Study of Safety and Efficacy of Alpelisib With Everolimus or Alpelisib With Everolimus and Exemestane in Advanced Breast Cancer Patients, Renal Cell Cancer and Pancreatic Tumors
Completed · Phase 1
Conditions studied: Neoplasms, Breast Neoplasms, Kidney Neoplasms, Pancreatic Neuroendocine Neoplasms (pNETs)
In brief
Dose escalation part: to determine the highest dose of alpelisib administered on a daily basis when given in combination with daily everolimus or in combination with daily everolimus and exemestane. Dose expansion part: To describe safety and tolerability of the alpelisib and everolimus or alpelisib, everolimus and exemestane combinations.
Key facts
- Study ID
- NCT02077933
- Run by
- Novartis Pharmaceuticals
- People needed
- 79
- Starts
- 2014-05-14
- Expected to finish
- 2019-04-12
- Last updated by the study team
- 2020-12-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Patient has received previous treatment with a PI3K and/or AKT and/or mTOR inhibitor (mTOR inhibitor is allowed in expansion cohorts where patients should have areceived a prior mTOR inhibitor)
- Known intolerance or hypersensitivity to Everolimus or other rapamycin analogs
- Patient with primary central nervous system (CNS) tumor or CNS tumor involvement as detailed in the protocol
- Patient with diabetes mellitus, or documented steroid-induced diabetes mellitus
- Patient has a history of another malignancy within 2 years prior to starting study treatment as described in the protocol
- Patient who has not recovered to grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy as detailed in the protocol
- Patient who has had systemic therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to starting study treatment
- Patient who has received radiotherapy ≤ 4 weeks prior to starting study drugs, with exception of palliative radiotherapy (≤ 2 weeks prior to starting study drugs), who has not recovered from side effects of such therapy to baseline or Grade ≤ 1 and/or from whom ≥ 30% of the bone marrow was irradiated
- Patient who has undergone major surgery ≤ 4 weeks prior to starting study treatment or who has not recovered from side effects of such procedure
- Patient has a clinically significant cardiac disease or impaired cardiac function or any severe and/or uncontrolled medical conditions as detailed in the protocol
- Patient who 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
- Patient who has participated in a prior investigational study within 30 days prior to enrollment as described in the protocol
- Patient who is currently receiving treatment with drugs known to be moderate or strong inhibitors or inducers of isoenzymes CYP34A or CYP2C8 as described in the protocol. Switching to a different medication prior to start of treatment is allowed
- Patient with impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral alpelisib, everolimus, exemestane
- Patient with known positive serology for human immunodeficiency virus
- Patients who have received live attenuated vaccines within 1 week of start of study drug and during the study as specified in the protocol.
- Pregnant or nursing (lactating) woman as detailed in the protocol.
- Patient who does not apply highly effective contraception during the study and through the duration as defined in the protocol
- Patients in the mTOR inhibitor-pretreated cohorts: all of above first 19 criteria plus have discontinued prior mTOR inhibitor therapy due to non-tolerable toxicity
Where it is running
- Highlands Oncology Group — Fayetteville, Arkansas, United States
- Memorial Sloan Kettering Cancer Center SC - BYL719Z2102 — New York, New York, United States
- Novartis Investigative Site — Bordeaux, France
- Novartis Investigative Site — Bordeaux, France
- Novartis Investigative Site — Paris, France
- Novartis Investigative Site — Villejuif, France
- Novartis Investigative Site — Berlin, Germany
- Novartis Investigative Site — Essen, Germany
- Novartis Investigative Site — Essen, Germany
- Novartis Investigative Site — Hanover, Germany
- Novartis Investigative Site — Hong Kong, Hong Kong
- Novartis Investigative Site — Budapest, Hungary
- Novartis Investigative Site — Ancona, AN, Italy
- Novartis Investigative Site — Milan, MI, Italy
- Novartis Investigative Site — Modena, MO, Italy
- Novartis Investigative Site — Verona, VR, Italy
- Novartis Investigative Site — Amsterdam, Netherlands
- Novartis Investigative Site — Utrecht, Netherlands
- Novartis Investigative Site — Barcelona, Catalonia, Spain
- Novartis Investigative Site — Madrid, Spain
- Novartis Investigative Site — Madrid, Spain
- Novartis Investigative Site — Manchester, United Kingdom
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.