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| Name | Class |
|---|---|
| National Comprehensive Cancer Network | NETWORK |
| Novartis | INDUSTRY |
In this study, the investigator's want to find out if dabrafenib can stop stage IIIC melanoma from coming back after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dabrafenib | Experimental | This is a single institution phase II trial assessing the efficacy of adjuvant dabrafenib (GSK2118436) in patients with surgically resected AJCC stage IIIC melanoma characterized by a BRAFV600E/K mutation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabrafenib | Drug | Following definitive surgical resection, eligible patients will receive dabrafenib at 150 mg twice a day by mouth for 4 cycles (± 5 days). One cycle is 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Relapse Free Survival | Relapse free survival is defined as the time from surgical resection to the first recurrence or death as assessed by physical examination and radiographic evaluation. All recurrences will be confirmed by biopsy and histologic evaluation. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival is defined as the time from surgical resection to death or last follow-up. | 2 years |
| Number of Participants With Adverse Events | Toxicity will be graded by the NCI Common Toxicity Criteria (CTC) version 4.0 with each cycle of adjuvant dabrafenib. |
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Inclusion Criteria:
Absolute neutrophil count ≥1.5 K/mcL Platelets ≥ 100 K/mcL Hemoglobin ≥ 9.0 g/dL Total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN)
≤ 3.0 X institutional ULN if the patient has Gilbert's Syndrome AST (SGOT) and ALT (SGPT) ≤ 2.5 X institutional ULN Creatinine ≤ 1.5 X institutional ULN or creatinine clearance (calculated or measured) > 60 ml/min
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Chapman, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dabrafenib | This is a single institution phase II trial assessing the efficacy of adjuvant dabrafenib (GSK2118436) in patients with surgically resected AJCC stage IIIC melanoma characterized by a BRAFV600E/K mutation. Dabrafenib: Following definitive surgical resection, eligible patients will receive dabrafenib at 150 mg twice a day by mouth for 4 cycles (± 5 days). One cycle is 28 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dabrafenib | This is a single institution phase II trial assessing the efficacy of adjuvant dabrafenib (GSK2118436) in patients with surgically resected AJCC stage IIIC melanoma characterized by a BRAFV600E/K mutation. Dabrafenib: Following definitive surgical resection, eligible patients will receive dabrafenib at 150 mg twice a day by mouth for 4 cycles (± 5 days). One cycle is 28 days. |
| 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 | Percentage of Participants With Relapse Free Survival | Relapse free survival is defined as the time from surgical resection to the first recurrence or death as assessed by physical examination and radiographic evaluation. All recurrences will be confirmed by biopsy and histologic evaluation. | 2 participants withdrew consent 1 week after signing consent | Posted | Number | percentage of participants | 24 months |
|
1 year
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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 | Dabrafenib | This is a single institution phase II trial assessing the efficacy of adjuvant dabrafenib (GSK2118436) in patients with surgically resected AJCC stage IIIC melanoma characterized by a BRAFV600E/K mutation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Chapman, MD | Memorial Sloan Kettering Cancer Center | 646-888-4162 | chapmanp@mskcc.org |
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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 | Jun 20, 2018 | Apr 7, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C561627 | dabrafenib |
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| 1 year |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Overall Survival | Overall survival is defined as the time from surgical resection to death or last follow-up. | 2 participants withdrew consent 1 week after signing consent | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years |
|
|
|
| Secondary | Number of Participants With Adverse Events | Toxicity will be graded by the NCI Common Toxicity Criteria (CTC) version 4.0 with each cycle of adjuvant dabrafenib. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 8 |
| 23 |
| 5 |
| 23 |
| 23 |
| 23 |
| Chills | General disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
|
| Neoplasms ben/mal/unk (inccyst/polyp) Other, spec | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Platelet count decreased | Investigations | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
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| White blood cell decreased | Investigations | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Dry Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hand-foot syndrome | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Photosensitivity | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Flushing | Vascular disorders | Systematic Assessment |
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| New primary melanoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Abducens nerve disorder | Nervous system disorders | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Neuropathy | Nervous system disorders | Systematic Assessment |
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| Photophobia | Eye disorders | Systematic Assessment |
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| Blurred vision | Eye disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Leukopenia | Investigations | Systematic Assessment |
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| Transaminitis | Investigations | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |