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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
| Brigham and Women's Hospital | OTHER |
| Massachusetts General Hospital | OTHER |
| Novartis |
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This research study will test the safety of RAD001 in combination with temozolomide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temozolomide with RAD001 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAD001 | Drug | Given orally once a day |
| |
| Temozolomide |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | To determine the objective response rate by RECIST criteria of RAD001 in combination with temozolomide in patients with advanced pancreatic neuroendocrine tumors. Partial response (PR) by these criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Progressive disease (PD) is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD) is defined as neither sufficient decrease to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | To determine progression-free survival when RAD001 is given in combination with temozolomide in patients with advanced pancreatic neuroendocrine tumors. Progression-free survival is defined as time from start of therapy until disease progression, as defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or death. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Chan, MD, PhD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Dana-Farber Cancer Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Temozolomide and Everolimus | Temozolomide was administered to all patients at a starting dose of 150 mg/m2 on days 1 to 7 and days 15 to 21 of a 28-day cycle. Everolimus was administered together with temozolomide in 2 dose cohorts: 1) 5 mg daily and 2) 10 mg daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Temozolomide and Everolimus | Temozolomide was administered to all patients at a starting dose of 150 mg/m2 on days 1 to 7 and days 15 to 21 of a 28-day cycle. Everolimus was administered together with temozolomide in 2 dose cohorts: 1) 5 mg daily and 2) 10 mg daily. |
| 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 | Response Rate | To determine the objective response rate by RECIST criteria of RAD001 in combination with temozolomide in patients with advanced pancreatic neuroendocrine tumors. Partial response (PR) by these criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Progressive disease (PD) is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD) is defined as neither sufficient decrease to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. | Posted | Count of Participants | Participants | 2 years |
|
Participants were followed for development of adverse events for the entire duration while receiving treatment and for 30 days following their last dose of study treatment. Patients in this trial received a median of 8.5 four-week treatment cycles (range, 1-28). Each participant was followed for adverse events for 30 days following his or her last dose of study treatment.
All-grade adverse events possible or definitely related to treatment are reported.
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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 | Temozolomide and Everolimus | Temozolomide was administered to all patients at a starting dose of 150 mg/m2 on days 1 to 7 and days 15 to 21 of a 28-day cycle. Everolimus was administered together with temozolomide in 2 dose cohorts: 1) 5 mg daily and 2) 10 mg daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Chan | Dana-Farber Cancer Institute | 617-632-6315 | jang@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 7, 2019 | Apr 24, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007516 | Adenoma, Islet Cell |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D003606 |
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| INDUSTRY |
| Schering-Plough | INDUSTRY |
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| Drug |
Taken orally once a day for one week followed by a one-week break period |
|
|
| 2 years |
| To Determine the Safety and Tolerability of This Drug Combination. | To determine the safety and tolerability of RAD001 when given in combination with temozolomide in patients with advanced pancreatic neuroendocrine tumors. | 2 years |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| 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 |
|
Temozolomide was administered to all patients at a starting dose of 150 mg/m2 on days 1 to 7 and days 15 to 21 of a 28-day cycle. Everolimus was administered together with temozolomide in 2 dose cohorts: 1) 5 mg daily and 2) 10 mg daily.
|
|
| Secondary | Progression-free Survival | To determine progression-free survival when RAD001 is given in combination with temozolomide in patients with advanced pancreatic neuroendocrine tumors. Progression-free survival is defined as time from start of therapy until disease progression, as defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or death. | Posted | Median | 95% Confidence Interval | months | 2 years |
|
|
|
| Secondary | To Determine the Safety and Tolerability of This Drug Combination. | To determine the safety and tolerability of RAD001 when given in combination with temozolomide in patients with advanced pancreatic neuroendocrine tumors. | Posted | Count of Participants | Participants | 2 years |
|
|
|
| 2 |
| 43 |
| 15 |
| 43 |
| 43 |
| 43 |
| neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| hypocalcemia | Investigations | Systematic Assessment |
|
| creatinine | Renal and urinary disorders | Systematic Assessment |
|
| hypophosphatemia | Investigations | Systematic Assessment |
|
| pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| lymphopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | Systematic Assessment |
|
| Hyperglycemia | Endocrine disorders | Systematic Assessment |
|
| Hypercholesterolemia | General disorders | Systematic Assessment |
|
| Lymphocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
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| D010190 |
| Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| Dacarbazine |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
| Grade 3 or 4 hyperglycemia |
|
| Grade 3 or 4 AST Increase |
|
| Grade 3 or 4 Leukocyte decrease |
|