Ignite Creation Date:
2025-12-24 @ 12:57 PM
Ignite Modification Date:
2025-12-29 @ 2:28 AM
Study NCT ID:
NCT01634061
Status:
COMPLETED
Last Update Posted:
2020-12-09
First Post:
2012-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase Ib of Abiraterone Acetate Plus BEZ235 or BKM120 in Castration-resistant Prostate Cancer (CRPC) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark', 'Germany', 'Italy', 'Switzerland']}, 'interventionBrowseModule': {'meshes': [{'id': 'C531198', 'term': 'dactolisib'}, {'id': 'C571178', 'term': 'NVP-BKM120'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-06', 'studyFirstSubmitDate': '2012-06-26', 'studyFirstSubmitQcDate': '2012-07-02', 'lastUpdatePostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dose limiting toxicities (DLTs)', 'timeFrame': 'from days 1-35 in BEZ235/abiraterone acetate arm and from days 1-28 in BKM120/abiraterone acetate arm', 'description': 'Dose escalation part: Determine MTD and /or RDE of the combinations abiraterone acetate + BEZ235 and abiraterone acetate + BKM120 by assessing the incidence of DLTs in cycle 1'}, {'measure': 'Prostate specific antigen (PSA) decline ≥ 30%', 'timeFrame': 'At week 12 or later after treatment discontinuation', 'description': 'Dose expansion part: Assess anti-tumor activity of the combinations (abiraterone acetate + BEZ235 and abiraterone acetate + BKM120) in castration-resistant prostate cancer patients with abiraterone acetate failure as on treatment PSA progression according to prostate cancer working group criteria 2 (PCWG2) by assessing PSA decline ≥ 30% at Week 12 or later.'}], 'secondaryOutcomes': [{'measure': 'Number of patients with at least one adverse event', 'timeFrame': 'Treatment start until 30 days after the last dose'}, {'measure': 'radiological Progression Free Survival as per RECIST 1.1 and PCWG2', 'timeFrame': 'Every 12 weeks until disease progression'}, {'measure': 'radiological Response Rate according to RECIST 1.1', 'timeFrame': 'Every 12 weeks until disease progression'}, {'measure': 'Overall Survival', 'timeFrame': 'From treatment start until 75% of deaths from any cause have occurred'}, {'measure': 'Number and percentage of patients with laboratory abnormalities', 'timeFrame': 'Treatment start until 30 days after the last dose'}, {'measure': 'Changes in ECG (electrocardiogram)', 'timeFrame': 'Treatment start until 30 days after the last dose'}, {'measure': 'Changes in vital signs', 'timeFrame': 'Treatment start until 30 days after the last dose'}, {'measure': 'Changes in mood scales', 'timeFrame': 'Treatment start until 30 days after the last dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Castration-resistant prostate cancer, abiraterone acetate, BEZ235, BKM120, dose escalation, abiraterone acetate failure'], 'conditions': ['Castration-resistant Prostate Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=15047', 'label': 'Results for CBEZ235D2101 can be found on the Novartis Clinical Trial Results Website'}]}, 'descriptionModule': {'briefSummary': 'This is an open label study of abiraterone acetate in combination with BEZ235 and abiraterone acetate in combination with BKM120 in CRPC patients with abiraterone acetate failure.', 'detailedDescription': 'A dose-escalation part will first determine the maximum tolerated dose (MTD) and/or recomended dose for expansion (RDE) of abiraterone acetate in combination with BEZ235 and abiraterone acetate in combination with BKM120 in CRPC patients with abiraterone acetate failure.\n\nSubsequently, the MTD and/or RDE of each combination will be investigated in two expansion treatment groups of CRPC patients who have failed abiraterone acetate therapy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult males ≥ 18 years old\n* Eastern Cooperative Oncology Group Performance Status ≤ 2\n* Patient must have a castrate level of testosterone (\\<= 50 ng/dL or 1.7 nmol/L). ( Castrate status must be maintained by continued GnRH analogues unless patient has undergone surgical orchiectomy).\n* Histologically or cytologically confirmed diagnosis of advanced or metastatic prostate cancer.\n* Advanced or metastatic castration-resistant prostate cancer progression after abiraterone acetate failure\n* Patients should have no more than 2 lines of prior chemotherapies including cytotoxic agents\n* Discontinuation of all anti-androgen, anti-neoplastic or investigational treatment \\>= 4 weeks (6 weeks for bicalutamide).\n\nExclusion Criteria:\n\n* Previous treatment with PI3K pathway inhibitors (e.g. PI3K, AKT, mTOR inhibitor), ketoconazole, CYP17 inhibitors (exception of AA), or enzalutamide.\n* Patient has active uncontrolled or symptomatic CNS metastases\n* Inadequately controlled hypertension (e.g. systolic blood pressure \\>=160 mmHg or diastolic blood pressure \\>=95 mmHg)\n* Patient has a QTcF \\> 480 msec on the screening ECG (using the QTcF formula), has a short/long QT syndrome, or history of QT prolongation/Torsades de Pointes\n* Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drugs\n* Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others)\n* Patients who experienced dose reductions and/or treatment interruptions due to abiraterone acetate related toxicities (i.e. serious AEs, AEs, liver toxicities during abiraterone acetate treatment'}, 'identificationModule': {'nctId': 'NCT01634061', 'briefTitle': 'Phase Ib of Abiraterone Acetate Plus BEZ235 or BKM120 in Castration-resistant Prostate Cancer (CRPC) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Phase Ib Dose Finding Study of Abiraterone Acetate Plus BEZ235 or BKM120 in Patients With Castration-resistant Prostate Cancer.', 'orgStudyIdInfo': {'id': 'CBEZ235D2101'}, 'secondaryIdInfos': [{'id': '2012-002250-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose escalation: BEZ235 + Zytiga®', 'description': 'BEZ235 oral twice daily: 200 mg, 300 mg, and 400 mg dose levels to be tested in the dose escalation part in combination with abiraterone acetate Zytiga® abiraterone acetate oral once daily: 1000 mg taken with low dose prednisone as per the label', 'interventionNames': ['Drug: BEZ235']}, {'type': 'EXPERIMENTAL', 'label': 'Dose escalation: BKM120 + Zytiga®', 'description': 'BKM120 oral once daily: 60 mg, 80 mg and 100 mg dose levels to be tested in the dose escalation part in combination with abiraterone acetate Zytiga® abiraterone acetate oral once daily: 1000 mg taken with low dose prednisone as per the label', 'interventionNames': ['Drug: BKM120']}, {'type': 'EXPERIMENTAL', 'label': 'Dose expansion: BEZ235 + Zytiga®', 'description': 'BEZ235 oral twice daily: 200 mg, 300 mg, and 400 mg dose levels to be tested in the dose escalation part in combination with abiraterone acetate\n\nZytiga® abiraterone acetate oral once daily: 1000 mg taken with low dose prednisone as per the label', 'interventionNames': ['Drug: BEZ235']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion: BKM120 + Zytiga®', 'description': 'BKM120 oral once daily: 60 mg, 80 mg and 100 mg dose levels to be tested in the dose escalation part in combination with abiraterone acetate Zytiga® abiraterone acetate oral once daily: 1000 mg taken with low dose prednisone as per the label', 'interventionNames': ['Drug: BKM120']}], 'interventions': [{'name': 'BEZ235', 'type': 'DRUG', 'description': "BEZ235 will be supplied as 50mg, 100mg, 200mg, 300mg and 400mg SDS sachets. At each patient's visit, patient will reecive a prescription of an adequate drug supply for self administration at home.", 'armGroupLabels': ['Dose escalation: BEZ235 + Zytiga®']}, {'name': 'BKM120', 'type': 'DRUG', 'description': "BKM120 will be supplied as 10mg and 50mg hard gelatin capsules. At each patient's visit, patient will reecive a prescription of an adequate drug supply for self administration at home.", 'armGroupLabels': ['Dose escalation: BKM120 + Zytiga®']}, {'name': 'BEZ235', 'type': 'DRUG', 'description': "BEZ235 will be supplied as 50mg, 100mg, 200mg, 300mg and 400mg SDS sachets. At each patient's visit, patient will reecive a prescription of an adequate drug supply for self administration at home.", 'armGroupLabels': ['Dose expansion: BEZ235 + Zytiga®']}, {'name': 'BKM120', 'type': 'DRUG', 'description': "BKM120 will be supplied as 10mg and 50mg hard gelatin capsules. At each patient's visit, patient will reecive a prescription of an adequate drug supply for self administration at home.", 'armGroupLabels': ['Dose Expansion: BKM120 + Zytiga®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center SC', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center Hackensack Univ', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': 'BE-B-1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '2610', 'city': 'Wilrijk', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': '13273', 'city': 'Marseille', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}