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
Inclusion Criteria:
- 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:
Exclusion Criteria:
- 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
Other protocol-defined inclusion/exclusion criteria may apply