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| ID | Type | Description | Link |
|---|---|---|---|
| U01CA137443 | U.S. NIH Grant/Contract | View source | |
| ABTC-0901 | |||
| IMCL-CP-19-0801 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Eli Lilly and Company | INDUSTRY |
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RATIONALE: Monoclonal antibodies, such as ramucirumab and anti-PDGFR alpha monoclonal antibody IMC-3G3 (Olaratumab), can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase II trial is studying how well ramucirumab or anti-PDGFR alpha monoclonal antibody IMC-3G3 works in treating patients with recurrent glioblastoma multiforme.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are sequentially assigned to 1 of 2 treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Patients receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. |
|
| Group 2 | Experimental | Patients receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olaratumab | Biological | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Progression-Free Survival Rate at 6 Months (PFS-6) | PFS was defined as the start of treatment to the earliest date of tumor progression or death from any cause based on the modified Response Assessment in Neuro-Oncology Group through the American Society of Clinical Oncology (RANO) criteria. Progression is defined by any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. RANO is a standardized response criteria using bi-dimensional measurements of the largest contrast-enhancing area (Macdonald, 1990). | Start of treatment to PD or Death Up To 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events as Assessed by NCI CTCAE v4.0 (National Cancer Institute-Common Terminology Criteria for Adverse Events) | The number of participants who experienced serious adverse events (SAEs) that were considered to be related to ramucirumab or olaratumab. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed supratentorial glioblastoma multiforme (GBM)
Progressive or recurrent disease after radiotherapy ± chemotherapy
Measurable disease by contrast-enhanced MRI or CT scan
PATIENT CHARACTERISTICS:
Karnofsky performance status 60-100%
Life expectancy ≥ 3 months
Absolute neutrophil count ≥ 1,500/millimeter cubed (mm³)
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9 gram/deciliter (g/dL)
Creatinine ≤ 1.5 milligram/deciliter (mg/dL) OR creatinine clearance > 60 mL/min
Total bilirubin ≤ 1.5 mg/dL
Transaminases ≤ 3 times upper limit of normal (ULN)
Urine protein ≤ 2+ by dipstick or urinalysis or ≤ 1,000 mg by 24-hour urine collection
International Normalized Ratio (INR) ≤ 1.5
Partial Thromboplastin Time (PTT) ≤ 5 seconds above ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for ≥ 12 weeks after completion of study treatment
Mini Mental State Exam score ≥ 15
Able to undergo magnetic resonance imaging (MRI) (i.e., no pacemaker, aneurysm clip, or claustrophobia)
No concurrent serious infection or medical illness that would jeopardize the ability of the patient to receive the treatment outlined in this study with reasonable safety including, but not limited to, any of the following:
No other malignancy within the past 5 years, except curatively treated carcinoma in situ or basal cell carcinoma of the skin
No major bleeding episode within the past 3 months
No myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack within the past 6 months
No serious or non-healing wound, ulcer, or bone fracture
No uncontrolled or poorly controlled hypertension, despite standard medical management
No known allergy to any of the treatment components
No known HIV positivity or AIDS-related illness
No uncontrolled thrombotic or hemorrhagic disorders
No grade 3-4 gastrointestinal bleeding within the past 3 months
No gross hemoptysis (≥ ½ teaspoon) within the past 2 months
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Recovered from prior therapy
At least 3 months since prior radiotherapy
At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
At least 2 weeks since prior FDA-approved, non-cytotoxic agents (e.g., celecoxib, thalidomide)
At least 3 weeks since prior investigational, non-cytotoxic agents
More than 28 days since prior major surgery, including brain biopsy
More than 7 days since prior subcutaneous venous access device placement
No prior treatment with other agents that directly inhibit Platelet-Derived Growth Factor Receptor (PDGFR)α/β, Platelet-Derived Growth Factor (PDGF), Vascular Endothelial Growth Factor (VEGF), or Vascular Endothelial Growth Factor Receptor (VEGFR)s
No concurrent therapeutic anticoagulation, chronic daily treatment with aspirin (> 325 mg/day), or other known inhibitors of platelet function
No concurrent prophylactic hematopoietic growth factors (e.g., erythropoietin, Granulocyte Colony Stimulating Factor (G-CSF), Granulocyte-macrophage Colony Stimulating Factor (GM-CSF), or Interleukin (IL-11) during the first course of treatment
No concurrent elective or planned surgery
No other concurrent therapy for the tumor (e.g., chemotherapy or investigational agents)
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| Name | Affiliation | Role |
|---|---|---|
| Jaishri O. Blakeley, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Comprehensive Cancer Center | Birmingham | Alabama | 35294-3410 | United States | ||
| Jonsson Comprehensive Cancer Center at UCLA |
The completers include those participants with progressive disease (PD) or those who died.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 Ramucirumab | Participants receive ramucirumab intravenously (IV) over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. |
| FG001 | Group 2 Olaratumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ramucirumab | Biological | Given IV |
|
| Start of Treatment to End of Study (Up to 13 Months) |
| Percentage of Participants (Pts) With Complete Response (CR), Partial Response (PR) and Minor Response (MR) (Objective Response Rate [ORR]) | The pts achievement of both measurement and confirmation criteria for a status of CR, PR or MR based on the modified RANO criteria.CR requires all of the following:complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks (wks);no new lesions;no corticosteroids;and stable or improved clinically.PR requires all of the following:≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 wks;no new lesions;stable or reduced corticosteroid dose;and stable or improved clinically.MR requires ≥ 25% reduction in sum of products of the perpendicular diameters of all measureable enhancing lesions sustained for at least 4 wks and no new lesions or progression of non-measurable lesions. PD is defined by any of these: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions;any new lesion;or clinical deterioration. | Start of Treatment to PD Up To 20 Months |
| Median Overall Survival (OS) | OS is the time from the start of treatment to the date of death. Participants who had not expired by the data analysis cutoff date were censored at their last date known to be alive. | Start of Treatment to Death Up To 27 Months |
| Pharmacokinetics (PK): Concentration Maximum (Cmax) and Concentration Minimum (Cmin) of Ramucirumab | Cycle 7, Day 1: Prior to Infusion,1 hour (hr) Post Infusion |
| PK: Cmax and Cmin of Olaratumab | Cycle 3, Day 1: Prior to Infusion, 1 hr Post Infusion |
| Pharmacodynamics (PD) Profiles | Cycle 7, Day 1: Prior to Infusion, 1 hr Post Infusion |
| Percentage of Participants With Anti-Olaratumab Antibodies (ADA) | Percentage of Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20. | Start of Treatment to 30-day Post Infusion Follow Up (Up to 6 Months) |
| Percentage of Participants With Anti-Ramucirumab Antibodies (ADA) | Percentage of Participants with Treatment Emergent (TE) anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20. | Start of Treatment to 30-day Post Infusion Follow Up (Up to 6 Months) |
| Los Angeles |
| California |
| 90095 |
| United States |
| University of California San Francisco Medical Center | San Francisco | California | 94143 | United States |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa | Florida | 33612-9497 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| University of Pittsburgh School of Medicine | Pittsburgh | Pennsylvania | 15232 | United States |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin | 53792 | United States |
Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 Ramucirumab | Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. |
| BG001 | Group 2 Olaratumab | Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. |
| 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 | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Percentage of Participants Who Achieved Progression-Free Survival Rate at 6 Months (PFS-6) | PFS was defined as the start of treatment to the earliest date of tumor progression or death from any cause based on the modified Response Assessment in Neuro-Oncology Group through the American Society of Clinical Oncology (RANO) criteria. Progression is defined by any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. RANO is a standardized response criteria using bi-dimensional measurements of the largest contrast-enhancing area (Macdonald, 1990). | All enrolled participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Start of treatment to PD or Death Up To 6 Months |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events as Assessed by NCI CTCAE v4.0 (National Cancer Institute-Common Terminology Criteria for Adverse Events) | The number of participants who experienced serious adverse events (SAEs) that were considered to be related to ramucirumab or olaratumab. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. | All enrolled participants who received at least one dose of study drug. | Posted | Number | participants | Start of Treatment to End of Study (Up to 13 Months) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants (Pts) With Complete Response (CR), Partial Response (PR) and Minor Response (MR) (Objective Response Rate [ORR]) | The pts achievement of both measurement and confirmation criteria for a status of CR, PR or MR based on the modified RANO criteria.CR requires all of the following:complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks (wks);no new lesions;no corticosteroids;and stable or improved clinically.PR requires all of the following:≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 wks;no new lesions;stable or reduced corticosteroid dose;and stable or improved clinically.MR requires ≥ 25% reduction in sum of products of the perpendicular diameters of all measureable enhancing lesions sustained for at least 4 wks and no new lesions or progression of non-measurable lesions. PD is defined by any of these: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions;any new lesion;or clinical deterioration. | All enrolled participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Start of Treatment to PD Up To 20 Months |
| |||||||||||||||||||||||||||||||
| Secondary | Median Overall Survival (OS) | OS is the time from the start of treatment to the date of death. Participants who had not expired by the data analysis cutoff date were censored at their last date known to be alive. | All enrolled participants who received at least one dose of study drug. Participants censored in ramucirumab = 4 and olaratumab = 4. | Posted | Median | 95% Confidence Interval | Weeks | Start of Treatment to Death Up To 27 Months |
|
| |||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK): Concentration Maximum (Cmax) and Concentration Minimum (Cmin) of Ramucirumab | All enrolled participants who received at least one dose of ramucirumab and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram/milliliter (μg/mL) | Cycle 7, Day 1: Prior to Infusion,1 hour (hr) Post Infusion |
|
| ||||||||||||||||||||||||||||||
| Secondary | PK: Cmax and Cmin of Olaratumab | All enrolled participants who received at least one dose of Olaratumab and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Cycle 3, Day 1: Prior to Infusion, 1 hr Post Infusion |
|
| ||||||||||||||||||||||||||||||
| Secondary | Pharmacodynamics (PD) Profiles | Zero participants were analyzed for pharmacodynamic profile as the plasma collection procedure in this study was not fit for this purpose. | Posted | Cycle 7, Day 1: Prior to Infusion, 1 hr Post Infusion |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-Olaratumab Antibodies (ADA) | Percentage of Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20. | All enrolled participant who had any amount of olaratumab and evaluable anti-olaratumab antibody data. | Posted | Number | percentage of participants | Start of Treatment to 30-day Post Infusion Follow Up (Up to 6 Months) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-Ramucirumab Antibodies (ADA) | Percentage of Participants with Treatment Emergent (TE) anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20. | All enrolled participants who had any amount of ramucirumab and evaluable anti-ramucirumab antibodies. | Posted | Number | percentage of participants | Start of Treatment to 30-day Post Infusion Follow Up (Up to 6 Months) |
|
|
Not provided
Not provided
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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 | Group 1 Ramucirumab | Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. | 13 | 40 | 38 | 40 | ||
| EG001 | Group 2 Olaratumab | Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. | 14 | 40 | 39 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gastric hemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Shunt infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Incorrect storage of drug | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Medication error | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Brain edema | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cerebral hematoma | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hemorrhage intracranial | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vasogenic cerebral edema | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Faecal incontinence | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypoesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Amenorrhea | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dysmenorrhea | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
In accordance with the ABTC publication, JHU will submit the draft of any proposed publication to ImClone at least thirty (30) days prior to submission for publication and agrees to withhold any such submission for an additional period, not to exceed ninety (90) days to allow ImClone to file patent applications. If Confidential Information is in the publication, it will notify JHU, which will insure such Confidential Information is redacted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jaishri Blakely | Sidney Kimmel Comprehensive Cancer Center | (410) 955-8893 |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D001932 | Brain Neoplasms |
| D018316 | Gliosarcoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000589393 | olaratumab |
| D000096662 | Ramucirumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
|
Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Cmin (n=5) |
| |||||
| Cmax (n=6) |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Cmin (n=5) |
| |||||
| Cmax (n=5) |
|
|
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