Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult patients with metastatic or locally advanced solid tumors, for whom weekly paclitaxel treatment is indicated (BEZ235-paclitaxel /BKM120-paclitaxel treatment)
HER2+ metastatic or locally advanced breast cancer patients eligible for weekly paclitaxel and trastuzumab (BEZ235-paclitaxel-trastuzumab /BKM120-paclitaxel-trastuzumab treatment)
Adult patients (≥ 18 years) (males, females)
World Health Organization (WHO) performance status ≤ 2
Adequate bone marrow function:
Adequate hepatic and renal function:
You may not be if
Patients with primary central nervous system (CNS) tumor or CNS tumor involvement. 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
Patients who have received prior systemic anticancer therapy within the following time frames
Cyclical chemotherapy: ≤ 3 weeks before study treatment (6 weeks for patients treated with nitrosoureas)
Biological therapy: ≤ 4 weeks before study treatment, except treatment with trastuzumab (both parts of the trial)
Investigational drug: ≤ 4 weeks before study treatment
Patients who have undergone major surgery ≤ 4 weeks before study treatment
Patients receiving chronic treatment with corticosteroids or other immunosuppressive agents
Patients with uncontrolled, unmanageable, treatment-refractory diabetes mellitus
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
