Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-06 @ 1:21 AM
Study NCT ID:
NCT00620594
Status:
COMPLETED
Last Update Posted:
2020-12-09
First Post:
2008-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I/II Study of BEZ235 in Patients With Advanced Solid Malignancies Enriched by Patients With Advanced Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D006223', 'term': 'Hamartoma Syndrome, Multiple'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006222', 'term': 'Hamartoma'}, {'id': 'D009378', 'term': 'Neoplasms, Multiple Primary'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531198', 'term': 'dactolisib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2013-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-06', 'studyFirstSubmitDate': '2008-02-08', 'studyFirstSubmitQcDate': '2008-02-20', 'lastUpdatePostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'determine the maximum Tolerated Dose (MTD) of BEZ235 as single agent and in combination with trastuzumab (Dose escalation part)', 'timeFrame': 'at end of study'}, {'measure': 'assess the safety & tolerability of BEZ235 SDS as single agent and in combination with trastuzumab administered to patients at the MTD level (Safety expansion part)', 'timeFrame': 'at end of study'}], 'secondaryOutcomes': [{'measure': 'assess the safety and tolerability of the various formulations of BEZ235', 'timeFrame': 'at end of study'}, {'measure': 'Asses the Pharmacokinetics of BEZ235 which includes AUC, Cmax, Tmax, t1/2 as endpoints', 'timeFrame': 'at end of study'}, {'measure': 'Preliminary anti-tumor activity (tumor response) of BEZ235 SDS as single agent and in combination with trastuzumab', 'timeFrame': 'end of study'}]}, 'conditionsModule': {'keywords': ['Neoplasms', 'breast neoplasms', 'breast diseases', 'solid tumors', 'BEZ235', 'breast cancer', 'PI3K Inhibitor', 'Phosphatidylinositol 3', 'kinase', 'advanced'], 'conditions': ['Breast Cancer', 'Advanced Solid Tumors', 'Cowden Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=10543', 'label': 'Results for CBEZ235A2101 can be found on the Novartis Clinical Trial Results Website'}]}, 'descriptionModule': {'briefSummary': "This is a first-in-human, phase I/Ib clinical research study with BEZ235, an inhibitor of phosphatidylinositol 3'-kinase (PI3K). The study consists of a dose escalation part followed by a safety dose expansion part:\n\nDose escalation part (advanced solid tumors, including patients with breast cancer being treated with trastuzumab):\n\nPatients receive oral BEZ235 once daily on days 1-28 of the first course. Courses will repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nCohorts of at least 3 patients receive escalating doses of BEZ235, as single agent or in combination with trastuzumab, until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose expected to produce during the first course of treatment dose-limiting toxicity in 33% of patients.\n\nOnce the MTD has been defined, the safety expansion parts of the trial will be opened for enrollment.\n\nSafety dose expansion part (advanced solid tumors, including patients with breast cancer being treated with trastuzumab):\n\nPatients will be treated with BEZ235, as single agent or in combination with trastuzumab, given at the MTD, once daily. Treatment of patients will continue until disease progression or occurrence of unacceptable side effects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\[Single agent dose escalation arm\\]: Patients with histologically-confirmed, advanced unresectable solid tumors including CS patients who have progressed on (or not been able to tolerate) standard therapy within three months before screening visit or for whom no standard anticancer therapy exists.\n\n\\[Combination part\\]: Patients with metastatic HER2+ Breast Cancer, after failure of trastuzumab treatment. Eligible patients will have to have tumors carrying molecular alterations of PIK3CA and/or PTEN.\n\n\\[Single agent safety expansion arm\\]: Patients with histologically-confirmed, advanced unresectable solid tumors including CS patients who have progressed on (or not been able to tolerate) standard therapy within three months before screening visit or for whom no standard anticancer therapy exists. Patients will be prescreened for molecular alterations affecting PIK3CA and/or PTEN. Patients with NSCLC will also be pre-screened for EGFR mutation.\n\nExclusion Criteria:\n\n* Patients who have brain metastases, which are progressive and/or requiring medical intervention for symptom control\n* Prior treatment with a PI3K inhibitor\n* Acute or chronic liver disease or renal disease\n* Acute or chronic pancreatitis\n* Patients with unresolved diarrhea ≥ CTCAE grade 2\n* Impaired cardiac function or clinically significant cardiac diseases\n* Patients with diabetes mellitus requiring insulin treatment\n* Patients with known coagulopathies\n* Patients with a history of photosensitivity reactions to other drugs\n* Any of the following ophthalmological findings:\n* Progressive eye disease that could lead to severe loss of visual acuity or visual field\n* loss during the study period\n* Inability to perform the ophthalmic procedures required in this protocol\n* Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00620594', 'briefTitle': 'A Phase I/II Study of BEZ235 in Patients With Advanced Solid Malignancies Enriched by Patients With Advanced Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase I/II, Multi-center, Open-label Study of BEZ235, Administered Orally on a Continuous Daily Dosing Schedule in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'CBEZ235A2101'}, 'secondaryIdInfos': [{'id': '2006-004353-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BEZ235 Alone, Dose Escalation', 'interventionNames': ['Drug: BEZ235']}, {'type': 'EXPERIMENTAL', 'label': 'BEZ235 + trastuzumab, Dose Escalation', 'interventionNames': ['Drug: BEZ235']}, {'type': 'EXPERIMENTAL', 'label': 'BEZ235 Alone, MTD Expansion', 'interventionNames': ['Drug: BEZ235']}, {'type': 'EXPERIMENTAL', 'label': 'BEZ235 + Trastuzumab, MTD Expansion', 'interventionNames': ['Drug: BEZ235']}], 'interventions': [{'name': 'BEZ235', 'type': 'DRUG', 'armGroupLabels': ['BEZ235 + Trastuzumab, MTD Expansion', 'BEZ235 + trastuzumab, Dose Escalation', 'BEZ235 Alone, Dose Escalation', 'BEZ235 Alone, MTD Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Los Angeles JonssonComprehensiveCancerCtr', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine YaleCancerCtr-ClinTrialsOffice', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute Clinical Trials ProjectManager', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '89135', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Nevada Cancer Institute NVCC - Huntsman', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Cancer Centers of the Carolinas CCC Faris', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(2)', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Health Care System/Sammons Cancer Center Baylor- Sammons', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas/MD Anderson Cancer Center Thoractic Head/Neck Med.Onc(2)', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75702', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Tyler Cancer Center TCC', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '46009', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46010', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'M20 9BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}