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This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not approved the drug for this type of cancer, or for any use outside of research studies.
When cancer spreads from the primary tumor, one of the most commons sites it spreads to is bone. When cancer spreads to bone there can be significant symptoms such as pain.
Cabozantinib works by blocking signaling that leads to cancer growth as well as blocking the growth of new blood vessels (angiogenesis) that help to feed a tumor. Cabozantinib has been studied or is being studied in research studies as a possible treatment for various types of cancer, including prostate cancer, brain cancer, thyroid cancer, lung cancer and kidney cancer.
Previous clinical research studies indicate that cabozantinib may also have activity against cancer once it has spread to the bones.
The purpose of this study is to find out if cabozantinib is effective in treating cancer that has spread to the bone.
Cabozantinib is a tablet that the subject will take by mouth. The subject will take it once per day. The study treatment with cabozantinib will be divided into 28 day cycles. A member of the study staff will give the subject a drug diary and explain to the subject how to use it to record doses of cabozantinib. This diary will also contain specific instructions about how the subject take cabozantinib.
Every 28 days the subject will undergo the following procedures: Physical examination, questions about any side effects the subject may have, blood samples for routine laboratory tests and research tests, urine sample, electrocardiogram (EKG), and questionnaires to measure quality of life and level of pain. Every two months the subject will undergo a CT scan or MRI to evaluate the subjects disease.
The investigators would like the subject to return to the study clinic for follow-up procedures about 4-5 weeks after the last dose of cabozantinib.
The subject can continue to receive the study drug for as long as their disease does not worsen and the subject do not experience unacceptable side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Cabozantinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabozantinib | Drug | 60 mg daily by mouth |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Bone Bio-marker Response | Effect of cabozantinib on bone biomarkers of osteoblast and osteoclast activity. The bio-markers of interest were serum C-terminal telopeptide (Ctx), urine N-terminal telopeptide (Ntx), serum (Ntx). Participants were considered to have a response if there was at least a 40% decrease in the bio-marker concentration. | 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Skeletal-related Events (SRE) | The number of patients that experience a SRE in patients treated with cabozantinib (SRE defined as pathologic fracture, cord compression, radiation or surgery to bone, hypercalcemia) | 2 years |
| Quality of Life as Assessed by FACT-G |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Heist, MD | MGH | 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 | Cabozantinib | Cabozantinib: 60 mg daily by mouth |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cabozantinib | Cabozantinib: 60 mg daily by mouth |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Participants With Bone Bio-marker Response | Effect of cabozantinib on bone biomarkers of osteoblast and osteoclast activity. The bio-markers of interest were serum C-terminal telopeptide (Ctx), urine N-terminal telopeptide (Ntx), serum (Ntx). Participants were considered to have a response if there was at least a 40% decrease in the bio-marker concentration. | Only 19 participants were evaluable for determination of response by bone bio-markers | Posted | Count of Participants | Participants | 8 Weeks |
|
|
Beginning at the start of treatment, adverse events are assessed every 2 weeks for the first 3 months and then on a monthly basis up until 30 days after the last dose of Cabozantinib is received. Overall adverse event data collection is ongoing. Data represents all adverse events collected at the time of initial data analysis.
Participants are assessed with the use of physical exams, laboratory tests, electrocardiograms (EKG), and by participant self reporting.
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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 | Cabozantinib | Cabozantinib: 60 mg daily by mouth | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Suk Heist, MD | Massachusetts General Hospital | 617-724-4000 | rheist@partners.org |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D011471 | Prostatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C558660 | cabozantinib |
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Quality of life as measured by the Functional Assessment of Cancer Therapy - General (FACT-G). FACT-G assesses patients' physical, social/family, emotional, and functional well-being. The total score can range from 0 to 108, with lower scores indicating higher quality of life. Patients without QOL scores at cycle 3 day 1 had their score from their last assessment carried forward. |
| From baseline to Cycle 3 Day 1 (approximately 2 months) |
| Overall Tumor Response Rate | The number of participants with a complete or partial response as measured by bone scan or PET-CT scan using. Response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
| 2 years |
| MET Amplification in Tumor Sample | Response will be correlated with specific tumor genotype (MET amplification). | 2 years |
| Response to Cabozantinib in Bone Metastatic Disease | Response to cabozantinib in bone metastatic disease as measured by bone scan or PET-CT scan | 2 years |
| Time to SRE | Time to SRE in patients treated with cabozantinib (SRE defined as pathologic fracture, cord compression, radiation or surgery to bone, hypercalcemia) | 2 years |
| 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 | Number | participants |
|
| Diagnosis | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Number of Patients With Skeletal-related Events (SRE) | The number of patients that experience a SRE in patients treated with cabozantinib (SRE defined as pathologic fracture, cord compression, radiation or surgery to bone, hypercalcemia) | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Quality of Life as Assessed by FACT-G | Quality of life as measured by the Functional Assessment of Cancer Therapy - General (FACT-G). FACT-G assesses patients' physical, social/family, emotional, and functional well-being. The total score can range from 0 to 108, with lower scores indicating higher quality of life. Patients without QOL scores at cycle 3 day 1 had their score from their last assessment carried forward. | Posted | Median | Full Range | units on a scale | From baseline to Cycle 3 Day 1 (approximately 2 months) |
|
|
|
| Secondary | Overall Tumor Response Rate | The number of participants with a complete or partial response as measured by bone scan or PET-CT scan using. Response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
| The 20 participants that were able to be evaluated for response. The other 17 participants had bone only disease | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | MET Amplification in Tumor Sample | Response will be correlated with specific tumor genotype (MET amplification). | MET amplification testing was not done due to insufficient tumor material available for testing | Posted | 2 years |
|
|
| Secondary | Response to Cabozantinib in Bone Metastatic Disease | Response to cabozantinib in bone metastatic disease as measured by bone scan or PET-CT scan | Bone scan response assessment not done | Posted | 2 years |
|
|
| Secondary | Time to SRE | Time to SRE in patients treated with cabozantinib (SRE defined as pathologic fracture, cord compression, radiation or surgery to bone, hypercalcemia) | No SRE events occurred | Posted | 2 years |
|
|
| 37 |
| 9 |
| 37 |
| 37 |
| 37 |
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Meningitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cardiac disorders - Other, specify | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Malaise | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| General disorders and administration site conditions - Other, | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Endocrine disorders - Other, specify | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Congenital, familial and genetic disorders - Other, specify | Congenital, familial and genetic disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Oral dysesthesia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hepatobiliary disorders - Other, specify | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Meningitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Prostate infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Injury, poisoning and procedural complications - Other, specify | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| CPK increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Lipase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Serum amylase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specify | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nervous system disorders - Other, specify | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Glaucoma | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Eye disorders - Other, specify | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal 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 |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |