Study of Cisplatin and Pemetrexed in Combination With Panobinostat in Solid Tumors

Exclusion Criteria

• •Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer.
• •Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first panobinostat treatment.
• •Patients who have received chemotherapy, any investigational drug or undergone major surgery \< 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
• •Impaired cardiac function
• •Other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol
• •Concomitant use of drugs which are generally recognized to have a risk of causing torsades de pointes where such treatment cannot be discontinued or switched to a different medication prior to starting study drug
• •Patients with unresolved diarrhea ≥ CTCAE grade 2
• •Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral panobinostat. Inability to swallow panobinostat capsules whole.
• •Concomitant use of any anti-cancer therapy or radiation therapy
• •Uncontrolled or symptomatic brain metastases.
• •Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not willing to use a double barrier method of contraception during the study and 3 months after the end of treatment. One of these methods of contraception must be a barrier method. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months).
• •Male patients whose sexual partners are WOCBP not using a double method of contraception during the study and 3 months after the end of treatment.
• •Known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required
• •Any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent