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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00467 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000543528 | |||
| CALGB 30602 | Other Identifier | Cancer and Leukemia Group B | |
| CALGB-30602 | Other Identifier | CTEP | |
| P30CA014236 | U.S. NIH Grant/Contract | View source | |
| U10CA031946 | U.S. NIH Grant/Contract | View source |
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This phase II trial is studying how well dasatinib works in treating patients with relapse small cell lung cancer. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVE I. Determine the efficacy of dasatinib in patients with relapsed small cell lung cancer.
SECONDARY OBJECTIVE II. Determine the objective response rate (complete and partial response) in patients treated with this drug.
III. Determine the overall survival of patients treated with this drug. IV. Determine the toxicity of this drug in these patients.
OUTLINE:
Patients receive oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at least every 3 months for 1 year and then every 6 months for 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (dasatinib) | Experimental | Patients receive oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dasatinib | Drug | Given PO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 6 Week Progression Free Survival | Percentage of patients who were alive and progression free at 6-weeks. The 6-week progression free survival was estimated using the Kaplan Meier method. Progressive Disease was defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria as 20% increase in sum of longest diameter of target lesions. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure. | Time from registration to progression (up to 3 years) |
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Inclusion Criteria:
Histologically or cytologically confirmed small cell lung cancer (SCLC) (limited or extensive stage disease)
Progressive or recurrent disease after an initial response to first-line treatment with a platinum-based chemotherapy with or without concurrent definitive radiotherapy to the chest (chemotherapy must have been completed at least 90 days prior to documentation of relapse)
Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
Lesions that are not considered measurable include the following:
No known brain metastases (previously treated brain metastases allowed provided they are neurologically stable for >= 4 weeks)
ECOG performance status 0-1
Platelet count >= 100,000/mm^3
Bilirubin =< 1.5 times upper limit of normal (ULN)
Creatinine =< 1.5 times ULN OR creatinine clearance >= 60 mL/min
AST =< 2.5 times ULN
Not pregnant or nursing
Negative pregnancy test
No significant cardiac disease, including any of the following:
No more than 1 prior chemotherapy regimen
No prior dasatinib or compounds of similar chemical composition or similar biologic therapeutic activity including, but not limited to, any inhibitors of SRC, BCR-ABL, c-KIT, EPHA2, or PDGFRB kinases
At least 2 weeks since prior definitive or palliative radiotherapy (prior radiotherapy allowed in the context of combined modality treatment with curative intent for limited stage disease; prophylactic cranial radiotherapy; or palliative radiotherapy initially or at relapse)
At least 2 weeks since prior surgery and recovered
At least 1 week since prior and no concurrent agents with proarrhythmic potential
At least 1 week since prior and no concurrent CYP3A4 inhibitors or inducers
At least 1 week since prior and no concurrent grapefruit concentrate
No concurrent palliative radiotherapy
No concurrent hormones or other chemotherapeutic agents, except steroids for adrenal failure, hormones for noncancer-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
No concurrent combination antiretroviral therapy for HIV-positive patients
No other concurrent chemotherapeutic or investigational agents
Fertile patients must use effective contraception during and for >= 6 weeks after completion of study therapy
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| Name | Affiliation | Role |
|---|---|---|
| Antonius Miller | Cancer and Leukemia Group B | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer and Leukemia Group B | Chicago | Illinois | 60606 | United States |
One(1) participant cancelled before receiving any protocol related therapy and 1 participant was deemed ineligible. All participants receiving treatment were analyzed for adverse events and only eligible (43) participants were analyzed for al other endpoints.
Between July 2007 and December 2008, 45 participants were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dasatinib | Pts receive oral dasatinib 70 mg twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only eligible participants (those who met the criteria for inclusion) were evaluated for baseline characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dasatinib | Pts receive oral dasatinib 70 mg twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 6 Week Progression Free Survival | Percentage of patients who were alive and progression free at 6-weeks. The 6-week progression free survival was estimated using the Kaplan Meier method. Progressive Disease was defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria as 20% increase in sum of longest diameter of target lesions. | All eligible participants were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 weeks |
|
|
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All 44 participants who received treatment were analyzed (including ineligible participants).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dasatinib | Pts receive oral dasatinib 70 mg twice daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antonius Miller | Wake Forest University | aamiller@wfubmc.edu |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Response to Therapy |
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:
|
| Assessed every 2 cycles (up to 3 years) |
| Overall Survival | Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method. | Time from registration to death (up to 3 years) |
| Number of Participants With Grade 3 or Higher Adverse Events | The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 was used to evaluate toxicity. Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death. | Assessed during treatment |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ECOG Performance Status | Classifies patients according to their functional impairment. Scores range from 0 (fully active) to 5 (death). | Number | participants |
|
| Participants |
|
|
| Secondary | Progression Free Survival (PFS) | PFS was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure. | All eligible participants were analyzed. | Posted | Median | 95% Confidence Interval | weeks | Time from registration to progression (up to 3 years) |
|
|
|
| Secondary | Response to Therapy | Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:
| All eligible participants were analyzed. | Posted | Number | participants | Assessed every 2 cycles (up to 3 years) |
|
|
|
| Secondary | Overall Survival | Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method. | All eligible participants were analyzed. | Posted | Median | 95% Confidence Interval | weeks | Time from registration to death (up to 3 years) |
|
|
|
| Secondary | Number of Participants With Grade 3 or Higher Adverse Events | The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 was used to evaluate toxicity. Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death. | All 44 participants who received treatment were analyzed (including ineligible participants). | Posted | Number | participants | Assessed during treatment |
|
|
|
| 14 |
| 44 |
| 39 |
| 44 |
| Lymph node pain | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
|
| Cardiac ischemia/infarction | Cardiac disorders | MedDRA 6 | Systematic Assessment |
|
| Left ventricular diastolic dysfunction | Cardiac disorders | MedDRA 6 | Systematic Assessment |
|
| Left ventricular systolic dysfunction | Cardiac disorders | MedDRA 6 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 6 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Pain | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Death not associated with CTCAE term | General disorders | MedDRA 6 | Systematic Assessment |
|
| Edema: limb | General disorders | MedDRA 6 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 6 | Systematic Assessment |
|
| Fever | General disorders | MedDRA 6 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Alkaline phosphatase | Investigations | MedDRA 6 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Cholesterol serum-high (hypercholesteremia) | Investigations | MedDRA 6 | Systematic Assessment |
|
| Creatinine | Investigations | MedDRA 6 | Systematic Assessment |
|
| Leukocytes (total WBC) | Investigations | MedDRA 6 | Systematic Assessment |
|
| Lymphopenia | Investigations | MedDRA 6 | Systematic Assessment |
|
| Neutrophils/granulocytes (ANC/AGC) | Investigations | MedDRA 6 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Prolonged QTc interval | Investigations | MedDRA 6 | Systematic Assessment |
|
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Calcium serum-low (hypocalcemia) | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Glucose serum-high (hyperglycemia) | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Magnesium serum-high (hypermagnesemia) | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Magnesium serum-low (hypomagnesemia) | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Phosphate serum-low (hypophosphatemia) | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Potassium serum-high (hyperkalemia) | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Potassium serum-low (hypokalemia) | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Sodium serum-low (hyponatremia) | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
|
| Confusion | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Tracheal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 6 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 6 | Systematic Assessment |
|
| Lymphatics - Other | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 6 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 6 | Systematic Assessment |
|
| Ocular/Visual - Other | Eye disorders | MedDRA 6 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Pain | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Death NOS | General disorders | MedDRA 6 | Systematic Assessment |
|
| Death not associated with CTCAE term | General disorders | MedDRA 6 | Systematic Assessment |
|
| Edema: limb | General disorders | MedDRA 6 | Systematic Assessment |
|
| Edema:head and neck | General disorders | MedDRA 6 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 6 | Systematic Assessment |
|
| Fever | General disorders | MedDRA 6 | Systematic Assessment |
|
| Syndromes - Other | General disorders | MedDRA 6 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Alkaline phosphatase | Investigations | MedDRA 6 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Bilirubin (hyperbilirubinemia) | Investigations | MedDRA 6 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Creatinine | Investigations | MedDRA 6 | Systematic Assessment |
|
| INR (International Normalized Ratio of prothrombin time) | Investigations | MedDRA 6 | Systematic Assessment |
|
| Lymphopenia | Investigations | MedDRA 6 | Systematic Assessment |
|
| Neutrophils/granulocytes (ANC/AGC) | Investigations | MedDRA 6 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Prolonged QTc interval | Investigations | MedDRA 6 | Systematic Assessment |
|
| Weight loss | Investigations | MedDRA 6 | Systematic Assessment |
|
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Calcium serum-high (hypercalcemia) | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Glucose serum-high (hyperglycemia) | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Potassium serum-low (hypokalemia) | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Sodium serum-low (hyponatremia) | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Arthritis (non-septic) | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Muscle weakness, generalized or specific area (not due to neuropathy) | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA 6 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| Title | Measurements |
|---|---|
|
| Progression |
|
| Inadequately assessed |
|