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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-000725-30 | EudraCT Number |
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The purpose of this study is to see whether a new type of anti-cancer drug, known as BAY 43-9006, can be given safely and with good effect in combination with dacarbazine (DTIC). DTIC is the current standard chemotherapy drug given for melanoma that has spread through the body. Although this drug can be effective on its own and is generally well tolerated, not all patients will benefit, so there is a need to test new drugs and drug combinations for treating melanoma.
Issues on "Safety" outcomes are addressed in the Adverse Event section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorafenib + Dacarbazine | Experimental | Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral sorafenib (Nexavar, BAY 43-9006), 400 mg twice a day (bid) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) + Dacarbazine (DTIC) | Drug | Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral sorafenib (Nexavar, BAY 43-9006), 400 mg twice a day (bid) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Best Response | Best Overall Response (BOR): Best tumor response achieved during or within 30 days after active therapy confirmed according to the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR): The disappearance of all target and non-target lesions. Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD was defined as steady state of disease, PD was defined as an increase of at least 20% increase in the sum of the LD of target lesions or appearance of new lesions. | during or within 30 days after active therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation. | from start of treatment until progression or death before progression (median 259 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux | 33000 | France | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21750549 | Result | Eisen T, Marais R, Affolter A, Lorigan P, Robert C, Corrie P, Ottensmeier C, Chevreau C, Chao D, Nathan PD, Jouary T, Harries M, Negrier S, Montegriffo E, Ahmad T, Gibbens I, James MG, Strauss UP, Prendergast S, Gore ME. Sorafenib and dacarbazine as first-line therapy for advanced melanoma: phase I and open-label phase II studies. Br J Cancer. 2011 Jul 26;105(3):353-9. doi: 10.1038/bjc.2011.257. Epub 2011 Jul 12. |
| Label | URL |
|---|---|
| Click here and search for information of Bayer products for Europe | View source |
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Of the 96 enrolled subjects, 13 were screening failures. The reasons for screening failure were violation of inclusion/exclusion criteria (12) and death due to Progressive Disease (PD) (1). The remaining 83 subjects all received at least one dose of sorafenib and dacarbazine.
This study had a 2-stage Simon optimal design consisting of 30 subjects in the first stage and 52 subjects in the second stage for a planned total of 82 subjects. Actually a total of 96 subjects were enrolled and 83 were treated; 32 in the 1st stage and 51 in the second stage. The study was conducted at 8 centers in the UK and 4 centers in France.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sorafenib + Dacarbazine | Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid), the treatment continued until subjects had clear palliative benefit and were tolerating treatment well, or until progressive disease (PD) or death (if earlier) recorded up to 97 weeks. Subjects withdrawn from Sorafenib but with optional standard treatment entered Active Follow-up (AFU) period, which was 30(+4) days for subjects who had PD at the end of treatment; or until PD was documented for subjects who had complete response (CR) or partial response (PR) or stable disease (SD) at the end of treatment up to 97 weeks . Once subject progressed went into survival only follow-up which continued until death occurred up to 172 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment |
|
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| Percentage of Subjects With Progression-free Survival at Specific Time-points | Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation. | from start of treatment until progression or death before progression after 3, 6 and 12 months |
| Overall Survival | Overall Survival was the number of days from the date that combination treatment started until the date of death. | from start of treatment until death (median 259 days) |
| Duration of Response | Duration of Response was assessed in subjects who showed a Partial Response (PR) or Complete Response (CR). It was defined as the time from the first documented objective response to Progressive Disease (PD), or death if before documented progression. Duration of response for subjects who have not progressed or died at the time of analysis was censored at the date of last tumor assessment. | from confirmed Complete Response (CR) or Partial Response (PR) until Progressive Disease (PD) (median 259 days) |
| Duration of Complete Response | Duration of complete response was the number of days from the date that a complete response was first documented to the date that recurrent or progressive disease was first objectively documented (if patient progressed then censored=no) or to last observation (if patient did not progress then censored=yes). | from confirmed CR until PD (median 259 days) |
| Duration of Partial Response | Duration of partial response was the number of days from the date that a partial response was first documented to the date that recurrent or progressive disease was first objectively documented (if patient progressed then censored=no) or to last observation (if patient did not progress then censored=yes). | from confirmed PR until PD (median 259 days) |
| Disease Control (DC) | DC was defined as the total number of subjects whose best response was not progressive disease (PD) (total number of CRs + total number of PRs + total number of Stable Diseases (SD)). The DC at specific time points could also be calculated as the total number of subjects whose response was not PD at that time point. | after start of treatment, at 6 months and 12 months |
| Duration of Stable Disease | Duration of Stable Disease (DSD), defined as the time from the first documented objective evidence of Stable Disease (SD) to disease progression (DP) or death if death occurred before DP, was assessed in subjects who showed SD as best response. DSD for subjects who had not progressed or died was censored at the date of last tumor assessment. | from start of therapy to PD, only in non-responders (median 259 days) |
| Time to Response | Time to Response in subjects who achieved an objective response (PR or CR with confirmation) was measured from the date of starting study combination treatment until the earliest date that the response was first documented. | start of therapy to confirmed CR or PR (median 259 days) |
| Time to Progression | Time to Progression was the number of days from the start of therapy to progression (if patient progressed then censored=no) or to the last observation at which the patient was known to have not progressed, that is, the last observation with a best response of CR, PR, or SD. | From start of treatment until progression (median 259 days) |
| Lyon |
| 39373 |
| France |
| Toulouse | 31052 | France |
| Villejuif | 94805 | France |
| Cambridge | Cambridgeshire | CB2 0QQ | United Kingdom |
| Southampton | Hampshire | SO16 6YD | United Kingdom |
| London | London | NW3 2QG | United Kingdom |
| London | London | SE1 7EH | United Kingdom |
| London | London | SW3 6JJ | United Kingdom |
| Manchester | Manchester | M20 4BX | United Kingdom |
| Northwood | Middlesex | HA6 2RN | United Kingdom |
| Sutton | Surrey | SM2 5PT | United Kingdom |
| First Stage of Simon Optimal Design |
|
| Second Stage of Simon Optimal Design |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Active Follow-up 30(+4) Days Duration |
|
|
| Survival Only Follow-up |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sorafenib + Dacarbazine | Dacarbazine 1000 mg/m2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Clinical disease status | Clinical disease status at the beginning of the study. Stable Disease (SD): No change in tumor size. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since treatment started, or the appearance of 1 or more new lesions. | Number | participants |
| ||||||||||||||||||||||
| Disease stage (AJCC) | Disease stage according to the American Joint Committee on Cancer (AJCC) based on the TNM (tumor-node-metastasis) classification. Stage I and stage II (T2bN0M0-T4bN0M0) is localized disease, stage III (Any T1-4a, N1bM0-AnyTN3M0) is locally advanced disease and stage IV (Any T, Any N, Any M except M0) is metastatic disease. | Number | participants |
| ||||||||||||||||||||||
| ECOG status | Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects a patient. The scale ranges from 0 (fully active) to 5 (dead). Subjects entering this study must have had an ECOG score of 0 or 1 (restricted in physically strenuous activity but ambulatory). | Number | participants |
| ||||||||||||||||||||||
| Histology | Histologically confirmed melanoma was one of the inclusion criteria for enrollment into the study. This information was collected at the time of enrollment and included in the patient's record. | Number | participants |
| ||||||||||||||||||||||
| Lactate dehydrogenase | Tissue breakdown elevates levels of lactate dehydrogenase (LDH). LDH can be elevated in several disorders, including cancer. | Number | participants |
| ||||||||||||||||||||||
| Mean time from diagnosis | Mean number of days from initial diagnosis to randomization into the study. | Mean | Full Range | days |
|
| 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 | Overall Best Response | Best Overall Response (BOR): Best tumor response achieved during or within 30 days after active therapy confirmed according to the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR): The disappearance of all target and non-target lesions. Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD was defined as steady state of disease, PD was defined as an increase of at least 20% increase in the sum of the LD of target lesions or appearance of new lesions. | There were 83 subjects in the intent-to-treat (ITT) population. Of these, 75 were evaluable for Best Response; 8 were not evaluable. | Posted | Number | participants | during or within 30 days after active therapy |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation. | There were 83 subjects in the intent-to-treat (ITT) population. All 83 were included in this analysis. | Posted | Median | 95% Confidence Interval | days | from start of treatment until progression or death before progression (median 259 days) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Progression-free Survival at Specific Time-points | Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation. | There were 83 subjects in the intent-to-treat (ITT) population. All 83 were included in this analysis. | Posted | Number | percentage of participants | from start of treatment until progression or death before progression after 3, 6 and 12 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall Survival was the number of days from the date that combination treatment started until the date of death. | There were 83 subjects in the intent-to-treat (ITT) population. All 83 were included in this analysis. | Posted | Median | 95% Confidence Interval | days | from start of treatment until death (median 259 days) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of Response was assessed in subjects who showed a Partial Response (PR) or Complete Response (CR). It was defined as the time from the first documented objective response to Progressive Disease (PD), or death if before documented progression. Duration of response for subjects who have not progressed or died at the time of analysis was censored at the date of last tumor assessment. | There were 83 subjects in the intent-to-treat (ITT) population. Only the 10 subjects who had a PR or CR were included in this analysis. | Posted | Median | Full Range | days | from confirmed Complete Response (CR) or Partial Response (PR) until Progressive Disease (PD) (median 259 days) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Complete Response | Duration of complete response was the number of days from the date that a complete response was first documented to the date that recurrent or progressive disease was first objectively documented (if patient progressed then censored=no) or to last observation (if patient did not progress then censored=yes). | There were 83 subjects in the intent-to-treat (ITT) population. Only the 1 subject who had a CR was included in this analysis (duration 420 days, censored). | Posted | Number | days | from confirmed CR until PD (median 259 days) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Partial Response | Duration of partial response was the number of days from the date that a partial response was first documented to the date that recurrent or progressive disease was first objectively documented (if patient progressed then censored=no) or to last observation (if patient did not progress then censored=yes). | There were 83 subjects in the intent-to-treat (ITT) population. Only the 9 subjects who had a PR were included in this analysis. | Posted | Median | 95% Confidence Interval | days | from confirmed PR until PD (median 259 days) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control (DC) | DC was defined as the total number of subjects whose best response was not progressive disease (PD) (total number of CRs + total number of PRs + total number of Stable Diseases (SD)). The DC at specific time points could also be calculated as the total number of subjects whose response was not PD at that time point. | There were 83 subjects in the intent-to-treat (ITT) population. All 83 were included in this analysis. | Posted | Number | participants | after start of treatment, at 6 months and 12 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Stable Disease | Duration of Stable Disease (DSD), defined as the time from the first documented objective evidence of Stable Disease (SD) to disease progression (DP) or death if death occurred before DP, was assessed in subjects who showed SD as best response. DSD for subjects who had not progressed or died was censored at the date of last tumor assessment. | There were 83 subjects in the intent-to-treat (ITT) population. Only the 70 subjects who had a Best Response of Stable Disease, ie, those who failed to achieve a Best Response of CR or PR, were included in this analysis. | Posted | Median | 95% Confidence Interval | days | from start of therapy to PD, only in non-responders (median 259 days) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response | Time to Response in subjects who achieved an objective response (PR or CR with confirmation) was measured from the date of starting study combination treatment until the earliest date that the response was first documented. | There were 83 subjects in the intent-to-treat (ITT) population. Only the 10 subjects who had a PR or CR were included in this analysis. | Posted | Median | 95% Confidence Interval | days | start of therapy to confirmed CR or PR (median 259 days) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression | Time to Progression was the number of days from the start of therapy to progression (if patient progressed then censored=no) or to the last observation at which the patient was known to have not progressed, that is, the last observation with a best response of CR, PR, or SD. | There were 83 subjects in the intent-to-treat (ITT) population. Of these 83, 78 were included in this analysis. | Posted | Median | 95% Confidence Interval | days | From start of treatment until progression (median 259 days) |
|
|
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The following abbreviations were used in the Adverse Event section: - Q-T Corrected (QTc) - Common Terminology Criteria for Adverse Events (CTCAE) - Not Otherwise Specified (NOS) - Gastrointestinal (GI) - Alanine aminotransferase (ALT)
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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 | Sorafenib + Dacarbazine | Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid) | 40 | 83 | 82 | 83 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood - other | Blood and lymphatic system disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Leukocytes | Blood and lymphatic system disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Neutrophile | Blood and lymphatic system disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Cardiac arrhythmia - other | Cardiac disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Prolonged QTC | Cardiac disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Supraventricular arrhythmia, atrial fibrillation | Cardiac disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Cardiac ischemia/infarction | Cardiac disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Fever | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Death not associated with CTAE term, disease progression nos | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Dermatology - other | Skin and subcutaneous tissue disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hemorrhage - other | Vascular disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hemorrhage, GI, lower GI | Vascular disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hemorrhage, GI, upper GI nos | Vascular disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Hepathobiliary - other | Hepatobiliary disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Liver dysfunction | Hepatobiliary disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Infection (doc. clinic), foreign body (e.g. graft, implant, pros, stent) | Infections and infestations | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Infection (documented clinically), lung (pneumonia) | Infections and infestations | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Infection (documented clinically), upper airway nos | Infections and infestations | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Infection - other | Infections and infestations | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Device/prosthesis | Musculoskeletal and connective tissue disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Musculoskeletal - other | Musculoskeletal and connective tissue disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Confusion | Nervous system disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Neurology - other | Nervous system disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Ocular - other | Eye disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pain, abdomen nos | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pain, chest/thorax nos | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pain, head/headache | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pain, other | General disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Renal - other | Renal and urinary disorders | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Secondary malignancy (possibly related to cancer treatment) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI CTC v.3.0 | Non-systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | NCI CTC v.3.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophils | Blood and lymphatic system disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Leukocytes | Blood and lymphatic system disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Cardiac arrhythmia - other | Cardiac disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Fever | General disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Constitutional symptoms - other | General disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Sweating | General disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Heartburn | Gastrointestinal disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Mucositis (functional/symptomatic), oral cavity | Gastrointestinal disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Mucositis (clinical exam), oral cavity | Gastrointestinal disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Infection - other | Infections and infestations | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| ALT | Metabolism and nutrition disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Amylase | Metabolism and nutrition disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Metabolic/lab - other | Metabolism and nutrition disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Mood alteration, depression | Nervous system disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Neurology - other | Nervous system disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Neuropathy: Sensory | Nervous system disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Pain, back | General disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Pain, chest/thorax nos | General disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Pain, extremity-limb | General disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Pain, abdomen nos | General disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Pain, head/headache | General disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Pain, joint | General disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Pain, other | General disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Pain, pelvis | General disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Voice changes | Respiratory, thoracic and mediastinal disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Hand-foot skin reaction | Skin and subcutaneous tissue disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Dermatology - other | Skin and subcutaneous tissue disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
| |
| Flushing | Skin and subcutaneous tissue disorders | NCI CTC v. 3.0 | Non-systematic Assessment |
|
Due to the small number of patients, no conclusions can be drawn from these data in terms of BRAF mutations.
Publication will be discussed with the sponsor prior to release and written consent of the sponsor will be obtained. A draft manuscript of the publication or abstract must be sent to sponsor thirty days in advance of submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| D003606 | Dacarbazine |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
Not provided
Not provided
| Progressive disease |
|
| M1b Lung metastases |
|
| M1c All other visceral metastases |
|
| 1 |
|
| Superfical spreading |
|
| Nodular |
|
| Acral lentiginous |
|
| >= ULN but < 10 percent above ULN |
|
| >= 10 percent above the ULN |
|
| Title | Measurements |
|---|---|
|
| Stable disease (SD) |
|
| Progressive disease (PD) |
|
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