MTD Study PXD-101 in Combination With Paclitaxel + Carboplatin in Chemotherapy-Naive Patients With Stage IV NSCLC

Inclusion Criteria:

A histologically or cytologically confirmed diagnosis of Stage IV (M1a or M1b) NSCLC. Patients with mixed non-small cell histologies are eligible
No prior chemotherapy for the treatment of advanced NSCLC
Prior adjuvant therapy for early stage lung cancer is allowed if completed ≥ 12 months prior to enrollment
Age >= 18 years
Adequate organ function
Any treatment with investigational agent must have completed ≥ 4 weeks prior to enrollment
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Negative pregnancy test for women of childbearing potential.

Patients with brain metastases allowed if:

Directed local therapy was completed 2 weeks prior to enrollment;
There is no evidence of disease progression and;
Steroids are not required

Exclusion Criteria:

Patients with mixed tumors of small cell features
Known infection with HIV, hepatitis B or hepatitis C
Baseline prolongation of QT/QTcF interval or required concomitant medication that may cause Torsade de Pointes
Preexisting ≥Grade 2 neuropathy
Valproic acid treatment within 2 weeks of study enrollment
Systemic steroids, for any indication, stabilized at >10 mg/day prednisone
Known allergy or hypersensitivity to any component of belinostat, paclitaxel or carboplatin
Co-existing active infection or any other uncontrolled medical condition likely to interfere with trial procedures
Active concurrent malignancy (except basal cell carcinoma or cervical intraepithelial neoplasia, other potentially cured malignancy that has been in remission for five years or prior adjuvant therapy for early stage lung cancer that is completed ≥ 12 months ago)
Pregnant or breast-feeding women