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The purpose of this signal seeking study was is to determine whether treatment with BKM120 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BKM120 | Experimental | BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BKM120 | Drug | BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant Clinical Benefit Response Rate | Clinical benefit rate for patients with solid tumors will be assessed using RECIST 1.1 and will include responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) at >=16 weeks. For hematologic tumors other appropriate hematological response criteria was applied. Response criteria: CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm., PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study, PD= At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response of Partial Response (PR) or Greater. PR=at Least a 30% Decrease in the Sum of Diameters of Target Lesions, Taking as Reference the Baseline Sum Diameters | Overall Response (OR) of Partial Response (PR) or greater is based on local investigator assessment. For patients with solid tumors, the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR. For hematologic tumors other appropriate hematological response criteria apply |
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Inclusion Criteria:
Exclusion Criteria:
Patient had received previous treatment with BKM120 Patient had symptomatic CNS metastases Patient had mood disorder as outlined in Section 5 Patient had received chemotherapy or other anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Associates HOPE Division | Phoenix | Arizona | United States | |||
| Arizona Oncology Associates PC- HAL |
Prior to informed consent, patient was pre-identified to have activation of the P13K pathway confirmed via Genomic Profiling Report and whose disease had progressed on or after standard treatment
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| ID | Title | Description |
|---|---|---|
| FG000 | BKM120 | BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months |
| Progression-Free Survival - Number of Participants With an Event | Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause | Every 8 Weeks until death, assessed up to 24 months |
| Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Timing in Months | Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause | baseline up to 24 months |
| Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Rate in Percentages | Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause. | baseline up to 24 months |
| Overall Survival - Number of Participants With an Event | Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact | Every 8 Weeks until death, assessed up to 24 months |
| Overall Survival (OS)- Kaplan-Meier Estimates of OS Timing in Months | Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact | baseline up to 24 months |
| Overall Survival (OS)- Kaplan-Meier Estimates of OS Rate in Percentages | Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact | baseline up to 30 months |
| Sedona |
| Arizona |
| 86336 |
| United States |
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | United States |
| Sarcoma Oncology Center | Santa Monica | California | 90403 | United States |
| Rocky Mountain Cancer Centers RMCC - Aurora | Greenwood Village | Colorado | United States |
| Whittingham Cancer Center Norwalk Hospital | Norwalk | Connecticut | 06856 | United States |
| Eastern Connecticut Hematology & Oncology Associates The Norwich Cancer Center | Norwich | Connecticut | 06360 | United States |
| Florida Cancer Specialists Dept of Oncology (2) | Fort Myers | Florida | 33901 | United States |
| Florida Hospital Cancer Institute FL Hosp. Cancer Instit. | Orlando | Florida | 32804 | United States |
| Florida Cancer Specialists | West Palm Beach | Florida | 33401 | United States |
| University Cancer & Blood Center, LLC | Athens | Georgia | 30607 | United States |
| Southeastern Regional Medical Center | Newnan | Georgia | 30265 | United States |
| Lurie Children's Hospital of Chicago Developmental Therapeutics | Chicago | Illinois | 60611 | United States |
| Cancer Care Specialists of Central Illinois | Decatur | Illinois | 62526 | United States |
| Illinois Cancer Care P.C. IL. Cancer Care | Peoria | Illinois | 61615-7828 | United States |
| Illinois Cancer Care P.C. | Peoria | Illinois | 61615-7828 | United States |
| Cancer Treatment Centers of America Southwestern Regional Med. Ctr | Schaumburg | Illinois | 60173 | United States |
| Northern Indiana Cancer Research Consortium No. Indiana Cancer Res. | South Bend | Indiana | 46617 | United States |
| University of Iowa Hospitals & Clinics Regulatory Contact 2 | Iowa City | Iowa | 52242 | United States |
| Eastern Maine Medical Center Research Center SC | Bangor | Maine | 04401 | United States |
| Mount Auburn Hospital | Cambridge | Massachusetts | 02138 | United States |
| Michigan Medicine University of Michigan Int. Medicine Oncology | Ann Arbor | Michigan | 48109 5271 | United States |
| Cancer and Hematology Centers of West Michigan Dept. of Oncology | Grand Rapids | Michigan | 49546 | United States |
| Minnesota Oncology Hematology, P.A. Minnesota Oncology Hematology | Minneapolis | Minnesota | 55404 | United States |
| Nebraska Cancer Specialists Oncology Hematology West | Omaha | Nebraska | 68154 | United States |
| Comprehensive Cancer Centers | Las Vegas | Nevada | 89169 | United States |
| Hematology Oncology Associates of Northern New Jersey PA Regional Cancer Care Assoc. | Morristown | New Jersey | 07962 | United States |
| Cancer Center at Presbyterian | Albuquerque | New Mexico | United States |
| New York Oncology Hematology NY Onc Hem | Albany | New York | 12208 | United States |
| Waverly Hematology Oncology | Cary | North Carolina | 27518 | United States |
| University of N C at Chapel Hill Physician Office Building | Chapel Hill | North Carolina | 27599-7600 | United States |
| Duke University Medical Center Seeley G. Mudd Bldg. | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic Foundation Cleveland Clinic (19) | Cleveland | Ohio | 44195 | United States |
| Mid Ohio Oncology/Hematology Mark H. Zangmeister Center | Columbus | Ohio | 43219 | United States |
| Bend Memorial Clinic Bend Mem. Clinic | Bend | Oregon | 97701 | United States |
| Northwest Cancer Specialists Compass Oncology (36) | Portland | Oregon | 97210 | United States |
| Oregon Health and Science University Oregon Health & Science U (56) | Portland | Oregon | 97239 | United States |
| Salem Health | Salem | Oregon | 97309 | United States |
| Gettysburg Cancer Center | Gettysburg | Pennsylvania | 17325 | United States |
| West Penn Allegheny Oncology Network | Natrona Heights | Pennsylvania | 15065 | United States |
| University of Pittsburgh Medical Center UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| Abington Hematology Oncology Associates, Inc Abington Hem Onc Assoc (5) | Willow Grove | Pennsylvania | 19090 | United States |
| Sanford University of South Dakota Medical Center Sanford Health | Sioux Falls | South Dakota | 57104 | United States |
| Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology | Chattanooga | Tennessee | 37404 | United States |
| West Cancer Clinic | Memphis | Tennessee | 38120 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Texas Oncology P A Round Rock | Dallas | Texas | 75251 | United States |
| Texas Oncology Sammons Cancer Center Sammons Cancer Center (10) | Dallas | Texas | 78246 | United States |
| Texas Oncology, P.A. Texas Oncololgy, P.A. (8) | Fort Worth | Texas | 76104 | United States |
| Oncology Consultants Oncology Group | Houston | Texas | 77024 | United States |
| MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (3) | Houston | Texas | 77030 | United States |
| Cancer Care Centers of South Texas HOAST CCC of So. TX-San Antonio (3) | San Antonio | Texas | 78229 | United States |
| Tyler Cancer Center | Tyler | Texas | 75702 | United States |
| Intermountain Medical Center Intermountain Healthcare | Murray | Utah | 84157 | United States |
| Virginia Cancer Specialists Virginia Cancer Specialists | Fairfax | Virginia | 22031 | United States |
| Blue Ridge Research Center at Roanoke Neurological Center McKesson Specialty Care | Roanoke | Virginia | 24018 | United States |
| Kadlec Clinic Hematology and Oncology Kadlec Clinic Hematology & Onc | Kennewick | Washington | 99336 | United States |
| Northwest Medical Specialties Hematology/Oncology | Tacoma | Washington | 98405 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Consented to be Followed for Survival |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BKM120 | BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle |
| 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 | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| ECOG Grade | ECOG Scoring: 0=Fully active, able to carry on all pre-disease performance without restriction, 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light housework, office work, 2=Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours, 3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, Cannot carry on any self-care. Totally confined to bed or chair, 5= Dead | Number | participants |
| ||||||||||||||||||||||
| Protocol pre-defined gene mutation (by local labs) | Number | participants |
| |||||||||||||||||||||||
| Prior Lines of Antineoplastic Medications | Median | Full Range | Number of prior lines of treatment |
|
| 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 | Participant Clinical Benefit Response Rate | Clinical benefit rate for patients with solid tumors will be assessed using RECIST 1.1 and will include responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) at >=16 weeks. For hematologic tumors other appropriate hematological response criteria was applied. Response criteria: CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm., PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study, PD= At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 |
|
|
| ||||||||||||||||||||||||||
| Secondary | Overall Response of Partial Response (PR) or Greater. PR=at Least a 30% Decrease in the Sum of Diameters of Target Lesions, Taking as Reference the Baseline Sum Diameters | Overall Response (OR) of Partial Response (PR) or greater is based on local investigator assessment. For patients with solid tumors, the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR. For hematologic tumors other appropriate hematological response criteria apply | Posted | Number | 95% Confidence Interval | percentage of patients | baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months |
|
| |||||||||||||||||||||||||||
| Secondary | Progression-Free Survival - Number of Participants With an Event | Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause | Posted | Number | participants | Every 8 Weeks until death, assessed up to 24 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Timing in Months | Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause | Posted | Median | 95% Confidence Interval | months | baseline up to 24 months |
|
| |||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Rate in Percentages | Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause. | Posted | Number | 95% Confidence Interval | percentage of participants | baseline up to 24 months |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival - Number of Participants With an Event | Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact | Posted | Number | participants | Every 8 Weeks until death, assessed up to 24 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS)- Kaplan-Meier Estimates of OS Timing in Months | Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact | Posted | Median | 95% Confidence Interval | months | baseline up to 24 months |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS)- Kaplan-Meier Estimates of OS Rate in Percentages | Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact | Posted | Number | 95% Confidence Interval | percentage of participants | baseline up to 30 months |
|
|
Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
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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 | BKM120 | BKM120 | 59 | 146 | 141 | 146 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Anaemia of malignant disease | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oesophageal perforation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Ammonia increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Soft tissue haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Peroneal nerve palsy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
Secondary objective: Duration of response was not analyzed due to low response rate observed
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D019337 | Hematologic Neoplasms |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C571178 | NVP-BKM120 |
Not provided
Not provided
Not provided
| Asian |
|
| Other |
|
| Title |
|---|
| Measurements |
|---|
|
| Grade 2 |
|
| PIK3CA amplification |
|
| PIK3R1 gene mutation |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| participants with an event |
| |||||
| participants censored |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| 1 month |
| |||||
| 2 months |
| |||||
| 3 months |
| |||||
| 4 months |
| |||||
| 5 months |
| |||||
| 6 months |
| |||||
| 9 months |
| |||||
| 12 months |
| |||||
| 18 months |
| |||||
| 24 months |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| participants with an event |
| |||||
| participants censored |
|
|
|