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| ID | Type | Description | Link |
|---|---|---|---|
| NJ 1107 | Other Identifier | CINJOG | |
| 0220070284 | Other Identifier | IRB # | |
| NCI-2012-00525 | Other Identifier | NCI # | |
| 0220070284 | Other Identifier | Rutgers Cancer Institute of New Jersey | |
| Pro2018001861 | Other Identifier | Rutgers IRB# |
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| Name | Class |
|---|---|
| Rutgers Cancer Institute of New Jersey | OTHER |
| National Cancer Institute (NCI) | NIH |
| Bayer | INDUSTRY |
| Novartis Pharmaceuticals |
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Letrozole is an aromatase inhibitor that is approved in the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. This phase I/II trial is studying the side effects and best dose of sorafenib when given in combination with letrozole and to see how well they work in treating postmenopausal women with metastatic breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorafenib and Letrozole | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib | Drug | sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Sorafenib in Combination With Fixed Dose of of 2.5mg of Letrozole Maximum Tolerated Dose (MTD) | The highest dose of the drug that does not cause unacceptable side effects. The maximum tolerated dose be testing increasing doses until the highest dose with acceptable side effects is found. | twenty eight days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Benefit Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines (Version 1.1) to Letrozole and Sorafenib | Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the malignant lymph nodes are used for tumor measurements. Included will be: complete response, partial response or stable disease of letrozole and sorafenib in the treatment of postmenopausal participants with hormone receptor- positive locally advanced or metastatic breast cancer. Clinical Benefit Rate (CBR) = Progressive Free (PF) + Stable Disease (SD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoinette Tan, MD | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States | ||
| Emory University |
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13 participants in Phase I + 39 participants enrolled in Phase II = 52 participants that appear to be enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level -1 | Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study. Dose Level -1: Sorafenib 400mg po every other day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28 |
| FG001 | Phase l Sorafenib Dose Escalation and Letrozole 2.5mg Daily Dose Level 0:Sorafenib 400mg 1X Daily | Sorafenib: s dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study Dose Level 0: Sorafenib 400mg 1X daily Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28 |
| FG002 | Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level 1: Sorafenib 400mg 2X Day | Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study. Dose Level 1: Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28 |
| FG003 | Phase II Arm - Sorafenib at MTD (400mg) 2x a Day + Letrozole 2.5 mg po Daily | Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level -1 | Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study. Dose Level -1: Sorafenib 400mg po every other day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28 |
| 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 | Sorafenib in Combination With Fixed Dose of of 2.5mg of Letrozole Maximum Tolerated Dose (MTD) | The highest dose of the drug that does not cause unacceptable side effects. The maximum tolerated dose be testing increasing doses until the highest dose with acceptable side effects is found. | The primary outcome is the maximum tolerated dose, which is the highest dose of the drug that does not cause unacceptable side effects. The maximum tolerated dose was only analyzed. Then phase 2 added 39 participates. | Posted | Number | milligrams twice daily | twenty eight days |
|
Approximately 4.6 years
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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 | Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level -1 | Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study. Dose Level -1: Sorafenib 400mg po every other day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatology/Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Deborah Toppmeyer | Cancer Institute of New Jersey | 732-235-5203 | toppmede@cinj.rutgers.edu |
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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 | Jul 8, 2014 | Jan 25, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 13, 2013 | Dec 13, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| INDUSTRY |
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|
| Letrozole | Drug | Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28 |
|
|
| 6 months |
| Median Progressive-Free Survival (PFS) | PFS based on the Kaplan-Meier method is defined as the time between randomization and documented disease progression (PD) per RECIST 1,0 criteria or death, or is censored at time of last disease assessment. Per RECIST 1.0f or target lesions, PD is at least a 20% increase in sum LD of target lesions, taken as reference the smallest sum LD recorded at treatment started. Based on the time between the first day of treatment and and the date of disease progression. | Approximately 4.6 years |
| Overall Survival (OS) Assessed as Mean Months | From the start of treatment to the end of the study (three years) that participants are still alive. Measured by the mean number. | Approximately 4.6 years |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| Cooper Hospital/University Medical Center | Voorhees Township | New Jersey | 08690 | United States |
| BG001 | Phase l Sorafenib Dose Escalation and Letrozole 2.5mg Daily Dose Level 0:Sorafenib 400mg 1X Daily | Sorafenib: s dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study Dose Level 0: Sorafenib 400mg 1X daily Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28 |
| BG002 | Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level 1: Sorafenib 400mg 2X Day | Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study. Dose Level 1: Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28 |
| BG003 | Phase II Arm - Sorafenib at MTD (400mg) 2x a Day + Letrozole 2.5 mg po Daily | Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Clinical Benefit Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines (Version 1.1) to Letrozole and Sorafenib | Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the malignant lymph nodes are used for tumor measurements. Included will be: complete response, partial response or stable disease of letrozole and sorafenib in the treatment of postmenopausal participants with hormone receptor- positive locally advanced or metastatic breast cancer. Clinical Benefit Rate (CBR) = Progressive Free (PF) + Stable Disease (SD) | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Median Progressive-Free Survival (PFS) | PFS based on the Kaplan-Meier method is defined as the time between randomization and documented disease progression (PD) per RECIST 1,0 criteria or death, or is censored at time of last disease assessment. Per RECIST 1.0f or target lesions, PD is at least a 20% increase in sum LD of target lesions, taken as reference the smallest sum LD recorded at treatment started. Based on the time between the first day of treatment and and the date of disease progression. | Posted | Median | Full Range | months | Approximately 4.6 years |
|
|
|
| Secondary | Overall Survival (OS) Assessed as Mean Months | From the start of treatment to the end of the study (three years) that participants are still alive. Measured by the mean number. | Posted | Mean | Full Range | months | Approximately 4.6 years |
|
|
|
| 1 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Phase l Sorafenib Dose Escalation and Letrozole 2.5mg Daily Dose Level 0:Sorafenib 400mg 1X Daily | Sorafenib: s dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study Dose Level 0: Sorafenib 400mg 1X daily Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28 | 2 | 3 | 1 | 3 | 3 | 3 |
| EG002 | Phase l Sorafenib Dose Escalation and Letrozole 2.5mg po Daily Dose Level 1: Sorafenib 400mg 2X Day | Sorafenib: sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study. Dose Level 1: Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28 | 7 | 9 | 0 | 9 | 9 | 9 |
| EG003 | Phase II Arm - Sorafenib at MTD (400mg) 2x a Day + Letrozole 2.5 mg po Daily | Sorafenib 400mg 2X day. Letrozole: Patients will take letrozole orally at a daily dose of 2.5 mg/day | 24 | 39 | 3 | 39 | 39 | 39 |
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hepatobiliary | Hepatobiliary disorders | Systematic Assessment |
|
| Pain - Headaches | General disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Vascular | Vascular disorders | Systematic Assessment |
|
| Cardiac | Cardiac disorders | Systematic Assessment |
|
| General | General disorders | Systematic Assessment |
|
| Blood | Blood and lymphatic system disorders | Systematic Assessment |
|
| Reproductive | Reproductive system and breast disorders | Systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| constitutional Symptoms | General disorders | Systematic Assessment |
|
| Metabolic | General disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |