Study of the Combination of BKM120 and Cisplatin or Carboplatin in Patients With Advanced Solid Tumors

Inclusion criteria:

• Patient has provided a signed Informed Consent Form (ICF) obtained prior to any screening procedure;
• Patient is ≥ 18 years at the day of consenting to the study
• Patient has an ECOG performance status ≤ 1
• Pathologically confirmed recurrent or metastatic advanced solid tumor, for which treatment with a platinum agent is indicated
• Life expectancy ≥ 6 months
• Patient has adequate bone marrow and organ function
• Patient must be able to swallow and retain oral medication
• Patient may have received more than 1 prior cytotoxic chemotherapy regimens for recurrent or metastatic disease
• Negative serum pregnancy test within 48 hours before starting study treatment in women with childbearing potential
• Patients may receive concurrent radiation therapy to painful bone metastases or areas of impending bone fracture
• Patients must be disease-free of other prior invasive cancers for > 5 year
• Patients must complete all screening assessments as outlined in the protocol

Exclusion Criteria:

• Patient has received previous treatment with PI3K and/or mTOR inhibitors
• Patient has received chemotherapy or targeted anticancer therapy ≤ 4 weeks prior to starting study drug or has not recovered from side effects of such therapy
• Patient has symptomatic CNS metastases (Patients with controlled and asymptomatic CNS metastases may participate in this trial)
• Patient has any of the below mood disorders as judged by the Investigator or a Psychiatrist, or meets the cut-off score of ≥ 10 in the PHQ-9 or a cut-off of ≥ 15 in the GAD-7 mood scale, respectively, or selects a positive response of '1, 2, or 3' to question number 9 regarding potential for suicidal thoughts ideation in the PHQ-9 (independent of the total score of the PHQ-9)
• Patient is concurrently using other approved or investigational antineoplastic agent
• Patient has received wide field radiotherapy ≤ 4 weeks prior to starting study drug
• Patient has had major surgery within 2 weeks days prior to starting study drug;
• Patients with diabetes mellitus or steroid-induced diabetes mellitus or known intolerance to glucides or fasting glucose > 120 mg/dL or HbA1c > 8 %

• Patient has important cardiac disease

  • LVEF < 50%; NYHA Class III or IV
  • QTc > 480 msec; Congenital long QT syndrome
  • Clinically significant resting bradycardia
  • Complete left bundle branch block; Right bundle branch block + left anterior hemiblock
• Patient has impairment of GI function or GI disease
• Patient receiving chronic treatment with steroids or another immunosuppressive agent.
• Patient has other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate his/her participation in the clinical study (e.g.,chronic pancreatitis, active or chronic liver disease, renal disease etc.)
• Patient has diarrhea ≥ 2 CTCAE grade 2
• Preexisting peripheral neuropathy > grade 1
• Patient has been treated with any hematopoietic colony-stimulating growth factors ≤ 2 weeks prior to starting study drug
• Prior hypersensitivity reaction to carboplatin or cisplatin
• Patient is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or patient has a history of non-compliance to medical regimen
• Patient is currently being treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug.
• Patient has a known history of HIV (infection; 21. Patient is a pregnant or nursing (lactating) woman
• Patient is a man or woman of childbearing potential unwilling to use a double barrier method for birth control throughout the trial