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• W2306053308 abstract "// Hatem H. Soliman 1 , Susan E. Minton 1 , Hyo Sook Han 1 , Roohi Ismail-Khan 1 , Anthony Neuger 1 , Fatema Khambati 1 , David Noyes 1 , Richard Lush 1 , Alberto A. Chiappori 1 , John D. Roberts 2 , Charles Link 3 , Nicholas N. Vahanian 3 , Mario Mautino 3 , Howard Streicher 4 , Daniel M. Sullivan 1 and Scott J. Antonia 1 1 H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA 2 Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia, USA 3 NewLink Genetics Inc., Ames, Iowa, USA 4 Cancer Therapeutics Evaluation Program, National Cancer Institute, Bethesda, Maryland, USA Correspondence to: Hatem H. Soliman, email: // Keywords : indoleamine 2,3 dioxygenase, 1-methyl-D-tryptophan, indoximod, immunomodulator Received : February 11, 2016 Accepted : March 10, 2016 Published : March 20, 2016 Abstract Purpose: Indoximod is an oral inhibitor of the indoleamine 2,3-dioxygenase pathway, which causes tumor-mediated immunosuppression. Primary endpoints were maximum tolerated dose (MTD) and toxicity for indoximod in patients with advanced solid tumors. Secondary endpoints included response rates, pharmacokinetics, and immune correlates. Experimental Design: Our 3+3 phase I trial comprised 10 dose levels (200, 300, 400, 600, and 800 mg once/day; 600, 800, 1200, 1600, and 2000 mg twice/day). Inclusion criteria were measurable metastatic solid malignancy, age ≥18 years, and adequate organ/marrow function. Exclusion criteria were chemotherapy ≤ 3 weeks prior, untreated brain metastases, autoimmune disease, or malabsorption. Results: In 48 patients, MTD was not reached at 2000 mg twice/day. At 200 mg once/day, 3 patients previously treated with checkpoint inhibitors developed hypophysitis. Five patients showed stable disease >6 months. Indoximod plasma AUC and Cmax plateaued above 1200mg. Cmax (~12 μM at 2000 mg twice/day) occurred at 2.9 hours, and half-life was 10.5 hours. C reactive protein (CRP) levels increased across multiple dose levels. Conclusions: Indoximod was safe at doses up to 2000 mg orally twice/day. Best response was stable disease >6 months in 5 patients. Induction of hypophysitis, increased tumor antigen autoantibodies and CRP levels were observed." @default.
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• W2306053308 date "2016-03-20" @default.
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• W2306053308 title "A phase I study of indoximod in patients with advanced malignancies" @default.
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• W2306053308 doi "https://doi.org/10.18632/oncotarget.8216" @default.
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