Clinical Trial Review

February 2016 | Volume 15 | Issue 2 | Features | 253 | Copyright © February 2016


screened positive for NAFLD will be further evaluated for ruling out the other etiologies of fatty liver such as alcohol abuse and hepatitis.
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Icotinib Hydrochloride Cream in Healthy Adults and Psoriasis Patients

This is a phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of icotinib hydrochloride cream in healthy adults and patients with mild to moderate psoriasis.
Icotinib hydrochloride is a small-molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, which has been approved for the treatment of advanced non-small-cell lung cancer (NSCLC) in China in its oral form. As EGFR is implicated in the pathogenesis of psoriasis, icotinib hydrochloride is being developed as a cream for the treatment of mild-to-moderate psoriasis.
This is a single-center, randomized, double-blind, placebo-controlled study of icotinib hydrochloride cream by topical administration. The study is designed in 2 parts: in healthy subjects (phase 1) followed by patients with mild to moderate psoriasis (phase 2). One percent and 2% icotinib hydrochloride cream will be initially applied to healthy subjects. Once the study in healthy adults shows favorable safety and tolerability, a study in patients with mild-to-moderate psoriasis will follow. Approximately 28 subjects will be enrolled, including 12 healthy subjects (phase 1) and 16 patients with psoriasis (phase 2).
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Neoadjuvant and Adjuvant Checkpoint Blockade in Patients With Clinical Stage III or Oligometastatic Stage IV Melanoma

The goal of this clinical research study is to learn if giving nivolumab alone or in combination with ipilimumab before and after surgery can help to control metastatic melanoma. The safety of these drugs will also be studied.
Patients must have histologically or cytologically confirmed stage 3 B/C or stage 4 oligometastatic melanoma. Oligometastatic melanoma is defined as 3 or fewer areas of resectable disease, excluding central nervous system and bone involvement. Patients with cutaneous, mucosal, acral, ocular, or unknown primary melanomas are eligible for enrollment. For patients with stage 4 disease with distant lymph nodes, a maximum of 3 separate lymph node sites fit the definition of oligometastatic disease. Resectable tumors are defined as having no significant vascular, neural, or bony involvement. Only cases where a complete surgical resection with tumor-free margins can safely be achieved are defined as resectable.
Eligible patients will be randomly assigned to 1 of 2 study groups. Group A will receive nivolumab by vein every 2 weeks for a total of 4 doses, and then have surgery. After that, they will receive nivolumab for an additional 6 months. Group B will receive nivolumab and ipilimumab by vein every 3 weeks for 3 doses, and then have surgery. After that, they will receive nivolumab alone for 6 months.
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