Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-00469 | Registry Identifier | NCI CTRP |
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Unanticipated Toxicities
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Phase I Objectives:
-To determine the maximum tolerated dose (MTD) of vorinostat + erlotinib versus vorinostat + erlotinib + temozolomide in adult patients with recurrent glioblastoma multiforme (GBM) and anaplastic gliomas.
Phase II Objectives:
Primary: To determine the efficacy of vorinostat + erlotinib versus vorinostat + erlotinib + temozolomide in patients with recurrent glioblastoma multiforme as progression free survival using a two arm adaptive randomization phase II trial design.
Secondary: To determine the radiological response, progression free survival (PFS) at 6 months, overall survival and unexpected toxicity in the two treatment arms; and to obtain exploratory data regarding histone 3 and 4 acetylation, treatment related changes in the epidermal growth factor receptor (EGFR) pathway proteins, and changes in e-cadherin and vimentin expression (mRNA /protein) levels in tumor tissue and peripheral monocytes in a subset of surgical patients.
Phase I:
The Study Drugs:
Vorinostat is designed to cause chemical changes in different groups of proteins that are attached to DNA (the genetic material of cells), which may slow the growth of cancer cells or cause the cancer cells to die.
Erlotinib is designed to block the activity of a protein found on the surface of many tumor cells that may control tumor growth and survival. This may stop tumors from growing.
Temozolomide is designed to kill cancer cells by damaging DNA (the genetic material of cells). The damaged DNA may cause tumor cell death.
Study Groups:
There are 2 phases to this study.
If you are found to be eligible to take part in the Phase I portion of this study, you will be assigned to 1 of 2 groups based on when you join this study. You will remain in the same group for the entire study. In this study, the dose level of the study drugs is different from group to group. Up to 4 dose levels of study drug combinations will be tested in Group 1, up to 2 dose levels in Group 2. Three (3) participants will be enrolled at each dose level. The first 3 participants in each group will receive the lowest dose level. Each 3 new participants will receive a higher dose than the one before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of study drugs given in combination is found.
In addition, no matter which group or dose level you are assigned to, if you are on enzyme inducing anti-seizure drug, you will take a higher dose of erlotinib.
Study Drug Administration:
Each study cycle is 28 days.
If you are in Group 1:
If you are in Group 2:
Study Visits:
Every 4 weeks for the first 8 weeks, then every 8 weeks after that:
Every week for the first 4 weeks, then every 2 weeks after that, blood (about 3 teaspoons) will be drawn for routine tests and to check your blood's ability to clot normally.
Every 4 weeks, if you are on anti-seizure drugs, blood (about 1 teaspoon) will be drawn to measure the amount of anti-seizure drugs in your blood.
Every 8 weeks, you will have an MRI scan to check the status of the disease.
Length of Study:
You will be on study for up to 1 year. You may continue to receive the study drugs beyond 1 year and remain on study if your doctor decides that it is in your best interest. You will be taken off study early if the disease gets worse or you experience intolerable side effects.
Long-Term Follow-Up Visit:
If you go off study after 12 cycles, blood (about 3 teaspoons) will be drawn for routine tests and to check your blood's ability to clot normally every 2 weeks during the 30 days after your last dose of study drugs.
If you go off the study for reasons other than the worsening of the disease, you will have an MRI every 2 months unless the disease gets worse.
If you have an MRI that shows worsening of the disease, every 2-3 months from then on, you may be called and asked how you are feeling and about any new cancer treatment that you may have received. This phone call should take about 5-10 minutes.
This is an investigational study. Erlotinib is FDA approved drug for treatment of some types of non-small cell lung cancer, temozolomide for some types of brain cancer, and vorinostat for some types of lymphoma. All are commercially available. The use of these drugs in this combination is investigational.
Up to 182 participants will take part in this study. Up to 72 patients will be enroll in the Phase 1 portion of this study. All will be enrolled at MD Anderson.
Phase II:
The Study Drugs:
Vorinostat is designed to cause chemical changes in different groups of proteins that are attached to DNA (the genetic material of cells), which may slow the growth of cancer cells or cause the cancer cells to die.
Erlotinib is designed to block the activity of a protein found on the surface of many tumor cells that may control tumor growth and survival. This may stop tumors from growing.
Temozolomide is designed to kill cancer cells by damaging DNA (the genetic material of cells). The damaged DNA may cause tumor cell death.
Study Groups:
There are 2 phases to this study.
If you are found to be eligible to take part in the Phase 2 portion of this study, you will be randomly assigned (as in the roll of the dice) to 1 of 2 groups.
Subset Group:
If your doctor has recommended that you have surgery to remove a tumor that has come back, you will be eligible for this subset group. You would have the surgery before being assigned to a main study group. This subset group of the study is done to learn the effects of vorinostat on tumor tissue and blood cells.
Before surgery, you will be randomly assigned to 1 of 3 groups.
You will take the study drug(s) for 3 days in a row before your surgery.
About 2 weeks after the surgery, you will be randomly assigned to 1 of 2 main study groups described above (Group 1 or 2).
In addition, no matter which group you are assigned to, if you are on enzyme inducing anti-seizure drug, you will take the higher dose of erlotinib.
Study Drug Administration:
Every cycle is 28 days.
If you are in Group 1:
If you are in Group 2:
Subset group:
For 3 days in row before surgery:
After you have recovered from the effects of surgery (about 2 weeks), you will follow the study group schedule (Group 1 or 2) described above.
Study Visits:
Every 4 weeks for the first 8 weeks, then every 8 weeks after that:
Every week for the first 4 weeks, then every 2 weeks after that, blood (about 3 teaspoons) will be drawn for routine tests and to check your blood's ability to clot normally.
Every 4 weeks, if you are on anti-seizure medications, blood (about 1 teaspoon) will be drawn to measure the amount of anti-seizure medications in your blood.
Every 8 weeks, you will have an MRI scan to check the status of the disease.
Subset Group:
In addition to the above tests, blood (about 1 teaspoon each time) will be drawn 1 time before and 3 times after the first dose of vorinostat, and during surgery. This blood will be used to study the drug levels, the effects of the drug in normal blood cells, and to match these findings with that in the tumor.
After the surgery, part of the leftover tumor tissue from the surgery will be used to measure the drug levels and the effects of vorinostat on the tumor and be used for biomarker tests.
Length of Study:
You will be on study for up to 1 year. You may continue to receive treatment beyond 1 year and remain on study if your doctor decides that it is in your best interest. You will be taken off study early if the disease gets worse or you have intolerable side effects.
Long-Term Follow-Up Visit:
If you go off study after 12 cycles, blood (about 3 teaspoons) will be drawn for routine tests and to check your blood's ability to clot normally every 2 weeks during the 30 days after your last dose of study drugs.
If you go off the study for reasons other than the worsening of the disease, you will have an MRI every 2 months unless the disease gets worse.
If you have an MRI that shows worsening of the disease, every 2-3 months from then on, you may be called and asked how you are feeling and about any new cancer treatment that you may have received. This phone call will take about 5-10 minutes.
This is an investigational study. Erlotinib is FDA approved drug for treatment of some types of non-small cell lung cancer, temozolomide for some types of brain cancer, and vorinostat for some types of lymphoma. All are commercially available. The use of these drugs in this combination is investigational.
Up to 182 participants will take part in this study. Up to 110 patients will be enrolled in the Phase 2 portion of this study. Up to 15 participants will take part in the subset portion of the study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I Group 1: Vorinostat + Erlotinib + Temozolomide | Experimental | Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide Starting doses Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 125 mg/m^2 orally once daily on Days 1-7 and 15-21. |
|
| Phase I Group 2: Vorinostat + Erlotinib | Experimental | This Phase I arm to be activated only after completion of Part A of the Phase II trial of the 3-Drug combination. If part A of the Phase II trial shows lack of efficacy, trial will be terminated. Vorinostat orally twice daily, Days 1-14; and Erlotinib orally once daily Days 1-21 of every cycle. |
|
| Phase II Part A 3-Drug Combination | Experimental | Vorinostat+Erlotinib+Temozolomide where drug dosing based on the MTD identified in the Phase I portion of the study. Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 100 mg/m^2 orally once daily on Days 1-7 and 15-21. |
|
| Phase II Part B 2-Drug Combination | Experimental | This Phase II Part B arm to be activated only after completion of Part A of the Phase I and II Part A trial of the 3-Drug combination. If part A of the Phase II trial shows lack of efficacy, trial will be terminated. Vorinostat orally twice daily, Days 1-14; and Erlotinib orally once daily Days 1-21 of every cycle. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vorinostat | Drug | Phase I Starting Dose: 200 mg twice daily by mouth on Days 1-7, 15-21 of each 28 day cycle. Phase II Dose: MTD from Phase I. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Vorinostat in Combination With Escalating Doses of Erlotinib and Temozolomide | Phase I assessment MTD Vorinostat in combination with escalating doses of Erlotinib and Temozolomide using conventional phase I design where 3 enrolled into first dose level, monitored for 3 weeks and if no dose-limiting toxicity (DLT) seen, 3 more enrolled at next dosage level. If 2/6 participants experience DLT, the previous (lower) dosage level declared MTD of vorinostat in combination with Erlotinib and Temozolomide. A maximum of 4 dosage levels utilized with deescalation by 2 dose levels if DLT is seen at the starting dose level. If no DLT noted after dose escalation to Level 4, these doses utilized as MTD for phase II. | Evaluated with each 28 day (+2 days) cycle, up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | This is an adaptive randomized phase II trial to Vorinostat + Erlotinib to Vorinostat + Erlotinib + Temozolomide in patients with recurrent GBM. The primary outcome is progression free survival (PFS). Patients will be randomized between the two arms using a Bayesian adaptive algorithm. Participants randomized equally between the two arms at the start of the trial (for the first 20 patients). Thereafter, as the trial progresses and data accrue, the randomization will become unbalanced in favor of the treatment that, on average, has better results in terms of failure time. Therefore, each successive patient is more likely to receive the treatment with better results, on average. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John DeGroot, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
Not provided
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
Not provided
Of the 14 participants registered in Phase I, two participants did not begin study due to financial reasons and were excluded. One of the six participants in Phase II one was not eligible and is also excluded. The study did not progress to the next stage of Phase II with adaptive randomized arms.
Recruitment Period: June 21, 2011 to March 18, 2013. All recruitment done at The University of Texas MD Anderson Cancer Center.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Phase I: Vorinostat + Erlotinib + Temozolomide | Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide Starting doses Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 125 mg/m^2 orally once daily on Days 1-7 and 15-21. |
| FG001 | Phase II Part A 3-Drug Combination | Vorinostat+Erlotinib+Temozolomide where drug dosing based on the MTD identified in the Phase I portion of the study. Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 100 mg/m^2 orally once daily on Days 1-7 and 15-21. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase I Group 1: Vorinostat + Erlotinib + Temozolomide | Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide Starting doses Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 125 mg/m2 orally once daily on Days 1-7 and 15-21. |
| BG001 |
| 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 |
| 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 (MTD) of Vorinostat in Combination With Escalating Doses of Erlotinib and Temozolomide | Phase I assessment MTD Vorinostat in combination with escalating doses of Erlotinib and Temozolomide using conventional phase I design where 3 enrolled into first dose level, monitored for 3 weeks and if no dose-limiting toxicity (DLT) seen, 3 more enrolled at next dosage level. If 2/6 participants experience DLT, the previous (lower) dosage level declared MTD of vorinostat in combination with Erlotinib and Temozolomide. A maximum of 4 dosage levels utilized with deescalation by 2 dose levels if DLT is seen at the starting dose level. If no DLT noted after dose escalation to Level 4, these doses utilized as MTD for phase II. | One participant started later than 12 assigned to original MTD dose levels, and was excluded from this analysis. | Posted | Number | mg | Evaluated with each 28 day (+2 days) cycle, up to 24 weeks |
|
Adverse event collection events that occurred after participants received study drug through a treatment cycle of 28 days (+3 days) and within 30 days of last treatment dose.
Due to effect enzyme inducing anticonvulsants (EIACs) on erlotinib, 2 different Phase I dosing schedules (participants on EIACs or those on non-enzyme inducing antiepileptics (NEIACs) were used. AEs reported separately. Participants experiencing different adverse events with different grade are counted only once at highest grade experienced.
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 | Phase I Dose 0: Vorinostat 200 mg + Temozolomide 125 mg/m^2 | Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 125 mg/m^2 orally once daily on Days 1-7 and 15-21. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | CTCAE (2.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACNE | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John de Groot, MD/Associate Professor, NEURO-ONCOLOGY | University of Texas (UT) MD Anderson Cancer Center | (713) 745-3072 | jdegroot@mdanderson.org |
Not provided
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D005909 | Glioblastoma |
| D005910 | Glioma |
| D018316 | Gliosarcoma |
| D001254 | Astrocytoma |
| D009837 | Oligodendroglioma |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077337 | Vorinostat |
| D000069347 | Erlotinib Hydrochloride |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Erlotinib | Drug | Phase I Starting Dose: 200 mg by mouth daily on Days 1-21 of 28 day cycle. For patients on enzyme inducing anticonvulsants (EIACs), starting dose of 400 mg. Phase II Dose: MTD from Phase I. |
|
|
| Temozolomide | Drug | 125 mg/m2 by mouth daily on days 1-7, 15-21 of each 28 day cycle. |
|
|
| 6 months |
| Phase II Part A 3-Drug Combination |
Vorinostat+Erlotinib+Temozolomide where drug dosing based on the MTD identified in the Phase I portion of the study. Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 100 mg/m2 orally once daily on Days 1-7 and 15-21. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Enzyme Inducing Anti-Convulsants (EIACs) | Count of Participants | Participants |
|
Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide Starting doses Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 125 mg/m^2 orally once daily on Days 1-7 and 15-21. |
|
|
| Secondary | Progression Free Survival (PFS) | This is an adaptive randomized phase II trial to Vorinostat + Erlotinib to Vorinostat + Erlotinib + Temozolomide in patients with recurrent GBM. The primary outcome is progression free survival (PFS). Patients will be randomized between the two arms using a Bayesian adaptive algorithm. Participants randomized equally between the two arms at the start of the trial (for the first 20 patients). Thereafter, as the trial progresses and data accrue, the randomization will become unbalanced in favor of the treatment that, on average, has better results in terms of failure time. Therefore, each successive patient is more likely to receive the treatment with better results, on average. | No data collected. The study did not progress to the next stage of Phase II with adaptive randomized arms. | Posted | 6 months |
|
|
| 3 |
| 6 |
| 6 |
| 6 |
| EG001 | Phase I Dose -1: Vorinostat 200 mg + Temozolomide 100 mg/m^2 | Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg twice daily on Days 1-21; Temozolomide 100 mg/m^2 orally once daily on Days 1-7 and 15-21. | 4 | 6 | 6 | 6 |
| EG002 | Phase I EIACs: Vorinostat 400 mg + Temozolomide 125 mg/m^2 | Phase I 3-Drug Combination Vorinostat with Erlotinib + Temozolomide for participant on enzyme inducing anticonvulsants (EIACs): Vorinostat 400 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 100 mg orally once daily on Days 1-21; Temozolomide 125 mg/m^2 orally once daily on Days 1-7 and 15-21. | 0 | 1 | 1 | 1 |
| EG003 | Phase II 3-Drug Combination | Vorinostat+Erlotinib+Temozolomide where drug dosing based on the MTD identified in the Phase I portion of the study. Vorinostat 200 mg orally twice daily on Days 1-7 and 15-21 of every cycle; Erlotinib 200 mg orally once daily on Days 1-21; Temozolomide 100 mg/m^2 orally once daily on Days 1-7 and 15-21. | 1 | 5 | 5 | 5 |
| BILIRUBIN | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Central Nervous System (CNS) ISCHEMIA | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| DEHYDRATION | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| DIARRHEA | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| FATIGUE | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| HYPONATREMIA | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| INFECTION CLINICAL | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| MENTAL STATUS | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| MUSCLE WEAKNESS | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| PLATELETS, DECREASE | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| SEIZURE | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| THROMBOSIS/THROMBUS/EMBOLISM | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Neurological Disorder | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| ALKALINE PHOSPHATASE | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| ALLERGIC RHINITIS | Immune system disorders | CTCAE (2.0) | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| ALT SGPT | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| ANOREXIA | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| AST SGOT | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| BICARBONATE SERUM-LOW | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| BILIRUBIN | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| BLURRED VISION | Eye disorders | CTCAE (2.0) | Systematic Assessment |
|
| CNS ISCHEMIA | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| COGNITIVE DISTURBANCE | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| CONFUSION | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| CREATININE | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| DECUBITUS ULCER | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| DEHYDRATION | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| DIARRHEA | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| DRY MOUTH | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| DYSPHAGIA | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| FATIGUE | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| FEVER WITHOUT NEUTROPENIA | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| GAIT/WALKING | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| HEARING (W/O MONITORING) | Ear and labyrinth disorders | CTCAE (2.0) | Systematic Assessment |
|
| HEARTBURN | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| HEMOGLOBIN | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| HEMORRHAGE GU (KIDNEY) | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| HEMORRHAGE PULMONARY (NOSE) | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| HEMORRHOIDS | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| HICCOUGHS | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| HYPERCALCAEMIA | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| HYPERGLYCEMIA | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| HYPERMAGNESEMIA | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| HYPERTENSION | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| HYPOALBUMINEMIA | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| HYPOCALCEMIA | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| HYPOGLYCEMIA | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| HYPOKALEMIA | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| HYPOMAGNESEMIA | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| HYPONATREMIA | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| HYPOPHOSPHATEMIA | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| INCONTINENCE URINARY | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| INFECTION CLINICAL + GRADE 3-4 ANC (URINARY TRACT NOS) | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| INFECTION UNKNOWN ANC (URINARY TRACT NOS) | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| INFECTION W NORMAL ANC (UPPER AIRWAY NOS) | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| INFECTION W NORMAL ANC (URINARY TRACT NOS) | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| INFECTION W NORMAL ANC(BLOOD SEPSIS) | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| INSOMNIA | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| LEUKOCYTES | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| LIPASE INCREASED | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| LYMPHOPENIA | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| MEMORY IMPAIRMENT | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| MENTAL STATUS | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| METABOLIC/LABORATORY (OTHER) | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| MOOD ALTERATION (DEPRESSION) | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| MUCOSITIS (SYMPTOMATIC) ORAL CAVITY | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| MUSCLE WEAKNESS (LEFT-SIDED) | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| MUSCLE WEAKNESS (WHOLE BODY/GENERALIZED) | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| MUSCULOSKELETAL (OTHER) | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| NASAL/PARANASAL REACTIONS | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| NEUROLOGY (OTHER) | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| NEUTROPHILS (ANC/AGC) | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| OCULAR/VISUAL (OTHER) | Eye disorders | CTCAE (2.0) | Systematic Assessment |
|
| PAIN (ABDOMEN NOS) | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| PAIN (BACK) | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| PAIN (CHEST/THORAX) | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| PAIN (EXTREMITY-LIMB) | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| PAIN (HEAD/HEADACHE) | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| PAIN (MUSCLE) | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| PAIN (ORAL CAVITY) | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| PAIN (OTHER) | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| PAIN (THROAT/PHARYNX/LARYNX) | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| PALPITATIONS | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| PETECHIAE | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| PLATELETS | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| PSYCHOSIS | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| PYRAMIDAL TRACT DYSFUNCTION | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| RASH/DESQUAMATION | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| RIGORS/CHILLS | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| SEIZURE | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| SOMNOLENCE | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| SPEECH IMPAIRMENT | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| SYNCOPE (FAINTING) | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| TASTE ALTERATION | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| THROMBOSIS/THROMBUS/EMBOLISM | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| TREMOR | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| URINARY FREQUENCY | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| URINE COLOR CHANGE | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| VOICE CHANGES | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| WEIGHT LOSS | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| BRUISING (NO THROMBOPENIA) | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| CUSHINGOID | Endocrine disorders | CTCAE (2.0) | Systematic Assessment |
|
| DIPLOPIA | Eye disorders | CTCAE (2.0) | Systematic Assessment |
|
| EDEMA: LIMB | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| HYPOPIGMENTATION | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| HYPOTENSION | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| INFECTION UNKNOWN ANC (UPPER AIRWAY NOS) | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| INFECTION W NORMAL ANC (CONJUNCTIVA) | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D000588 |
| Amines |
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |