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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00677 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| Endeavor Health | OTHER |
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This study is being done to help researchers understand more about prostate cancer that has spread to the bones by using the newest magnetic resonance imaging (MRI) techniques and to better understand the effect of an experimental drug called XL184 (or cabozantinib) on bone disease. The other purposes of the study are to better understand the effect of XL184 on prostate cancer progression, bone pain, and on any cancer cells that patients may have circulating within the blood (called circulating tumor cells)
PRIMARY OBJECTIVES:
I. To determine effect of XL184 on the functional MRI metrics Ktrans and apparent diffusion coefficient (ADC) within castrate resistant prostate cancer bone metastases.
SECONDARY OBJECTIVES:
I. To quantify progression free survival in men with castrate resistant prostate cancer (CRPC) treated with XL184 according to Prostate Cancer Working Group criteria.
II. To correlate and changes in MRI based functional metrics with bone scan, prostate specific antigen (PSA), Response Evaluation Criteria in Solid Tumors (RECIST) response criteria, circulating tumor cells (CTC) number and with changes in pain.
III. To explore c-MET, phospho-c-MET staining on circulating tumor cells as a predictive biomarker for response and duration of response to XL-184.
OUTLINE:
Patients receive cabozantinib orally (PO) once daily (QD). Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (enzyme inhibitor therapy) | Experimental | Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cabozantinib | Drug | Given PO |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in the Functional MRI Metrics Ktrans Between 2 Weeks and Baseline | Ktrans is a measurement calculating the volume transfer constant of the contrast reagent and essentially is a measurement of vascular perfusion. To determine the effect of XL184 on the functional MRI metrics Ktrans, Ktrans parameters were measured at baseline, two week time-point, 12 weeks, and 24 weeks for disease monitoring. Change between baseline and 2 weeks reported. | baseline, 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Association of Progression Free Survival (PFS) With Ktrans and ADC | Time to progression or progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. The approximate survival after standard therapies in this setting is bleak and in the order of months. Too few events for a meaningful statistical analysis; no significant results were obtained in Cox regression analyses. Therefore, we calculated the median PFS time and its 95% confidence interval. |
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Inclusion Criteria:
Histologically or cytologically confirmed prostate cancer with progressive disease
Evidence of castration resistance defined as disease progression despite a testosterone level < 50ng/dL (or surgical castration)
Evidence of metastatic disease to the bones within the lumbar spine, sacrum, or pelvic bones that is identifiable on screening pelvic MRI
If patient has had prior pelvis radiation therapy (RT), then bone metastases must be out of radiated port (e.g. lumbar or sacral spine)
Any prior therapy for castrate disease acceptable other than prior XL184 with a minimum washout of 28 days for any other anticancer therapy
Patients with castrate resistant disease post antiandrogen therapy/withdrawal must meet at least one of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Russell Szmulewitz | University of Chicago Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637-1470 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Enzyme Inhibitor Therapy) | Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity. cabozantinib: Given PO laboratory biomarker analysis: Correlative studies magnetic resonance imaging: Undergo MRI |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Aug 13, 2013 |
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| laboratory biomarker analysis | Other | Correlative studies |
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| magnetic resonance imaging | Procedure | Undergo MRI |
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| From start of treatment to time of progression or death, whichever occurs first, assessed up to 1 year |
| Changes in Bone Scan Response | Bone Scan Response at weeks 2, 12, and 24 were collected. Change between baseline and 2 weeks are reported Bone Scan Response were measured as increase, decrease, or stable of bone lesions and scored as 1, -1, or 0, respectively, where higher values represent a worse outcome. | baseline, 2 weeks |
| Correlation of Percent Change in the Functional MRI Metrics to RECIST Tumor Measurements | The protocol proposed to collect RECIST tumor measurements at weeks 0, 12, and 24. However, the data were not collected | baseline, 12 weeks, and 24 weeks |
| Change of PSA Between 12 Weeks and Baseline | PSA at weeks 0, 12, and 24 were collected. Change between baseline and 12 weeks are reported | baseline, 12 weeks |
| Correlation of Percent Change in the Functional MRI Metrics With CTC | The protocol proposed to collect CTC measurements at weeks 0, 12, and 24. However, the data were not collected | baseline, 12 weeks, and 24 weeks |
| Change in Pain Scale Between 12 Weeks and Baseline | Pain scores are measured at baseline and weeks 12, and 24. Change between baseline and 12 weeks are reported . In the pain score ranged from 0 to 10. 10 denotes most pain. | baseline,12 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Enzyme Inhibitor Therapy) | Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity. cabozantinib: Given PO laboratory biomarker analysis: Correlative studies magnetic resonance imaging: Undergo MRI |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in the Functional MRI Metrics Ktrans Between 2 Weeks and Baseline | Ktrans is a measurement calculating the volume transfer constant of the contrast reagent and essentially is a measurement of vascular perfusion. To determine the effect of XL184 on the functional MRI metrics Ktrans, Ktrans parameters were measured at baseline, two week time-point, 12 weeks, and 24 weeks for disease monitoring. Change between baseline and 2 weeks reported. | 2 individuals had missing values for Ktrans from baseline to 24 weeks | Posted | Least Squares Mean | Standard Deviation | per minute (or min-1) | baseline, 2 weeks |
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| Secondary | Association of Progression Free Survival (PFS) With Ktrans and ADC | Time to progression or progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. The approximate survival after standard therapies in this setting is bleak and in the order of months. Too few events for a meaningful statistical analysis; no significant results were obtained in Cox regression analyses. Therefore, we calculated the median PFS time and its 95% confidence interval. | Posted | Median | 95% Confidence Interval | month | From start of treatment to time of progression or death, whichever occurs first, assessed up to 1 year |
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| Secondary | Changes in Bone Scan Response | Bone Scan Response at weeks 2, 12, and 24 were collected. Change between baseline and 2 weeks are reported Bone Scan Response were measured as increase, decrease, or stable of bone lesions and scored as 1, -1, or 0, respectively, where higher values represent a worse outcome. | 6 individual have missing bone lesions data. | Posted | Mean | Standard Deviation | score on a scale | baseline, 2 weeks |
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| Secondary | Correlation of Percent Change in the Functional MRI Metrics to RECIST Tumor Measurements | The protocol proposed to collect RECIST tumor measurements at weeks 0, 12, and 24. However, the data were not collected | Data on RECIST tumor measurements were not collected | Posted | baseline, 12 weeks, and 24 weeks |
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| Secondary | Change of PSA Between 12 Weeks and Baseline | PSA at weeks 0, 12, and 24 were collected. Change between baseline and 12 weeks are reported | At 12 weeks, 4 individual have missing PSA data. | Posted | Mean | Standard Deviation | ng/mL | baseline, 12 weeks |
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| Secondary | Correlation of Percent Change in the Functional MRI Metrics With CTC | The protocol proposed to collect CTC measurements at weeks 0, 12, and 24. However, the data were not collected | data on CTC were not collected | Posted | baseline, 12 weeks, and 24 weeks |
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| Secondary | Change in Pain Scale Between 12 Weeks and Baseline | Pain scores are measured at baseline and weeks 12, and 24. Change between baseline and 12 weeks are reported . In the pain score ranged from 0 to 10. 10 denotes most pain. | At 12 weeks, 3 individual have missing pain score data. | Posted | Mean | Standard Deviation | score on a scale | baseline,12 weeks |
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Adverse events were monitored/assessed every two weeks for the first three months and then every 4 weeks thereafter (until one year).
Assessment of toxicities and adverse events were graded according to the Common Toxicity Criteria (CTC), version 4.03.
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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 | Treatment (Enzyme Inhibitor Therapy) | Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity. cabozantinib: Given PO laboratory biomarker analysis: Correlative studies magnetic resonance imaging: Undergo MRI | 1 | 17 | 4 | 17 | 15 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophil count decreased | Blood and lymphatic system disorders | V4.03 (CTCAE) | Non-systematic Assessment |
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| hospitalized with pneumaonia (Aspiration) | Respiratory, thoracic and mediastinal disorders | V4.03 (CTCAE) | Non-systematic Assessment |
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| Dehydration | General disorders | V4.03 (CTCAE) | Non-systematic Assessment |
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| Syncope | Blood and lymphatic system disorders | V4.03 (CTCAE) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | V4.03 (CTCAE) | Non-systematic Assessment |
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| mucositis | Gastrointestinal disorders | V4.03 (CTCAE) | Non-systematic Assessment |
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| diarrhea | Gastrointestinal disorders | V4.03 (CTCAE) | Non-systematic Assessment |
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| plantar erythrodysaesthesia | Skin and subcutaneous tissue disorders | V4.03 (CTCAE) | Non-systematic Assessment |
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| elevated transaminases | Gastrointestinal disorders | V4.03 (CTCAE) | Non-systematic Assessment |
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| decreased appetite | Gastrointestinal disorders | V4.03 (CTCAE) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Russell Szmulewitz, MD | University of Chicago | 773-702-7609 | rszmulew@medicine.bsd.uchicago.edu |
| Jan 31, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C558660 | cabozantinib |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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