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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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This research study is evaluating a drug called buparlisib (BKM120) as a possible treatment for locally advanced head and neck squamous cell cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level 1 | Experimental |
|
|
| Dose Level 2 | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BKM120 | Drug | BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose of Cisplatin | The trial uses 3+3 design to determine maximum tolerated dose (MTD). | While on treatment, up to 66 days |
| Maximum Tolerated Dose of BKM120 | The trial uses 3+3 design to determine maximum tolerated dose (MTD). | While on treatment, up to 66 days |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response | The best overall response for each patient is given per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) criteria: Complete Response (CR) - Disappearance of all target and non-target lesions and lymph node short axis is <10 mm and no new lesions Partial Response (PR)
Stable Disease (SD) - Less than 5 mm increase in target lesion diameter unless it results in a >=20% increase in diameter and >=1 persisting non-target lesion or tumor marker levels above normal limits and no new lesions Progressive Disease (PD)
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glenn J. Hanna, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33004905 | Derived | Glorieux M, Dok R, Nuyts S. The influence of PI3K inhibition on the radiotherapy response of head and neck cancer cells. Sci Rep. 2020 Oct 1;10(1):16208. doi: 10.1038/s41598-020-73249-z. |
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There are no plans to share the IPD. Cumulative data will be published however.
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September 29, 2014-December 5, 2017
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Level 1 |
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2021 |
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| Cisplatin | Drug | Cisplatin is a chemotherapy drug |
|
|
| Intensity-modulated radiotherapy (IMRT) | Radiation | IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells |
|
|
| Measured at end of treatment, up to 66 days |
| Median Time to Progression | The median amount of time from baseline to progression and/or death. Patients known to be alive at last contact are censored at last contact. All patients alive at 24 months from baseline are censored at 24 months. | Up to 24 months (Progression is defined using RECIST v1.0 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions) |
| 24 Month Overall Survival | The probability of survival at 24 months using Kaplan-Meier estimates. Patients alive at 2 years are censored at 2 years. | Up to 24 months |
| Median Anxiety Score Change | The median change in score on the Generalized Anxiety Disorder - 7 (GAD-7) questionnaire from baseline to cycle 9.GAD-7 has 7 questions and each question has score from 0 to 3. Sum score of all questions will be used as the final score. The final score ranges from 0 to 21. Higher score represents worse anxiety. | From baseline to cycle 9, up to 66 days. |
| Median Depression Score Change | The median change in score on the Patient Health Questionnaire - 9 (PHQ-8) from baseline to cycle 9. PHQ-9 has 9 questions and each question has score from 0 to 3. Sum score of all questions will be used as the final score. The final score ranges from 0 to 27. Higher score represents worse depression. | From baseline to cycle 9, up to 66 days. |
| P13K Status by Response | Phosphoinositide 3-kinase (PI3K) biomarker status, either positive or negative, analyzed using established methods from tumor biopsies. P13K status is reported by response, either responder (CR or PR) or non-responder (SD or PR). | Biopsies drawn up to 10 days from registration. Response measured at from baseline to cycle 9, up to 66 days. |
| FG001 | Dose Level 2 |
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dose Level 1 |
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells |
| BG001 | Dose Level 2 |
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells |
| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Stage | Either of the following indicate Stage 3:
Any of the following indicate Stage 4:
| Count of Participants | Participants |
| |||||||||||||||
| Primary Disease Site | Count of Participants | Participants |
| ||||||||||||||||
| Smoking History | Count of Participants | Participants |
| ||||||||||||||||
| Number of Pack Years | Count of Participants | Participants |
| ||||||||||||||||
| Current Smoker | Count of Participants | 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 | Maximum Tolerated Dose of Cisplatin | The trial uses 3+3 design to determine maximum tolerated dose (MTD). | *One additional patient enrolled in Dose Level 1 per physician discretion | Posted | Number | mg/m2 | While on treatment, up to 66 days |
|
|
| ||||||||||||||||||||||||||
| Secondary | Best Overall Response | The best overall response for each patient is given per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) criteria: Complete Response (CR) - Disappearance of all target and non-target lesions and lymph node short axis is <10 mm and no new lesions Partial Response (PR)
Stable Disease (SD) - Less than 5 mm increase in target lesion diameter unless it results in a >=20% increase in diameter and >=1 persisting non-target lesion or tumor marker levels above normal limits and no new lesions Progressive Disease (PD)
| Posted | Count of Participants | Participants | Measured at end of treatment, up to 66 days |
| |||||||||||||||||||||||||||||
| Secondary | Median Time to Progression | The median amount of time from baseline to progression and/or death. Patients known to be alive at last contact are censored at last contact. All patients alive at 24 months from baseline are censored at 24 months. | Posted | Median | 95% Confidence Interval | months | Up to 24 months (Progression is defined using RECIST v1.0 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions) |
| ||||||||||||||||||||||||||||
| Secondary | 24 Month Overall Survival | The probability of survival at 24 months using Kaplan-Meier estimates. Patients alive at 2 years are censored at 2 years. | Posted | Number | 95% Confidence Interval | probability of survival | Up to 24 months |
| ||||||||||||||||||||||||||||
| Secondary | Median Anxiety Score Change | The median change in score on the Generalized Anxiety Disorder - 7 (GAD-7) questionnaire from baseline to cycle 9.GAD-7 has 7 questions and each question has score from 0 to 3. Sum score of all questions will be used as the final score. The final score ranges from 0 to 21. Higher score represents worse anxiety. | Posted | Median | Full Range | points | From baseline to cycle 9, up to 66 days. |
| ||||||||||||||||||||||||||||
| Secondary | Median Depression Score Change | The median change in score on the Patient Health Questionnaire - 9 (PHQ-8) from baseline to cycle 9. PHQ-9 has 9 questions and each question has score from 0 to 3. Sum score of all questions will be used as the final score. The final score ranges from 0 to 27. Higher score represents worse depression. | Posted | Median | Full Range | points | From baseline to cycle 9, up to 66 days. |
| ||||||||||||||||||||||||||||
| Secondary | P13K Status by Response | Phosphoinositide 3-kinase (PI3K) biomarker status, either positive or negative, analyzed using established methods from tumor biopsies. P13K status is reported by response, either responder (CR or PR) or non-responder (SD or PR). | Biomarker data was not collected for all patients. Data reported for all patients who were biopsied. | Posted | Count of Participants | Participants | Biopsies drawn up to 10 days from registration. Response measured at from baseline to cycle 9, up to 66 days. |
| ||||||||||||||||||||||||||||
| Primary | Maximum Tolerated Dose of BKM120 | The trial uses 3+3 design to determine maximum tolerated dose (MTD). | *One additional patient enrolled in Dose Level 1 per physician discretion | Posted | Number | mg | While on treatment, up to 66 days |
|
|
Measured while on-treatment. From baseline to cycle nine, up to 66 days.
All adverse events data were included in the serious adverse event table as no identifier to indicate SAE/OAE in the dataset, cannot separate them retrospectively.
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 | Dose Level 1 |
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells | 1 | 17 | 17 | 17 | 0 | 0 |
| EG001 | Dose Level 2 |
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells | 1 | 6 | 6 | 6 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Apnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Cardiac disorders - Other, specify | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cholesterol high | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysphasia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema face | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema trunk | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Esophageal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gait disturbance | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hallucinations | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Investigations - Other, specify | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lip infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphedema | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neck edema | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Papulopustular rash | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Psychiatric disorders - Other, specify | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Serum amylase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tooth discoloration | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tracheal fistula | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Voice alteration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Glenn J. Hanna, MD | Dana Farber Cancer Institute | 617.632.6799 | GJHanna@partners.org |
| Apr 11, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D007012 | Hypopharyngeal Neoplasms |
| D007822 | Laryngeal Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D009302 | Nasopharyngeal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C571178 | NVP-BKM120 |
| D002945 | Cisplatin |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Clinical Cancer Stage 4 |
|
| Oral Cavity |
|
| Oropharynx |
|
| Larynx |
|
| Oth |
|
| No |
|
| Less than or equal to 10 |
|
| No |
|
| Dose Level 2 |
BKM120: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor. Cisplatin: Cisplatin is a chemotherapy drug Intensity-modulated radiotherapy (IMRT): IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|