[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100213148":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":21,"locations":30,"responsibleParty":87,"collaborators":21,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":21,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":21,"enrollmentInfo":98,"targetDuration":21,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":109,"whyStopped":21,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"BYL719 and paclitaxel","EXPERIMENTAL","All patients enrolled in the study will receive BYL719 once daily plus weekly paclitaxel",[13,14],"Drug: BYL719","Drug: Paclitaxel",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","BYL719","BYL719 will be administered orally once daily on a continuous dosing schedule and dosed on a flat-fixed dose and not adjusted by body weight or body surface area, starting on Day 2 in the dose escalation part and Day 1 in the dose expansion part. In the dose escalation part, the BYL719 starting dose will be 300mg, with anticipated dose escalation to 350mg. In the dose expansion part, BYL719 will be administered at the recommended dose determined in the dose escalation part.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Paclitaxel","Paclitaxel will be administered once weekly at a dose of 80 mg\u002Fm2 i.v. (days 1, 8, 15 and 22) in a 28 day cycle in both dose escalation and expansion.",[9],[27],{"name":28,"affiliation":28,"role":29},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[31,44,54,65,76],{"facility":32,"status":21,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":21},"Highlands Oncology Group","Fayetteville","Arkansas","72703","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-94.15743,36.06258,{"lat":42,"lon":41},{"facility":45,"status":21,"city":46,"state":47,"zip":48,"country":36,"countryCode":37,"cosmosGeoPoint":49,"geoPoint":53,"contacts":21},"Horizon Oncology Center BioAdvance","Lafayette","Indiana","47905",{"type":39,"coordinates":50},[51,52],-86.87529,40.4167,{"lat":52,"lon":51},{"facility":55,"status":21,"city":56,"state":21,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":64,"contacts":21},"Novartis Investigative Site","Toulouse","31059","France","FR",{"type":39,"coordinates":61},[62,63],1.44367,43.60426,{"lat":63,"lon":62},{"facility":55,"status":21,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":75,"contacts":21},"Milan","MI","20141","Italy","IT",{"type":39,"coordinates":72},[73,74],12.59836,42.78235,{"lat":74,"lon":73},{"facility":55,"status":21,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":86,"contacts":21},"Barcelona","Catalonia","08035","Spain","ES",{"type":39,"coordinates":83},[84,85],2.15899,41.38879,{"lat":85,"lon":84},{"type":88,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100213148","phase-1-a-study-to-evaluate-the-potential-benefit-of-the-addition-of-byl719-to-paclitaxel-in-the-treatment-of-breast-cancer-and-head-and-neck-cancer-100213148",false,"NCT02051751","A Study to Evaluate the Potential Benefit of the Addition of BYL719 to Paclitaxel in the Treatment of Breast Cancer and Head-and-neck Cancer","A Phase Ib Open Label Dose Finding Study of BYL719 in Combination With Paclitaxel in Advanced Solid Tumors Followed by Two Expansion Phases in Locally Advanced\u002FMetastatic Chemotherapy Naive HER2 Negative Breast Cancer Patients (HER2- mBC) and in Recurrent and Metastatic Head-and-neck Squamous Cell Carcinoma Patients (HNSCC) Pre-treated With Platinum Based Therapy","Inclusion criteria For entire trial:\n\n1. \\- Adult \\> or = 18 years old\n2. \\- has signed the Informed Consent Form (ICF)\n3. \\- has at least one measurable or non-measurable disease as per RECIST 1.1\n4. \\- has tumor tissue available for the analysis as described in the protocol\n5. \\- has adequate bone marrow and organ function as defined in the protocol\n6. \\- is able to swallow and retain oral medication for the dose escalation part, ALL above PLUS\n7. \\- has a histologically-confirmed, advanced unresectable solid tumors who have progressed on standard therapy (or not been able to tolerate) within three months before screening\u002Fbaseline visit or for whom no standard anticancer therapy exists.\n8. \\- has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2 For dose expansion part, patient has ALL of above first six criteria PLUS either: 9- has a histologically\u002Fcytologically-confirmed HNSCC as detailed in the protocol and an ECOG performance status ≤ 1 or:\n\n   * Patient is a Female with a histologically and\u002For cytologically confirmed diagnosis of breast cancer as detailed in the protocol and an ECOG performance status ≤ 1\n\nCommon exclusion criteria to Dose escalation and Dose expansion parts:\n\n1. \\- has received previous treatment with a PI3K or AKT inhibitor as described in the protocol\n2. \\- has a known hypersensitivity to paclitaxel or other products containing Cremophor\n3. \\- has a contraindication to use the standard pre-treatment for paclitaxel\n4. \\- has a primary central nervous system (CNS) tumor or CNS tumor involvement as detailed in the protocol\n5. \\- has not recovered to grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy\n6. \\- has received radiotherapy \\> or = 4 weeks prior to starting study drugs, with exception of palliative radiotherapy, who has not recovered from side effects of such therapy to baseline or Grade ≤ 1 and\u002For from whom ≥ 30% of the bone marrow was irradiated\n7. \\- has peripheral sensory neuropathy with functional impairment (CTC grade 2 neuropathy or higher)\n8. \\- has undergone major surgery ≤ 4 weeks prior to starting study treatment or who has not recovered from side effects of such procedure\n9. \\- has a clinically significant cardiac disease or impaired cardiac function as detailed in the protocol\n10. \\- is currently receiving medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes (TdP) and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug treatment\n11. \\- has diabetes mellitus requiring insulin treatment and\u002For with clinical signs\n12. \\- has impaired gastrointestinal (GI) function or GI disease as described in the protocol\n13. \\- has a known positive serology for human immunodeficiency virus (HIV), active Hepatitis B, and\u002For active Hepatitis C infection\n14. \\- has any other condition that would, in the Investigator's judgment, preclude patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures\n15. \\- is currently receiving treatment with drugs known to be moderate or strong inhibitors or inducers of isoenzymes CYP3A or CYP2C8 as detailed in the protocol\n16. \\- is currently receiving treatment with agents that are metabolized solely by CYP3A and\u002For have a narrow therapeutic window\n17. \\- has a history of another malignancy within 2 years prior to starting study treatment, except cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervix\n18. \\- Patient has a history of non-compliance to medical regimen or inability to grant consent\n19. \\- Pregnant or nursing (lactating) women\n20. \\- does not apply highly effective contraception during the study and through the duration as defined in the protocol\n\nFor the HNSCC patient's cohort additional exclusion criteria are:\n\n21- Treatment with more than one prior chemotherapy for recurrent\u002Fmetastatic disease as detailed in the protocol 22- Prior taxane treatment for metastatic disease additional exclusion criteria for breast cancer patients' cohort:\n\n\\- has received any prior cytotoxic therapy for the inoperable locally advanced (recurrent or progressive) or metastatic disease, or who had a progression\u002Frecurrent disease within 6 months after completion of an adjuvant\u002Fneoadjuvant therapy as described in the protocol\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply","ALL","18 Years",{"count":99,"type":100},19,"ACTUAL","INTERVENTIONAL",[103],"PHASE1","Dose escalation part:to determine the highest dose of BYL719 administered on a daily basis when given in combination with weekly paclitaxel Dose escalation part: to confirm the safety and tolerability of the BYL719 and paclitaxel combination",[106],"Neoplasms, Breast Neoplasms, Head and Neck Neoplasms",[108],"Solid tumors, Head and neck non squamous cell carcinoma, breast cancer, PI3K inhibitor, BYL719, paclitaxel","COMPLETED","2020-12-04",{"date":112,"type":100},"2020-12-08",{"date":114,"type":100},"2014-03-05",{"date":116,"type":100},"2016-08-19",{"name":28,"class":6},5]