Trial Details
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Purpose
The purpose of this study is to define the maximum tolerated dose (MTD) safety, tolerability and efficacy of belinostat when given with paclitaxel and carboplatin in patients with stage IV NSCLC who have not received prior chemotherapy for advanced NSCLC.
Other clinical endpoints to be evaluated in this study include: progressive free survival (PFS) and objective response rate (ORR) based on RECIST criteria. Safety will be evaluated during the study and for 30 days after the last administration of study drug.
Study Type: Interventional
Study Design: Approximately 35 patients will be enrolled at various sites in this phase I/II, open-label, non-randomized multi-center, dose escalating combination treatments study with MTD expansion component study.
Primary Outcome Measures: Maximum Tolerated Dose (MTD)
Secondary Outcome Measures:
- Safety and Tolerability
- Progression-Free Survival (PFS)
- Objective Response Rate (ORR)
Intervention Details: Patients will be treated with 1000 mg/mē belinostat administered as a 30-minute infusion given daily for 5 days every 3 weeks plus paclitaxel 200 mg/m² and carboplatin AUC 6 given on day 3 only, every 3 week cycle until there is disease progression or intolerable toxicities or for a maximum of 6 total cycles.
Criteria
Inclusion criteria:
- A hisotologically or cytologically confirmed diagnosis of Stage IV (M1a or M1b) NSCLC. Patients with mixed non-small cell histologies are eligible
- Patients must not have received any prior chemotherapy for the treatment of advanced NSCLC
- Age >= 18 years.
- Adequate organ function
- 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 within ≥2 weeks prior to enrollment;
- There is no evidence of disease progression and;
- Steroids are not required
- Patients with mixed tumors of small cell features
- Known infection with HIV, hepatitis B or hepatitis C
- Baseline prolongation of QT/QTcF interval
- Preexisting ≥ Grade 2 neuropathy
- 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 or other potentially cured malignancy that has been in remission for five years)
- Pregnant or breast-feeding women
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Additional Resources
http://www.clinicaltrials.gov/
