Multiparametric Assessment of Bone Response in mCRPC Patients Treated With Cabozantinib
NCT ID: NCT05265988
Last Updated: 2024-07-31
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
32 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-11-29
Study Completion Date
2024-06-29
Brief Summary
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Multiparametric assesment of bone response in mCRPC patients treated with Cabozantinib upon progression to chemotherapy and next generation hormonal agents: a phase II study
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Detailed Description
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This is a monocentric, single arm, prospective clinical trial designed to obtain explorative information about the effect of Cabozantinib on bone in prostate cancer patients with bone metastatic castration resistant disease, previously treated with two taxanes and at least one next generation hormonal agent.
Activity of bone metastatic disease will be assessed by WB-DW-MRI, while changes in bone metabolism will be studied through DXA scan and soluble biomarkers
Activity of bone metastatic disease will be assessed by WB-DW-MRI, while changes in bone metabolism will be studied through DXA scan and soluble biomarkers
Conditions
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Carcinoma Prostate
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Monocentrici Study. The patients are treated in one arm
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
The patients are treated in one arm.
Study Groups
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Meridian
Cabozantinib at initial dosage of 40 mg per day and continuation of androgen deprivation therapy
Group Type
EXPERIMENTAL
Cabozantinib
Intervention Type
DRUG
Cabozantinib at initial dosage of 40 mg per day and continuation of androgen deprivation therapy
Interventions
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Cabozantinib
Cabozantinib at initial dosage of 40 mg per day and continuation of androgen deprivation therapy
Intervention Type
DRUG
Other Intervention Names
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Cabozantinib 40/20 mg tablet
Eligibility Criteria
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Inclusion Criteria
* Histological diagnosis of prostate carcinoma,
* Age \> 18 years,
* Metastatic disease documented as the presence of bone lesions o bone scan associated or not to soft tissue lesions measurable at CT/RMN,
* Eastern Cooperative Oncology Group (ECOG) performance status equal or less than 2
* Expected life expectancy ≥ 3 months,
* Patients who have already received docetaxel, cabazitaxel and at least one next generation hormonal agent (abiraterone or enzalutamide) for metastatic disease (either hormone sensitive or castration resistant),
* Subject capable to swallow the Study's medication and to comply with the Study's requirements,
* Fertile patients and their partners must agree to use methods of contraception.
* Signed informed consent.
* Age \> 18 years,
* Metastatic disease documented as the presence of bone lesions o bone scan associated or not to soft tissue lesions measurable at CT/RMN,
* Eastern Cooperative Oncology Group (ECOG) performance status equal or less than 2
* Expected life expectancy ≥ 3 months,
* Patients who have already received docetaxel, cabazitaxel and at least one next generation hormonal agent (abiraterone or enzalutamide) for metastatic disease (either hormone sensitive or castration resistant),
* Subject capable to swallow the Study's medication and to comply with the Study's requirements,
* Fertile patients and their partners must agree to use methods of contraception.
* Signed informed consent.
Exclusion Criteria
* Presence of active serious disease, active infection or co-comorbidity that may prevent the study enrollment make (at the discretion of the clinical Investigator),
* Known or suspected brain metastases or active leptomeningeal dissemination,
* History of other malignant neoplasm during the previous 5 years, different from the non-melanoma skin carcinoma,
* Absolute Neutrophil Count (ANC) \< 1.500/µL, platelet \< 100.000/µL, or hemoglobin \< 5,6 mmol/L (\< 9 g/dL) at Screening Visit (notably: patients must not receive neither any growth factor during the previous 7 days nor any blood transfusion during the 28 days preceding the hematology sampling performed at Screening),
* Total bilirubin \> 1,5 x ULN at Screening Visit,
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2,5 x ULN at Screening Visit,
* Creatinine \> 177 µmol/L (\> 2 mg/dL) at Screening Visit,
* Albumin ≤ 30 g/L (≤ 3,0 g/dL) at Screening Visit,
* Alkaline Phosphatase ≥ 5 x ULN,
* Prothrombin time / international normalized ratio (PT/INR) or partial thromboplastin time (PTT) test ≥ 1.3 x the laboratory ULN,
* Urine protein-to-creatinine ratio (UPCR) \> 1 mg/mg (or 113.0 mg/mmol) or proteinuria \> 1 g/24 h,
* History of seizures or any other seizure-predisposed pathology; history of loss of consciousness or transitory ischaemic attack during the 12 months preceding the Screening visit,
* Clinically significant cardiovascular disease including:
* Myocardial infarction (6 months preceding the screening),
* Uncontrolled angina (3 months preceding the screening),
* Congestive heart failure New York Heart Association (NYHA) class 3 or 4, congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan performed within three months results in a left ventricular ejection fraction that is ≥ 45%,
* History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes),
* History of long QT syndrome or corrected QT interval calculated by the Fridericia formula \> 500 msec at Screening Visit,
* History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place,
* Hypotension as indicated by systolic blood pressure \< 86 millimeters of mercury (mmHg) at the Screening visit,
* Bradycardia as indicated by a heart rate of \< 50 beats per minute on the Screening ECG,
* Uncontrolled hypertension as indicated by systolic blood pressure \> 170 mmHg or diastolic blood pressure \> 105 mmHg at the Screening visit,
* History of thromboembolic events, including pulmonary embolism or untreated deep venous thrombosis (6 months preceding the screening)
* Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last 3 months),
* Major surgery within 8 weeks of enrollment (Day 1 Visit). Complete healing from major surgery must have occurred 4 weeks before enrollment. Complete healing from minor surgery (e.g. simple excision, tooth extraction) must have occurred at least 7 days before enrollment.
* Subjects with clinically relevant complications from prior surgery.
* Concomitant therapy with anticoagulants such as warfarin or warfarin-related agents, thrombin or coagulation factor X (FXa) inhibitors, or antiplatelet agents (e.g. clopidogrel). Low molecular weight Heparin (LMWH) and low-dose aspirin for cardioprotection (per local applicable guidelines) are permitted.
* Concomitant use of strong inhibitors of CYP3A4 (including, but not limiting to: ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, and ritonavir).
* Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within 4 weeks of enrollment (Day 1 visit).
* Previously identified allergy or hypersensitivity to the study drug and/or excipients.
* Bone antiresorptive drugs (e.g., zoledronic acid or denosumab) that are started within 4 weeks of enrollment (Day 1 Visit). Bone antiresorptive drugs are permitted if already ongoing before this time point. Patients will be stratified according to zoledronic acid/denosumab exposure.
* Systemic treatment with radionuclides within 6 weeks before first dose of study treatment or radiotherapy on sites other than bone administrated within 4 weeks of enrollment (Day 1 Visit). Radiotherapy on bone administrated within 2 weeks of enrollment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible. Radiotherapy given with palliative intent will be permitted during study treatment.
* Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data.
* Known or suspected brain metastases or active leptomeningeal dissemination,
* History of other malignant neoplasm during the previous 5 years, different from the non-melanoma skin carcinoma,
* Absolute Neutrophil Count (ANC) \< 1.500/µL, platelet \< 100.000/µL, or hemoglobin \< 5,6 mmol/L (\< 9 g/dL) at Screening Visit (notably: patients must not receive neither any growth factor during the previous 7 days nor any blood transfusion during the 28 days preceding the hematology sampling performed at Screening),
* Total bilirubin \> 1,5 x ULN at Screening Visit,
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2,5 x ULN at Screening Visit,
* Creatinine \> 177 µmol/L (\> 2 mg/dL) at Screening Visit,
* Albumin ≤ 30 g/L (≤ 3,0 g/dL) at Screening Visit,
* Alkaline Phosphatase ≥ 5 x ULN,
* Prothrombin time / international normalized ratio (PT/INR) or partial thromboplastin time (PTT) test ≥ 1.3 x the laboratory ULN,
* Urine protein-to-creatinine ratio (UPCR) \> 1 mg/mg (or 113.0 mg/mmol) or proteinuria \> 1 g/24 h,
* History of seizures or any other seizure-predisposed pathology; history of loss of consciousness or transitory ischaemic attack during the 12 months preceding the Screening visit,
* Clinically significant cardiovascular disease including:
* Myocardial infarction (6 months preceding the screening),
* Uncontrolled angina (3 months preceding the screening),
* Congestive heart failure New York Heart Association (NYHA) class 3 or 4, congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan performed within three months results in a left ventricular ejection fraction that is ≥ 45%,
* History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes),
* History of long QT syndrome or corrected QT interval calculated by the Fridericia formula \> 500 msec at Screening Visit,
* History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place,
* Hypotension as indicated by systolic blood pressure \< 86 millimeters of mercury (mmHg) at the Screening visit,
* Bradycardia as indicated by a heart rate of \< 50 beats per minute on the Screening ECG,
* Uncontrolled hypertension as indicated by systolic blood pressure \> 170 mmHg or diastolic blood pressure \> 105 mmHg at the Screening visit,
* History of thromboembolic events, including pulmonary embolism or untreated deep venous thrombosis (6 months preceding the screening)
* Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last 3 months),
* Major surgery within 8 weeks of enrollment (Day 1 Visit). Complete healing from major surgery must have occurred 4 weeks before enrollment. Complete healing from minor surgery (e.g. simple excision, tooth extraction) must have occurred at least 7 days before enrollment.
* Subjects with clinically relevant complications from prior surgery.
* Concomitant therapy with anticoagulants such as warfarin or warfarin-related agents, thrombin or coagulation factor X (FXa) inhibitors, or antiplatelet agents (e.g. clopidogrel). Low molecular weight Heparin (LMWH) and low-dose aspirin for cardioprotection (per local applicable guidelines) are permitted.
* Concomitant use of strong inhibitors of CYP3A4 (including, but not limiting to: ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, and ritonavir).
* Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within 4 weeks of enrollment (Day 1 visit).
* Previously identified allergy or hypersensitivity to the study drug and/or excipients.
* Bone antiresorptive drugs (e.g., zoledronic acid or denosumab) that are started within 4 weeks of enrollment (Day 1 Visit). Bone antiresorptive drugs are permitted if already ongoing before this time point. Patients will be stratified according to zoledronic acid/denosumab exposure.
* Systemic treatment with radionuclides within 6 weeks before first dose of study treatment or radiotherapy on sites other than bone administrated within 4 weeks of enrollment (Day 1 Visit). Radiotherapy on bone administrated within 2 weeks of enrollment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible. Radiotherapy given with palliative intent will be permitted during study treatment.
* Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data.
Eligible Sex
MALE
Accepts Healthy Volunteers
Yes
Sponsors
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Alfredo Berruti
OTHER
Sponsor Role
lead
Responsible Party
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Alfredo Berruti
Director of the Medical Oncology Unit
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Alfredo Berruti
Role: PRINCIPAL_INVESTIGATOR
Asst Degli Spedali Civili Di Brescia
Locations
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Alfredo Berruti
Brescia, , Italy
Site Status
Countries
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Italy
References
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Shiozawa Y, Pedersen EA, Havens AM, Jung Y, Mishra A, Joseph J, Kim JK, Patel LR, Ying C, Ziegler AM, Pienta MJ, Song J, Wang J, Loberg RD, Krebsbach PH, Pienta KJ, Taichman RS. Human prostate cancer metastases target the hematopoietic stem cell niche to establish footholds in mouse bone marrow. J Clin Invest. 2011 Apr;121(4):1298-312. doi: 10.1172/JCI43414. Epub 2011 Mar 23.
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Smith M, De Bono J, Sternberg C, Le Moulec S, Oudard S, De Giorgi U, Krainer M, Bergman A, Hoelzer W, De Wit R, Bogemann M, Saad F, Cruciani G, Thiery-Vuillemin A, Feyerabend S, Miller K, Houede N, Hussain S, Lam E, Polikoff J, Stenzl A, Mainwaring P, Ramies D, Hessel C, Weitzman A, Fizazi K. Phase III Study of Cabozantinib in Previously Treated Metastatic Castration-Resistant Prostate Cancer: COMET-1. J Clin Oncol. 2016 Sep 1;34(25):3005-13. doi: 10.1200/JCO.2015.65.5597. Epub 2016 Jul 11.
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Vanel D, Casadei R, Alberghini M, Razgallah M, Busacca M, Albisinni U. MR imaging of bone metastases and choice of sequence: spin echo, in-phase gradient echo, diffusion, and contrast medium. Semin Musculoskelet Radiol. 2009 Jun;13(2):97-103. doi: 10.1055/s-0029-1220880. Epub 2009 May 19.
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Padhani AR, Makris A, Gall P, Collins DJ, Tunariu N, de Bono JS. Therapy monitoring of skeletal metastases with whole-body diffusion MRI. J Magn Reson Imaging. 2014 May;39(5):1049-78. doi: 10.1002/jmri.24548. Epub 2014 Feb 10.
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Huang W, Li X, Chen Y, Li X, Chang MC, Oborski MJ, Malyarenko DI, Muzi M, Jajamovich GH, Fedorov A, Tudorica A, Gupta SN, Laymon CM, Marro KI, Dyvorne HA, Miller JV, Barbodiak DP, Chenevert TL, Yankeelov TE, Mountz JM, Kinahan PE, Kikinis R, Taouli B, Fennessy F, Kalpathy-Cramer J. Variations of dynamic contrast-enhanced magnetic resonance imaging in evaluation of breast cancer therapy response: a multicenter data analysis challenge. Transl Oncol. 2014 Feb 1;7(1):153-66. doi: 10.1593/tlo.13838. eCollection 2014 Feb.
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Senn C, Gunther B, Popp AW, Perrelet R, Hans D, Lippuner K. Comparative effects of teriparatide and ibandronate on spine bone mineral density (BMD) and microarchitecture (TBS) in postmenopausal women with osteoporosis: a 2-year open-label study. Osteoporos Int. 2014 Jul;25(7):1945-51. doi: 10.1007/s00198-014-2703-8. Epub 2014 Apr 24.
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Other Identifiers
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ASSTBS-FARM-ONC-MERIDIAN-2020
Identifier Type: -
Identifier Source: org_study_id
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