Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-31 @ 10:11 PM
Study NCT ID:
NCT01995058
Status:
TERMINATED
Last Update Posted:
2015-02-20
First Post:
2013-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Cabozantinib in Combination With Abiraterone in Chemotherapy-Naïve Subjects With Bone-Metastatic Castration-Resistant Prostate Cancer
Sponsor:
Organization:
Raw JSON
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'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C558660', 'term': 'cabozantinib'}, {'id': 'C089740', 'term': 'abiraterone'}, {'id': 'D000069501', 'term': 'Abiraterone Acetate'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'whyStopped': 'Study stopped after results of cabozantinib Phase 3 CRPC study XL184-307.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-19', 'studyFirstSubmitDate': '2013-11-14', 'studyFirstSubmitQcDate': '2013-11-21', 'lastUpdatePostDateStruct': {'date': '2015-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety and tolerability as assessed by adverse events', 'timeFrame': 'Up to 18 months', 'description': 'Subjects are followed for safety as assessed by adverse events at least through 30 days after the date of a decision to permanently discontinue study treatment.'}, {'measure': 'Pharmacokinetic Pre-dose Plasma Concentrations of both cabozantinib and abiraterone when administered in combination', 'timeFrame': 'Days 1-4, Week 3, Week 5, Week 7, Week 9, Week 17, and Week 41', 'description': 'When administered in combination, both cabozantinib and abiraterone plasma concentrations will be measured prior to dosing on selected visits'}, {'measure': 'Overall survival', 'timeFrame': 'Up to 36 months', 'description': 'Overall survival is defined as the time from randomization to death from any cause.'}, {'measure': 'Bone scan response by computer-aided detection (CAD)', 'timeFrame': 'Up to 18 months', 'description': 'Bone scans will be evaluated by an independent radiology facility for response'}, {'measure': 'Pharmacokinetic Plasma Area Under the Curve (AUC)', 'timeFrame': 'Week 5', 'description': 'For selected subjects, the plasma AUC of cabozantinib and abiraterone will be measured at Week 5'}], 'primaryOutcomes': [{'measure': 'Radiographic progression free survival (PFS)', 'timeFrame': 'Up to 18 months', 'description': 'PFS is defined as the time from randomization to the earlier of the following events: disease progression or death due to any cause'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CRPC', 'castration resistant prostate cancer', 'prostate cancer'], 'conditions': ['Prostate Cancer', 'Castration Resistant Prostate Cancer', 'Prostatic Neoplasms']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the safety and efficacy of combining abiraterone (with prednisone) with cabozantinib in chemotherapy-naïve subjects with bone-metastatic castration-resistant prostate cancer (CRPC).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the prostate.\n* Must be surgically or medically castrated (serum testosterone levels less than or equal to 50 ng/dL)\n* Must have castration-resistant prostate cancer (CRPC) with disease progression during LHRH therapy or after a surgical bilateral orchiectomy.\n* Bone metastasis related to prostate cancer\n* Adequate organ and marrow function\n* Capable of understanding and complying with the protocol requirements and signed the informed consent document\n* Sexually active subjects and their partners must agree to use medically accepted methods of barrier contraception (eg, male condom or female condom) as well as one other medically accepted method of contraception during the course of the study treatment and for 4 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Any prior treatment with abiraterone, enzalutamide, or any investigational agents blocking androgen receptor (AR) or androgen synthesis.\n* Any prior treatment with cabozantinib or participation in a prior clinical trial of cabozantinib.\n* Any prior cytotoxic therapy (including estramustine) or biologic therapy for the treatment of prostate cancer (a few exceptions will be allowed)\n* Any prior radionuclide therapy (eg, samarium 153, strontium 89, alpharadin)\n* Use of investigational agent within 28 days\n* Any pathological finding consistent with small cell carcinoma of the prostate\n* Known brain metastases or cranial epidural disease\n* Diagnosis of another malignancy within 2 years, except for superficial non-melanoma skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy'}, 'identificationModule': {'nctId': 'NCT01995058', 'briefTitle': 'Study of Cabozantinib in Combination With Abiraterone in Chemotherapy-Naïve Subjects With Bone-Metastatic Castration-Resistant Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Exelixis'}, 'officialTitle': 'A Randomized Phase 2 Study of Cabozantinib (XL184) in Combination With Abiraterone in Chemotherapy Naïve Subjects With Bone-Metastatic Castration-Resistant Prostate Cancer', 'orgStudyIdInfo': {'id': 'XL184-210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cabozantinib arm 1', 'description': 'Subjects randomized to this arm will receive cabozantinb 40 mg daily with abiratarone and prednisone', 'interventionNames': ['Drug: cabozantinib', 'Drug: abiraterone', 'Drug: prednisone']}, {'type': 'EXPERIMENTAL', 'label': 'Cabozantinib arm 2', 'description': 'Subjects randomized to this arm will receive cabozantinib 20 mg daily with abiraterone and prednisone', 'interventionNames': ['Drug: cabozantinib', 'Drug: abiraterone', 'Drug: prednisone']}, {'type': 'EXPERIMENTAL', 'label': 'Cabozantinib arm 3', 'description': 'Subjects randomized to this arm will receive cabozantinb 20 mg every other day with abiraterone and prednisone', 'interventionNames': ['Drug: cabozantinib', 'Drug: abiraterone', 'Drug: prednisone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Abiraterone only arm (4)', 'description': 'Subjects randomized to this arm will receive abiraterone with prednisone only', 'interventionNames': ['Drug: abiraterone', 'Drug: prednisone']}], 'interventions': [{'name': 'cabozantinib', 'type': 'DRUG', 'otherNames': ['XL184'], 'description': 'Tablets taken orally', 'armGroupLabels': ['Cabozantinib arm 1', 'Cabozantinib arm 2', 'Cabozantinib arm 3']}, {'name': 'abiraterone', 'type': 'DRUG', 'otherNames': ['Zytiga(R)', 'abiraterone acetate'], 'description': 'Tablets taken orally daily', 'armGroupLabels': ['Abiraterone only arm (4)', 'Cabozantinib arm 1', 'Cabozantinib arm 2', 'Cabozantinib arm 3']}, {'name': 'prednisone', 'type': 'DRUG', 'description': 'Tablets taken orally twice daily', 'armGroupLabels': ['Abiraterone only arm (4)', 'Cabozantinib arm 1', 'Cabozantinib arm 2', 'Cabozantinib arm 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': 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'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '61615', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '89148', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '97062', 'city': 'Tualatin', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.38401, 'lon': -122.76399}}, {'zip': '29414', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29572', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77024', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Exelixis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-10-13', 'type': 'RELEASE'}, {'date': '2023-11-07', 'type': 'RESET'}, {'date': '2023-12-02', 'type': 'RELEASE'}, {'date': '2023-12-21', 'type': 'RESET'}, {'date': '2024-02-07', 'type': 'RELEASE'}, {'date': '2024-03-05', 'type': 'RESET'}, {'date': '2024-03-29', 'type': 'RELEASE'}, {'date': '2024-04-24', 'type': 'RESET'}, {'date': '2024-06-10', 'type': 'RELEASE'}, {'date': '2024-07-01', 'type': 'RESET'}, {'date': '2025-11-12', 'type': 'RELEASE'}, {'date': '2025-11-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Exelixis'}}}}