BACKGROUND: Plinabulin ( @entity69933 ) is a vascular disrupting agent (VDA) that @entity5 vascular endothelial cell architecture resulting in selective collapse of @entity5 vasculature producing anti- @entity5 activity alone or in combination with cytotoxic agents. The objective of this study was to assess the recommended Phase 2 dose (RP2D) of plinabulin combined with @entity1205 . @entity1 AND METHODS: @entity1 received 75 mg/m(2) @entity1205 on day 1 and plinabulin on days 1 and 8 intravenously in 21 day cycles. Plinabulin was escalated from the biologically effective dose (BED) of 13.5 mg/m(2) to the standard single agent dose of 30 mg/m(2) using a "3+3" design. RESULTS: Thirteen @entity1 were enrolled. Adverse events were consistent with those of both agents alone. Fatigue, @entity158 , @entity390 , @entity294 and @entity391 were the most common events. One dose limiting @entity137 of @entity390 , @entity391 , @entity2700 and @entity1398 occurred. The RP2D was 30 mg/m(2) of plinabulin with 75 mg/m(2) @entity1205 . Pharmacokinetics did not indicate drug-drug interactions. Of the 8 @entity1 with NSCLC evaluable for response, 2 achieved a partial response and 4 demonstrated lesser decreases in @entity5 measurements. CONCLUSIONS: The combination of full doses of plinabulin and @entity1205 is tolerable. With encouraging antitumor activity, this supported further development of this combination.

Phase 1 study of the novel vascular disrupting agent plinabulin ( XXXX ) and @entity1205 .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'PATIENTS'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity390 :: ('MESH:D009325', 'Disease') :: ['nausea'] @entity2700 :: ('MESH:D003681', 'Disease') :: ['dehydration'] @entity5 :: ('MESH:D009369', 'Disease') :: ['destabilizes tumor', 'tumor', 'established tumor'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhea'] @entity391 :: ('MESH:D014839', 'Disease') :: ['vomiting'] @entity1205 :: ('MESH:C067311', 'Chemical') :: ['docetaxel'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity158 :: ('MESH:D010146', 'Disease') :: ['pain'] @entity69933 :: ('MESH:C514351', 'Chemical') :: ['NPI-2358']
@entity69933 :: (MESH:C514351,Chemical) :: ['NPI-2358']
