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| Name | Class |
|---|---|
| National Comprehensive Cancer Network | NETWORK |
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This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the study drug tivozanib is still being studied. It also means that the FDA has not yet approved tivozanib for your type of cancer.
Tivozanib is an anti-angiogenesis medicine that fights different types of cancer by blocking the blood supply to the tumor, so that the tumor does not receive the nutrients it requires to grow.
In this research study, we are looking to see what effects, good and bad, tivozanib will have on you and your disease.
If you are willing to participate in this study, you will be asked to undergo some screening tests and procedures that confirm you are eligible. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out taht you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. The screening process may include the following: a medical history, mini-mental status exam, physical exam, performance status, electrocardiogram, blood tests, urine test. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.
If you take part in this research study, you will be given a study drug-dosing calendar for each treatment cycle. Each treatment cycle lasts 28 days (4 weeks) during which time you will be taking the study drug once daily for 3 weeks and then no study drug for the last week of each cycle. The diary will also include special instructions for taking the study drug.
During all cycles you will have a physical exam and you will be asked questions about your general health and specific questions about any problems that you might be having and any medications you may be taking.
Standard contrast-enhanced (CE) MRI scans will be done prior to all odd-numbered study cycles. Vascular MRI scans will be done prior to start of treatment, Day 1 of treatment and prior to all even-numbered cycles. These studies will be done in the Charlestown Navy Yard.
We would like to keep track of your medical condition for up to 24 months after your last dose of study treatment. We would like to do this by calling you on the telephone once a year to see how you are doing. Keeping in touch with you and checking your condition every year helps us look at the long-term effects of the research study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tivozanib | Experimental | 1.5 mg daily for 3 weeks, with 1 week off. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tivozanib | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Alive and Progression Free After 6 Months | To determine the number of patients with recurrent glioblastoma (GBM) alive and progression free 6 months (PFR6) after start of tivozanib therapy | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Related Serious Adverse Events | The number of participants with serious adverse events deemed possibly, probably, or definitely related to treatment. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4). | From the start of treatment until disease progression, unacceptable toxicity, or death; median duration of approximately 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Gerstner, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tivozanib | 1.5 mg daily for 3 weeks, with 1 week off. Tivozanib |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tivozanib | 1.5 mg daily for 3 weeks, with 1 week off. Tivozanib |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Alive and Progression Free After 6 Months | To determine the number of patients with recurrent glioblastoma (GBM) alive and progression free 6 months (PFR6) after start of tivozanib therapy | Posted | Count of Participants | Participants | 6 months |
|
|
From the start of treatment until disease progression, unacceptable toxicity, or death; median duration of approximately 2 months.
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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 | Tivozanib | 1.5 mg daily for 3 weeks, with 1 week off. Tivozanib | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abducens nerve disorder | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elizabeth Gerstner | Massachusetts General Hospital | 617-724-8770 | EGERSTNER@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| C553176 | tivozanib |
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| Median Overall Survival | Overall survival is measured from the start of treatment until the time of death. | From the start of treatment until the time of death, median duration of approximately 8 months |
| Median Progression-Free Survival | Progression free survival is measured as the amount of time from the start of treatment until the time of death or disease progression. Progressive disease was assessed using MacDonald Criteria Progressive disease: Progressive neurologic abnormalities not explained by causes unrelated to tumor 40 progression (example: anti-epileptic drug or corticosteroid toxicity, electrolyte abnormalities, hyperglycemia, etc.) or a greater than 25% increase in the volume of the tumor by MRI scan. If neurologic status deteriorates on a stable or increasing dose of corticosteroids, or if new lesions appear on serial MRI scans, this will also be considered PD. | From the start of treatment until death or progression, median duration of approximately 2 months |
| Best RANO Criteria Response | Best response as assessed by Response Assessment in Neuro-Oncology (RANO) criteria. Complete response
Partial response >50% or more decrease of all measurable enhancing lesions
Stable disease
Progression >25% or more increase in enhancing lesions despite stable/increasing steroid dose
| 2 years |
| Steroid Dosage | The number of participants on steroids at baseline and the number of participants that increased or decreased their use of steroids during the course of treatment. Participants that required an increase and decrease in steroid use over the course of treatment were counted in both categories. | 2 years |
| Change in Tumor Volume | Change in volume of the tumor in cubic centimeters at the given time points as compared to baseline | Baseline, Cycle 1 day 2, pre-cycle 2, pre-cycle 3 (1 cycle= 4 weeks) |
| Median Apparent Diffusion Coefficient (ADC) | Change in the the median ADC value from baseline at the given timepoints. Apparent diffusion coefficient (ADC) is a measure of the magnitude of diffusion (of water molecules) within tissue. | Baseline, Cycle 1 day 2, pre-cycle 2, pre-cycle 3 (1 cycle= 4 weeks) |
| Median Ktrans | Change in the the median Ktrans value from baseline at the given time points. The volume transfer constant (Ktrans) reflects the efflux rate of gadolinium contrast from blood plasma into the tissue extravascular extracellular space (EES) | Baseline, Cycle 1 day 2, pre-cycle 2, pre-cycle 3 (1 cycle= 4 weeks) |
| Relative Oxygen Saturation | The change in relative O2 saturation from baseline to the given time points. Oxygen saturation is a relative measure of the concentration of oxygen that is dissolved or carried in a given medium as a proportion of the maximal concentration that can be dissolved in that medium. | Baseline, Cycle 1 day 2, pre-cycle 2, pre-cycle 3 (1 cycle= 4 weeks) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Secondary | Number of Participants With Treatment Related Serious Adverse Events | The number of participants with serious adverse events deemed possibly, probably, or definitely related to treatment. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4). | Posted | Count of Participants | Participants | From the start of treatment until disease progression, unacceptable toxicity, or death; median duration of approximately 2 months |
|
|
|
| Secondary | Median Overall Survival | Overall survival is measured from the start of treatment until the time of death. | Posted | Median | 95% Confidence Interval | Months | From the start of treatment until the time of death, median duration of approximately 8 months |
|
|
|
| Secondary | Median Progression-Free Survival | Progression free survival is measured as the amount of time from the start of treatment until the time of death or disease progression. Progressive disease was assessed using MacDonald Criteria Progressive disease: Progressive neurologic abnormalities not explained by causes unrelated to tumor 40 progression (example: anti-epileptic drug or corticosteroid toxicity, electrolyte abnormalities, hyperglycemia, etc.) or a greater than 25% increase in the volume of the tumor by MRI scan. If neurologic status deteriorates on a stable or increasing dose of corticosteroids, or if new lesions appear on serial MRI scans, this will also be considered PD. | Posted | Median | 95% Confidence Interval | Months | From the start of treatment until death or progression, median duration of approximately 2 months |
|
|
|
| Secondary | Best RANO Criteria Response | Best response as assessed by Response Assessment in Neuro-Oncology (RANO) criteria. Complete response
Partial response >50% or more decrease of all measurable enhancing lesions
Stable disease
Progression >25% or more increase in enhancing lesions despite stable/increasing steroid dose
| Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Steroid Dosage | The number of participants on steroids at baseline and the number of participants that increased or decreased their use of steroids during the course of treatment. Participants that required an increase and decrease in steroid use over the course of treatment were counted in both categories. | Posted | Number | participants | 2 years |
|
|
|
| Secondary | Change in Tumor Volume | Change in volume of the tumor in cubic centimeters at the given time points as compared to baseline | Measurements were not available for all participants at pre-cycle 2 and pre-cycle 3 | Posted | Median | Inter-Quartile Range | Cubic Centimeters | Baseline, Cycle 1 day 2, pre-cycle 2, pre-cycle 3 (1 cycle= 4 weeks) |
|
|
|
|
| Secondary | Median Apparent Diffusion Coefficient (ADC) | Change in the the median ADC value from baseline at the given timepoints. Apparent diffusion coefficient (ADC) is a measure of the magnitude of diffusion (of water molecules) within tissue. | Posted | Median | Inter-Quartile Range | mm2/s | Baseline, Cycle 1 day 2, pre-cycle 2, pre-cycle 3 (1 cycle= 4 weeks) |
|
|
|
|
| Secondary | Median Ktrans | Change in the the median Ktrans value from baseline at the given time points. The volume transfer constant (Ktrans) reflects the efflux rate of gadolinium contrast from blood plasma into the tissue extravascular extracellular space (EES) | Posted | Median | Inter-Quartile Range | mL/min/100 mL | Baseline, Cycle 1 day 2, pre-cycle 2, pre-cycle 3 (1 cycle= 4 weeks) |
|
|
|
|
| Secondary | Relative Oxygen Saturation | The change in relative O2 saturation from baseline to the given time points. Oxygen saturation is a relative measure of the concentration of oxygen that is dissolved or carried in a given medium as a proportion of the maximal concentration that can be dissolved in that medium. | One participants was not available for assessment for the cycle 1 day 2 measurement | Posted | Median | Inter-Quartile Range | proportion of possible O2 concentration | Baseline, Cycle 1 day 2, pre-cycle 2, pre-cycle 3 (1 cycle= 4 weeks) |
|
|
|
|
| 10 |
| 2 |
| 10 |
| 9 |
| 10 |
| Edema cerebral | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Colonic perforation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Ataxia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cognitive disturbance | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ear and labyrinth disorders - Other, cerumen in right ear | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ear and labyrinth disorders - Other, hearing loss in right ear | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ear and labyrinth disorders - Other, Intermittent hearing loss | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Eye disorders - Other, Hemanopsia | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Eye disorders - Other, Retro Orbital pressure | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gait disturbance | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, SGOT elevated | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, SGPT elevated | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muscle weakness left-sided | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muscle weakness right-sided | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nervous system disorders - Other, Altered Coordination (right) | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nervous system disorders - Other, Cognitive Dysfunction | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nervous system disorders - Other, numbness right limbs | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nervous system disorders - Other, Speech impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nystagmus | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Paronychia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pyramidal tract syndrome | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Voice alteration | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
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| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| Title | Measurements |
|---|---|
|
| Progressive disease |
|
| No change |
|