conditions
Keywords
Lung, Squamous Cell, Small Cell, Carcinoma, Cancer, Small Cell Lung Cancer
Brief 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).
Detailed 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.
Interventions
DRUGSNS-595
Sponsors
Sunesis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | up to 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Overall Response | upto 6 months | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SNS-595 SNS-595; 48 mg/m2 administered IV once every 21 days for up to 6 cycles. | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Assigned to treatment in error | 1 |
| Overall Study | Death | 3 |
| Overall Study | Disease Progression | 41 |
| Overall Study | Intercurrent Illness | 1 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | SNS-595 |
|---|---|
| Age, Continuous | 61.2 years STANDARD_DEVIATION 9.46 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 54 Participants |
| Region of Enrollment Canada | 14 participants |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 15 / 54 |
| other Total, other adverse events | 52 / 54 |
| serious Total, serious adverse events | 9 / 54 |
Outcome results
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
Time frame: up to 6 months
Population: Efficacy Analysis Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SNS-595 | Objective Response Rate | 3 Participants |
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.
Time frame: upto 6 months
Population: Efficacy Analysis Set
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SNS-595 | Best Overall Response | Complete Response | 1 Participants |
| SNS-595 | Best Overall Response | Partial Response | 2 Participants |
| SNS-595 | Best Overall Response | Progressive Disease | 31 Participants |
| SNS-595 | Best Overall Response | Stable Disease | 13 Participants |