Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
Study NCT ID:
NCT01285466
Status:
COMPLETED
Last Update Posted:
2020-12-09
First Post:
2011-01-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial of Oral BEZ235 and BKM120 in Combination With Paclitaxel With or Without Trastuzumab
Sponsor:
Organization:
Raw JSON
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However, patients with a metastatic CNS lesion may participate in this trial, if the patient is \\> 4 weeks from therapy (including radiation and/or surgery) completion, clinically stable with respect to the tumor at the time of study entry, and not receiving enzyme-inducing antiepileptic drugs or corticosteroid therapy or taper, as treatment of the brain metastases\n* Patients who have received prior systemic anticancer therapy within the following time frames\n* Cyclical chemotherapy: ≤ 3 weeks before study treatment (6 weeks for patients treated with nitrosoureas)\n* Biological therapy: ≤ 4 weeks before study treatment, except treatment with trastuzumab (both parts of the trial)\n* Investigational drug: ≤ 4 weeks before study treatment\n* Patients who have undergone major surgery ≤ 4 weeks before study treatment\n* Patients receiving chronic treatment with corticosteroids or other immunosuppressive agents\n* Patients with uncontrolled, unmanageable, treatment-refractory diabetes mellitus\n* Active or history of major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, history of suicide attempt or ideation, or homicide, as judged by the investigator and/or based on recent psychiatric assessment\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01285466', 'briefTitle': 'A Trial of Oral BEZ235 and BKM120 in Combination With Paclitaxel With or Without Trastuzumab', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase Ib Multi-center, Open-label, 4-arm Dose-escalation Study of Oral BEZ235 and BKM120 in Combination With Weekly Paclitaxel in Patients With Advanced Solid Tumors and Weekly Paclitaxel/Trastuzumab in Patients With HER2+ Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'CBEZ235A2118'}, 'secondaryIdInfos': [{'id': '2010-022331-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BEZ235 + paclitaxel', 'interventionNames': ['Drug: BEZ235 + paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'BKM120 + paclitaxel', 'interventionNames': ['Drug: BKM120 + paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'BEZ235 + paclitaxel + trastuzumab', 'interventionNames': ['Drug: BEZ235 + paclitaxel + trastuzumab']}, {'type': 'EXPERIMENTAL', 'label': 'BKM120 + paclitaxel + trastuzumab', 'interventionNames': ['Drug: BKM120 + paclitaxel + trastuzumab']}], 'interventions': [{'name': 'BEZ235 + paclitaxel', 'type': 'DRUG', 'armGroupLabels': ['BEZ235 + paclitaxel']}, {'name': 'BKM120 + paclitaxel', 'type': 'DRUG', 'armGroupLabels': ['BKM120 + paclitaxel']}, {'name': 'BEZ235 + paclitaxel + trastuzumab', 'type': 'DRUG', 'armGroupLabels': ['BEZ235 + paclitaxel + trastuzumab']}, {'name': 'BKM120 + paclitaxel + trastuzumab', 'type': 'DRUG', 'armGroupLabels': ['BKM120 + paclitaxel + trastuzumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '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': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'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': '41013', 'city': 'Seville', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '7000', 'city': 'Chur', 'country': 'Switzerland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.84986, 'lon': 9.53287}}, {'zip': '9007', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}