Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This research study is being done to measure the clinical benefit associated with cabozantinib (XL184) in men who have prostate cancer that has spread to visceral organs (organs other than bone or lymph nodes) and no longer responds to initial hormonal (castration) therapy. This type of prostate cancer is called metastatic, castrate-resistant prostate cancer.
Cabozantinib (XL184), a multi-targeted tyrosine kinase inhibitor, has demonstrated a powerful clinical phenotype in men with metastatic castrate resistant prostate cancer (mCRPC) both before and after chemotherapy. This phenotype consists of rapid reduction in pain (when present) and improvement in bone scans that may or may not be accompanied by decrease in serum prostate specific antigen (PSA) concentrations. In previous studies of cabozantinib in advanced prostate cancer, patients with visceral disease have been excluded. Hence, this protocol creates a unique opportunity to define the activity of this disease in the population of men with visceral disease - a marker for poorer prognosis in mCRPC.
Primary Objectives:
- To assess the clinical benefit (complete response + partial response + stable disease) of cabozantinib in patients with mCRPC with visceral metastases.
Secondary Objectives:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (cabozantinib) | Experimental | Cabozantinib 60mg orally daily until disease progression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabozantinib | Drug | Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Benefit Rate From Cabozantinib (XL184) | Clinical benefit rate is defined as the combination of complete response, partial response, and stable disease as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by CT imaging and Prostate Cancer Working Group 2 (PCWG2) criteria. Complete response (CR) defined as disappearance of all target lesions; Partial response (PR) >=30% decrease in som of diameters of target lesions (taking as reference the baseline), and stable disease, neither sufficient shrinkage to qualify for PR nor increase to qualify for progressive disease. | Baseline to 12 weeks after starting therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Circulating Tumor Cells (CTC) in Response to Cabozantinib | Change in number of CTC from baseline at 12 weeks | Baseline and 12 weeks |
| Number of Patients With NanoVelcro Appropriate for RNA in Circulating Tumor Cells |
Not provided
KEY INCLUSION CRITERIA
- mCRPC that includes visceral disease. Visceral metastatic disease is defined as solid organ infiltration that is not bone or lymph node metastases.
KEY EXCLUSION CRITERIA
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Edwin Posadas, MD FACP | Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Cabozantinib) | Cabozantinib 60mg orally daily until disease progression Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Cabozantinib) | Cabozantinib 60mg orally daily until disease progression Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression. |
| 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 | Clinical Benefit Rate From Cabozantinib (XL184) | Clinical benefit rate is defined as the combination of complete response, partial response, and stable disease as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by CT imaging and Prostate Cancer Working Group 2 (PCWG2) criteria. Complete response (CR) defined as disappearance of all target lesions; Partial response (PR) >=30% decrease in som of diameters of target lesions (taking as reference the baseline), and stable disease, neither sufficient shrinkage to qualify for PR nor increase to qualify for progressive disease. | Posted | Count of Participants | Participants | Baseline to 12 weeks after starting therapy |
|
From signed consent up to 30 days after last treatment
Attributions and ratings completed by Investigators as per CTCAE
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (Cabozantinib) | Cabozantinib 60mg orally daily until disease progression Cabozantinib: Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT increased | Investigations | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Edwin Posadas | Cedars-Sinai Medical Center | 310-423-7600 | Edwin.Posadas@cshs.org |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C558660 | cabozantinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
This is to provide a measure of feasibility using NanoVelcro to measure RNA in circulating tumor cells (CTC)
| 12 weeks |
| Change in Levels of Serum Hepatocyte Growth Factor (HGF) and Vascular Endothelial Growth Factor (VEGF) Concentration | Mean change from baseline in levels of HGF and VEGF | 12 weeks |
| Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4) | Each cycle is 28 days. Safety and tolerability was defined as related grade 3-4 AEs of doses of cabozantinib below 100 mg daily using common terminology criteria for adverse events (CTCAE) | Every 2 weeks for first 3 Cycles and every 4 weeks thereafter for an expected average of 28 weeks. |
| Number of Patients With Evaluable Protein Content of Large Oncosomes From Baseline to First Documented Progression or Date of Death | This is a feasibility outcome to assess ability to measure protein content in large oncosomes in this population. | From baseline until the date of first documented progression or date of death from any cause, whichever comes first, assessed for an expected average of 28 weeks. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Change in Number of Circulating Tumor Cells (CTC) in Response to Cabozantinib | Change in number of CTC from baseline at 12 weeks | Posted | Mean | Standard Deviation | CTCs/7.5 ml | Baseline and 12 weeks |
|
|
|
| Secondary | Number of Patients With NanoVelcro Appropriate for RNA in Circulating Tumor Cells | This is to provide a measure of feasibility using NanoVelcro to measure RNA in circulating tumor cells (CTC) | There were 16 patients evaluable for this outcome (1 patient did not have RECIST measurable disease) | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Change in Levels of Serum Hepatocyte Growth Factor (HGF) and Vascular Endothelial Growth Factor (VEGF) Concentration | Mean change from baseline in levels of HGF and VEGF | HGF was evaluable in 16 patients who had viable research samples. VEGF was evaluable in 15 patients who had viable research samples. | Posted | Mean | Standard Deviation | pg/ml | 12 weeks |
|
|
|
| Secondary | Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4) | Each cycle is 28 days. Safety and tolerability was defined as related grade 3-4 AEs of doses of cabozantinib below 100 mg daily using common terminology criteria for adverse events (CTCAE) | All patients | Posted | Count of Participants | Participants | Every 2 weeks for first 3 Cycles and every 4 weeks thereafter for an expected average of 28 weeks. |
|
|
|
| Secondary | Number of Patients With Evaluable Protein Content of Large Oncosomes From Baseline to First Documented Progression or Date of Death | This is a feasibility outcome to assess ability to measure protein content in large oncosomes in this population. | Only 12 samples were analyzed. | Posted | Count of Participants | Participants | From baseline until the date of first documented progression or date of death from any cause, whichever comes first, assessed for an expected average of 28 weeks. |
|
|
|
| 14 |
| 17 |
| 17 |
| 17 |
| Chest Pain- Cardiac | Cardiac disorders | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
|
| Confusion | Psychiatric disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Systematic Assessment |
|
| Keratitis | Eye disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Rectal fistula | Gastrointestinal disorders | Systematic Assessment |
|
| Retinal detachment | Eye disorders | Systematic Assessment |
|
| AST increased | Investigations | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Activated PTT prolonged | Investigations | Systematic Assessment |
|
| Alkaline Phosphatase increased | Investigations | Systematic Assessment |
|
| Allergic Reaction | Immune system disorders | Systematic Assessment |
|
| Allergic Rhinitis | Immune system disorders | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Anasarca | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bacterial Overgrowth | Reproductive system and breast disorders | Systematic Assessment |
|
| Blepharitis | Eye disorders | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | Systematic Assessment |
|
| Blurred Vision | Eye disorders | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Cataract | Eye disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Corneal Epithelial Defect | Eye disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Creatinine Increased | Investigations | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Diplopia | Eye disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dry eye | Eye disorders | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Dry nose | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dysguesia | Nervous system disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Edema limbs | General disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Inflamed eyelids | Eye disorders | Systematic Assessment |
|
| Eye Pain | Eye disorders | Systematic Assessment |
|
| Facial Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Fecal Incontinence | Gastrointestinal disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | Systematic Assessment |
|
| GGT Increased | Investigations | Systematic Assessment |
|
| Genital Edema | Reproductive system and breast disorders | Systematic Assessment |
|
| Gynecomastia | Reproductive system and breast disorders | Systematic Assessment |
|
| Hair Color Change | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | Systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hot Cold | General disorders | Systematic Assessment |
|
| Hot Flashes | General disorders | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Hypothyroidism | Metabolism and nutrition disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Keratitis | Eye disorders | Systematic Assessment |
|
| Lipase Increased | Investigations | Systematic Assessment |
|
| Localized edema - bilateral leg | General disorders | Systematic Assessment |
|
| Lymphocyte Count Decreased | Blood and lymphatic system disorders | Systematic Assessment |
|
| Mucositis Oral | Gastrointestinal disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nail Changes | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Nasal Discharge | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nervous system disorders other, T5 - T9 co | Nervous system disorders | Systematic Assessment |
|
| Neutrophil Count Decreased | Investigations | Systematic Assessment |
|
| Oculomotor Nerve Disorder (3rd Nervepalsy) | Nervous system disorders | Systematic Assessment |
|
| Osteonecrosis of Jaw | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Pain (Pain in Jaw) | General disorders | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Palmar-Plantar Erythrodysesthesia Syndrome | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | Systematic Assessment |
|
| Paronychia | Infections and infestations | Systematic Assessment |
|
| Platelet Count Decreased | Investigations | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Presyncope | Nervous system disorders | Systematic Assessment |
|
| Psychiatric disorders - Other, Nightmares | Psychiatric disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rectal Fistula | Gastrointestinal disorders | Systematic Assessment |
|
| Right Foot Drop | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Scalp Follicullitos | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Serum Amylase Increased | Investigations | Systematic Assessment |
|
| Sinus Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Skin Friable | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin Induration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin discoloration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Somnolence | Psychiatric disorders | Systematic Assessment |
|
| Stool Color Change | Gastrointestinal disorders | Systematic Assessment |
|
| Surgical and medical procedures- Herniorrhaphy | Gastrointestinal disorders | Systematic Assessment |
|
| TMJ | Nervous system disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Urinary Tract Obstruction | Renal and urinary disorders | Systematic Assessment |
|
| Vision Change | Eye disorders | Systematic Assessment |
|
| Voice Alteration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Vomiting (Intermittent) | Gastrointestinal disorders | Systematic Assessment |
|
| Watering Eyes | Eye disorders | Systematic Assessment |
|
| Weakness | General disorders | Systematic Assessment |
|
| Weight Loss | Investigations | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| White Blood Cell Decreased | Investigations | Systematic Assessment |
|
| hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| proteinuria | Metabolism and nutrition disorders | Systematic Assessment |
|
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Title | Measurements |
|---|---|
|
| Corneal Epithelial Defect |
|
| Dehydration |
|
| Diarrhea |
|
| GGT increased |
|
| Hematuria |
|
| Hypertension |
|
| Hyponatremia |
|
| Lipase increased |
|
| Lymphocyte count decreased |
|
| Palmar-Plantar Erythrodysesthesia |
|
| Rectal Fistula |
|