Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003128-11 | EudraCT Number |
Not provided
Not provided
Not provided
Lack of efficacy and slow accrual
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to establish whether patients with malignancy harboring a discoidin domain receptor 2 mutation or an inactivating B-RAF mutation will respond to dasatinib.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) | Experimental | Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred |
|
| Dasatinib, 140 mg (NSCLC With DDR2 Mutation) | Experimental | Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib | Drug | Tablet, oral, 140 mg, once daily until unacceptable toxicity or disease progression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the percentage of patients with best tumor response of either Partial Response (a 30% or greater decrease in the sum of the longest diameter [LD] of all lesions in reference to the baseline sum LD) or Complete Response (disappearance of clinical and radiologic evidence of target lesions), according to Response Evaluation Criteria in Solid Tumors. | From enrollment of last patient to 24 months or until all patients have died, whichever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | DOR is defined as the time from the first assessment documentation of partial response (PR) or complete response (CR) until the first assessment documentation of disease progression. | From enrollment of last patient to 24 months or until all patients have died, whichever occurs first |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria
Diagnosis of advanced malignancy, nonsmall-cell lung cancer (NSCLC) only during stage 1 of accrual.
Nonsynonymous mutation of B-RAF or DDR2, defined as follows:.
i) NSCLC with inactivating B-RAF mutation.
ii) NSCLC with discoidin domain receptor 2 (DDR2) mutation.
iii) Malignancy of other histology with DDR2 mutation or inactivating B-RAF mutation, or NSCLC having a B-RAF mutation that is not functionally characterized.
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer & Research Institute | Tampa | Florida | 33612 | United States | ||
| Memorial Sloan Kettering Cancer Center |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
A total of 19 patients were enrolled, and 14 received treatment in 2 cohorts: 9 with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation and 5 with NSCLC and a discoidin domain receptor 2 (DDR2) mutation.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) | Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred |
| FG001 | Dasatinib, 140 mg (NSCLC With DDR2 Mutation) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Overall Survival |
Overall survival is defined as the time from treatment start date to the date of death. If a patient does not die, survival will be censored on the last date the patient was known to be alive. |
| From enrollment of last patient to 24 months or until all patients have died, whichever occurs first |
| Progression-free Survival (PFS) Distribution | PFS distribution is defined as the percentage of patients with no documentation of disease progression at a specified time point. Confidence interval computed using the Brookmeyer and Crowley method | From Day 1 of study treatment to Week 12 |
| Progression-free Survival (PFS) | PFS is defined as the time from treatment start date to the earliest evidence of disease progression or death. Patients who die or whose disease does not progress will be censored on the date of their last tumor assessment. | From Day 1 of study treatment to Week 12 |
| Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or unknown relationship to study drug. | From enrollment of last patient to 24 months or until all patients have died, whichever occurs first |
| Number of Participants With Laboratory Testing Results That Meet the Criteria for Grade 3 or 4 Abnormality | Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to adverse event. Laboratory values graded by Common Terminology Criteria for Adverse Events, volume 3. Hemoglobin, Grade 3: <8.0 - 6.5 g/dL, <4.9-4.0 mmol/L, <80-65 g/L. Alkaline phosphatase, Grade 3: >5.0-20.0*upper limit of normal (ULN). Total bilirubin, Grade 3: >3.0-10.0*ULN. Calcium, low, Grade 3: <7.0-6.0 mg/dL, <1.75-1.5 mmol/L. | From enrollment of last patient to 24 months or until all patients have died, whichever occurs first |
| New York |
| New York |
| 10065 |
| United States |
| Memorial Sloan Kettering Nassau | New York | New York | 10065 | United States |
| Local Institution | Barretos | São Paulo | 14784-400 | Brazil |
| Local Institution | Barretos | São Paulo | 14784 | Brazil |
| Local Institution | S?o Paulo | São Paulo | 05403 | Brazil |
| Local Institution | São Paulo | 01246-000 | Brazil |
| The Ottawa Hospital Cancer Centre | Ottawa | Ontario | K1H 8L6 | Canada |
| Local Institution | Cologne | 50924 | Germany |
| Local Institution | Cologne | 50931 | Germany |
| Local Institution | Frankfurt | 60488 | Germany |
| Local Institution | Heidelberg | 69120 | Germany |
| Local Institution | Heidelberg | 69126 | Germany |
| Local Institution | Gdansk | 80-219 | Poland |
| Local Institution | Lodz | 93-509 | Poland |
| Local Institution | Warsaw | 02-781 | Poland |
| Local Institution | Taipei | 112 | Taiwan |
| Local Institution | Cambridge | Cambridgeshire | CB2 2QQ | United Kingdom |
| Local Institution | London | Greater London | SW3 6JJ | United Kingdom |
| Local Institution | Manchester | Greater Manchester | M20 4BX | United Kingdom |
| Local Institution | Gwent | Gwent | NP20 2UB | United Kingdom |
| Local Institution | Edinburgh | Midlothian | EH4 2XU | United Kingdom |
| Local Institution | Sutton | Surrey | SM2 5PT | United Kingdom |
| Local Institution | Cambridge | CB2 2QQ | United Kingdom |
Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who received at least 1 dose of study drug
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation) | Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred |
| BG001 | Dasatinib, 140 mg (NSCLC With DDR2 Mutation) | Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||||
| Time from cancer diagnosis to start of study therapy | Median | Full Range | Months |
| |||||||||||||||||
| Tumor Type | Number | Participants |
| ||||||||||||||||||
| Nonsmall-cell lung carcinoma histology | Number | Participants |
| ||||||||||||||||||
| Histopathologic Grade | Number | Participants |
| ||||||||||||||||||
| Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG is a 6-item scale used to assess disease progression, daily functioning, and appropriate treatment and prognosis. Performance status is scored on a scale ranging from 0-5, with (best score) 0=fully active and able to carry on all predisease performance without restriction and (worst score) 5=death. | Number | Participants |
| |||||||||||||||||
| Number of Index Lesions | Number | Participants |
|
| 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 | Objective Response Rate (ORR) | ORR is defined as the percentage of patients with best tumor response of either Partial Response (a 30% or greater decrease in the sum of the longest diameter [LD] of all lesions in reference to the baseline sum LD) or Complete Response (disappearance of clinical and radiologic evidence of target lesions), according to Response Evaluation Criteria in Solid Tumors. | All participants who received at least 1 dose of study drug. Because no patients had a response of CR or PR, ORR could not be calculated. | Posted | From enrollment of last patient to 24 months or until all patients have died, whichever occurs first |
|
| ||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR is defined as the time from the first assessment documentation of partial response (PR) or complete response (CR) until the first assessment documentation of disease progression. | All participants who received at least 1 dose of study drug. Because no patients had a response of CR or PR, DOR could not be calculated. | Posted | From enrollment of last patient to 24 months or until all patients have died, whichever occurs first |
|
| ||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival is defined as the time from treatment start date to the date of death. If a patient does not die, survival will be censored on the last date the patient was known to be alive. | All participants who received treatment | Posted | Median | 90% Confidence Interval | Months | From enrollment of last patient to 24 months or until all patients have died, whichever occurs first |
|
| |||||||||||||||||||
| Secondary | Progression-free Survival (PFS) Distribution | PFS distribution is defined as the percentage of patients with no documentation of disease progression at a specified time point. Confidence interval computed using the Brookmeyer and Crowley method | All participants who received at least 1 dose of study drug | Posted | Median | 90% Confidence Interval | Percentage of participants | From Day 1 of study treatment to Week 12 |
|
| |||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | PFS is defined as the time from treatment start date to the earliest evidence of disease progression or death. Patients who die or whose disease does not progress will be censored on the date of their last tumor assessment. | All participants who received at least 1 dose of study drug | Posted | Median | 90% Confidence Interval | Months | From Day 1 of study treatment to Week 12 |
|
| |||||||||||||||||||
| Secondary | Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or unknown relationship to study drug. | All participants who received at least 1 dose of study drug | Posted | Number | Participants | From enrollment of last patient to 24 months or until all patients have died, whichever occurs first |
| |||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Testing Results That Meet the Criteria for Grade 3 or 4 Abnormality | Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to adverse event. Laboratory values graded by Common Terminology Criteria for Adverse Events, volume 3. Hemoglobin, Grade 3: <8.0 - 6.5 g/dL, <4.9-4.0 mmol/L, <80-65 g/L. Alkaline phosphatase, Grade 3: >5.0-20.0*upper limit of normal (ULN). Total bilirubin, Grade 3: >3.0-10.0*ULN. Calcium, low, Grade 3: <7.0-6.0 mg/dL, <1.75-1.5 mmol/L. | All participants who received study drug. | Posted | Number | Participants | From enrollment of last patient to 24 months or until all patients have died, whichever occurs first |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dasatinib, 140 mg | Participants with nonsmall-cell lung cancer received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred. Data from both arms were combined for safety reporting, because the safety profile of dasatinib should not have be affected by the type of mutation in the tumor. In addition, pooling the data from both arms increased the robustness of the data set. | 11 | 14 | 13 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Panic reaction | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood alkaline phosphatase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hepatic pain | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Calcium ionised increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Nasal ulcer | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Parosmia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Extravasation | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Electrocardiogram ST segment elevation | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary straining | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
The study was terminated due to lack of efficacy and slow enrollment of patients.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic/Latino |
|
| Not reported |
|
| Other |
|
| Bronco-alveolar carcinoma |
|
| Large cell carcinoma |
|
| Squamous cell carcinoma |
|
| G3-poorly differentiated |
|
| GX-grade cannot be assessed |
|
| ECOG score 1 |
|
| ECOG score 2 |
|
| 2 |
|
| 3 |
|
| 4 |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|