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| ID | Type | Description | Link |
|---|---|---|---|
| CSOM230CUS09T |
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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Massachusetts General Hospital | OTHER |
| Beth Israel Deaconess Medical Center | OTHER |
| Memorial Sloan Kettering Cancer Center |
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The purpose of this research study is to evaluate the effectiveness and safety of SOM230C in treating recurrent meningiomas. SOM230C is a newly discovered drug that may stop meningioma cells from growing abnormally. This drug has been used in treatment of other tumors, and information from those other research studies suggests that SOM230C may help to stop the growth of meningiomas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOM230C | Experimental | Monthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOM230C | Drug | Injection in the buttocks every 28 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 6 Month Progression Free Survival | Progression is defined using Modified Macdonald Criteria , using a >/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | Number of participants to experience complete or partial response on study treatment. For response per Modified Macdonald Criteria, all measurable and evaluable lesions and sites must be assessed using the same techniques as baseline.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Y. Wen, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Northwestern University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Atypical/Malignant Meningiomas | participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days |
| FG001 | Participants With Benign Meningiomas | participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Atypical/Malignant Meningiomas | participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days |
| BG001 | Participants With Benign Meningiomas |
| 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 | 6 Month Progression Free Survival | Progression is defined using Modified Macdonald Criteria , using a >/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). | Posted | Number | percentage of patients | 6 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 | SOM230C | Monthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial) SOM230C: Injection in the buttocks every 28 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| somnolence | Nervous system disorders | CTCAE v. 3 | grade 3 somnolence with vomiting and left-sided weakness resulting in hospitalization (unlikely related to & unexpected with SOM230C) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hearing w/o audiogr not in monitor prg | Ear and labyrinth disorders | CTCAE v. 3 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrick Y. Wen, MD | Dana-Farber Cancer Institute / Brigham & Women's Hospital | 617-632-2166 | pwen@partners.org |
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| ID | Term |
|---|---|
| D008579 | Meningioma |
| ID | Term |
|---|---|
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009383 | Neoplasms, Vascular Tissue |
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| OTHER |
| Wake Forest University Health Sciences | OTHER |
| Duke University | OTHER |
| Cedars-Sinai Medical Center | OTHER |
| Northwestern University | OTHER |
| Novartis | INDUSTRY |
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| 5 years |
| Treatment-related Events | All Grade 3-4-5 adverse events with a treatment attribution of probable, possible or definite based on CTCAE (v3.0) as reported on case report forms | 5 years |
| Median Progression-Free Survival | 5 years |
| Median Time to Progression | Per protocol, the study's secondary objectives are to be evaluated "for the estimate of median ... PFS ... at time of interest." At this time, all study participants have been followed for progression for a minimum of 34 months (final patient to accrue to study was registered to trial on 06/14/2011), and study manuscript is currently being written-up with this information. | 34 months |
| Overall Survival | Percentage of participants alive 34 months after initiating study treatment. Median Overall Survival has not yet been reached for one study group; therefore, we are reporting Overall Survival rates by the end of the study time frame. | 34 months |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Duke University Medical Center, Preston Robert Tisch Brain Tumor Center | Durham | North Carolina | 27710 | United States |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| KPS scores | 100% = Normal; 90% = Normal activity, minor signs/symptoms; 80% = Normal activity w/ effort, some signs/symptoms; 70% = Cares for self, unable to do normal activity/active work; 60% = Requires occasional assistance, but cares for most personal needs; 50% = Requires considerable assistance/frequent medical care; 40% = Disabled, requires special care & assistance; 30% = Severely disabled, hospital admission is indicated but death not imminent; 20% = Very sick, hospitalization necessary, active supportive treatment necessary; 10% = Moribund, fatal processes progressing rapidly; 0% = Dead. | Median | Full Range | percent |
|
| Participants With Benign Meningiomas |
participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days |
|
|
| Secondary | Response Rate | Number of participants to experience complete or partial response on study treatment. For response per Modified Macdonald Criteria, all measurable and evaluable lesions and sites must be assessed using the same techniques as baseline.
| Posted | Number | participants | 5 years |
|
|
|
| Secondary | Treatment-related Events | All Grade 3-4-5 adverse events with a treatment attribution of probable, possible or definite based on CTCAE (v3.0) as reported on case report forms | Posted | Number | events | 5 years |
|
|
|
| Secondary | Median Progression-Free Survival | Posted | Median | 95% Confidence Interval | weeks | 5 years |
|
|
|
| Secondary | Median Time to Progression | Per protocol, the study's secondary objectives are to be evaluated "for the estimate of median ... PFS ... at time of interest." At this time, all study participants have been followed for progression for a minimum of 34 months (final patient to accrue to study was registered to trial on 06/14/2011), and study manuscript is currently being written-up with this information. | Time to progression only reported for the 32 patients who have progressed (either on treatment or in follow-up). [NOTE: The other 2 patients who were treated on study each remain progression-free after > 1000 days.] | Posted | Median | Full Range | days | 34 months |
|
|
|
| Secondary | Overall Survival | Percentage of participants alive 34 months after initiating study treatment. Median Overall Survival has not yet been reached for one study group; therefore, we are reporting Overall Survival rates by the end of the study time frame. | Posted | Number | percentage of participants | 34 months |
|
|
|
| 7 |
| 34 |
| 34 |
| 34 |
|
| hypoglycemia | Metabolism and nutrition disorders | CTCAE v. 3 | grade 4 hypoglycemia (w/ hospitalization), with anemia (grade 3 hemoglobin); unrelated to and unexpected with SOM230C. |
|
| hyperglycemia | Metabolism and nutrition disorders | CTCAE v. 3 | grade 4 hyperglycemia (w/ hospitalization); definitely related to and expected with SOM230C. |
|
| subdural hematoma | Vascular disorders | CTCAE v. 3 | grade 4 subdural hematoma (w/ hospitalization); unrelated to and unexpected with SOM230C |
|
| secondary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v. 3 | grade 3 secondary malignancy (squamous cell carcinoma); unrelated to and unexpected with SOM230C. |
|
| muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE v. 3 | Gr 3 lower extremity weakness/decline (w/ hosp); unrelated & unexpected. |
|
| extremity-lower (gait/walking) | Musculoskeletal and connective tissue disorders | CTCAE v. 3 | grade 3 lower extremity (gait/walking) complications (w/ hospitalization); unrelated to and unexpected with SOM230C. |
|
| sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE v. 3 | grade 3 hyponatremia w/ hallucinations (w/ hospitalization); unrelated to and unexpected with SOM230C. |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE v. 3 |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE v. 3 |
|
| Leukocytes | Blood and lymphatic system disorders | CTCAE v. 3 |
|
| Neutrophils | Blood and lymphatic system disorders | CTCAE v. 3 |
|
| Platelets | Blood and lymphatic system disorders | CTCAE v. 3 |
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| QTc interval | Cardiac disorders | CTCAE v. 3 |
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| Sinus bradycardia | Cardiac disorders | CTCAE v. 3 |
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| Hypotension | Cardiac disorders | CTCAE v. 3 |
|
| Constitutional - Other | General disorders | CTCAE v. 3 |
|
| Fatigue | General disorders | CTCAE v. 3 |
|
| Insomnia | General disorders | CTCAE v. 3 |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE v. 3 |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE v. 3 |
|
| Skin - Other | Skin and subcutaneous tissue disorders | CTCAE v. 3 |
|
| Thyroid function, high (hyperthyroidism, thyrotoxicosis) | Endocrine disorders | CTCAE v. 3 |
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| Anorexia | Metabolism and nutrition disorders | CTCAE v. 3 |
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| Constipation | Gastrointestinal disorders | CTCAE v. 3 |
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| Dehydration | Metabolism and nutrition disorders | CTCAE v. 3 |
|
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | CTCAE v. 3 |
|
| Dysphagia | Gastrointestinal disorders | CTCAE v. 3 |
|
| Flatulence | Gastrointestinal disorders | CTCAE v. 3 |
|
| GI - Other | Gastrointestinal disorders | CTCAE v. 3 |
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| Nausea | Gastrointestinal disorders | CTCAE v. 3 |
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| Taste DIsturbance | Nervous system disorders | CTCAE v. 3 |
|
| Vomiting | Gastrointestinal disorders | CTCAE v. 3 |
|
| Infection Gr0-2 neut- upper airway | Infections and infestations | CTCAE v. 3 |
|
| Infection Gr0-2 neut- urinary tract | Infections and infestations | CTCAE v. 3 |
|
| Infection - Other | Infections and infestations | CTCAE v. 3 |
|
| Alkaline phosphatase | Investigations | CTCAE v. 3 |
|
| ALT - SGPT | Investigations | CTCAE v. 3 |
|
| Amylase | Investigations | CTCAE v. 3 |
|
| AST - SGOT | Investigations | CTCAE v. 3 |
|
| Creatinine | Investigations | CTCAE v. 3 |
|
| GGT | Investigations | CTCAE v. 3 |
|
| Cholesterol, serum-high (hypercholesteremia) | Investigations | CTCAE v. 3 |
|
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE v. 3 |
|
| Triglyceride, serum-high (hypertriglyceridemia) | Metabolism and nutrition disorders | CTCAE v. 3 |
|
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE v. 3 |
|
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE v. 3 |
|
| Glucose, serum-low (hypoglycemia) | Metabolism and nutrition disorders | CTCAE v. 3 |
|
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE v. 3 |
|
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE v. 3 |
|
| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders | CTCAE v. 3 |
|
| Lipase | Investigations | CTCAE v. 3 |
|
| Metabolic/Laboratory-other | Metabolism and nutrition disorders | CTCAE v. 3 |
|
| Extremity-lower (gait/walking) | General disorders | CTCAE v. 3 |
|
| Musculoskeletal/soft tissue-other | Musculoskeletal and connective tissue disorders | CTCAE v. 3 |
|
| Nonneuropathic generalized weakness | Musculoskeletal and connective tissue disorders | CTCAE v. 3 |
|
| Nonneuropathic lower extr muscle weak | Musculoskeletal and connective tissue disorders | CTCAE v. 3 |
|
| Nonneuropathic right-side muscle weak | Musculoskeletal and connective tissue disorders | CTCAE v. 3 |
|
| Mood Alteration: Anxiety | Psychiatric disorders | CTCAE v. 3 |
|
| Ataxia | Nervous system disorders | CTCAE v. 3 |
|
| Cognitive disturbance | Nervous system disorders | CTCAE v. 3 |
|
| Confusion | Psychiatric disorders | CTCAE v. 3 |
|
| Mood Alteration: Depression | Psychiatric disorders | CTCAE v. 3 |
|
| Dizziness | Nervous system disorders | CTCAE v. 3 |
|
| Memory Impairment | Nervous system disorders | CTCAE v. 3 |
|
| Neurologic - Other | Nervous system disorders | CTCAE v. 3 |
|
| Neuropathy CN V jaw / face-sensory | Nervous system disorders | CTCAE v. 3 |
|
| Neuropathy-motor | Nervous system disorders | CTCAE v. 3 |
|
| Neuropathy-sensory | Nervous system disorders | CTCAE v. 3 |
|
| Seizure | Nervous system disorders | CTCAE v. 3 |
|
| Speech Impairment | Nervous system disorders | CTCAE v. 3 |
|
| Ocular - Other | Eye disorders | CTCAE v. 3 |
|
| Pain - Abdomen NOS | Gastrointestinal disorders | CTCAE v. 3 |
|
| Pain - Back | Musculoskeletal and connective tissue disorders | CTCAE v. 3 |
|
| Pain - Extremity/Limb | Musculoskeletal and connective tissue disorders | CTCAE v. 3 |
|
| Pain - face | General disorders | CTCAE v. 3 |
|
| Pain - head/headache | Nervous system disorders | CTCAE v. 3 |
|
| Pain - oral cavity | Gastrointestinal disorders | CTCAE v. 3 |
|
| Pain - other | General disorders | CTCAE v. 3 |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v. 3 |
|
| Pulmonary/Upper Respiratory-other | Respiratory, thoracic and mediastinal disorders | CTCAE v. 3 |
|
| Incontinence, urinary | Renal and urinary disorders | CTCAE v. 3 |
|
| Renal/GU - Other | Renal and urinary disorders | CTCAE v. 3 |
|
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE v. 3 |
|
Not provided
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |
| Hypoglycemia |
|
| Hypokalemia |
|
| Lipase |
|