scholarly journals Phase I study of nintedanib in Japanese patients with advanced hepatocellular carcinoma and liver impairment

2016 ◽  
Vol 107 (12) ◽  
pp. 1791-1799 ◽  
Author(s):  
Takuji Okusaka ◽  
Taiga Otsuka ◽  
Hideki Ueno ◽  
Shuichi Mitsunaga ◽  
Rie Sugimoto ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Phase I ◽  
Phase I Study ◽  
Japanese Patients ◽  
Advanced Hepatocellular Carcinoma ◽  
Liver Impairment

scholarly journals Phase I study of tivantinib in Japanese patients with advanced hepatocellular carcinoma: Distinctive pharmacokinetic profiles from other solid tumors

2015 ◽  
Vol 106 (5) ◽  
pp. 611-617 ◽  
Author(s):  
Takuji Okusaka ◽  
Takeshi Aramaki ◽  
Yoshitaka Inaba ◽  
Shinichiro Nakamura ◽  
Manabu Morimoto ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Phase I ◽  
Solid Tumors ◽  
Phase I Study ◽  
Japanese Patients ◽  
Advanced Hepatocellular Carcinoma ◽  
Pharmacokinetic Profiles

scholarly journals Phase I study of TAC-101, an oral synthetic retinoid, in Japanese patients with advanced hepatocellular carcinoma

2012 ◽  
Vol 103 (8) ◽  
pp. 1524-1530 ◽  
Author(s):  
Takuji Okusaka ◽  
Hideki Ueno ◽  
Masafumi Ikeda ◽  
Yoriko Takezako ◽  
Chigusa Morizane
Keyword(s):  
Hepatocellular Carcinoma ◽  
Phase I ◽  
Phase I Study ◽  
Japanese Patients ◽  
Advanced Hepatocellular Carcinoma ◽  
Synthetic Retinoid

scholarly journals Phase I study of sorafenib in Japanese patients with hepatocellular carcinoma

2007 ◽  
Vol 0 (0) ◽  
pp. 071113200242005-??? ◽  
Author(s):  
Junji Furuse ◽  
Hiroshi Ishii ◽  
Kohei Nakachi ◽  
Eiichiro Suzuki ◽  
Satoshi Shimizu ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Phase I ◽  
Phase I Study ◽  
Japanese Patients

A phase I study of pazopanib in patients with advanced hepatocellular carcinoma

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 3561-3561
Author(s):  
C. C. Yau ◽  
P. J. Chen ◽  
C. M. Curtis ◽  
P. S. Murphy ◽  
A. B. Suttle ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Phase I ◽  
Phase I Study ◽  
Angiogenesis Inhibitor ◽  
Maximum Tolerated Dose ◽  
Maximum Plasma ◽  
Advanced Hepatocellular Carcinoma ◽  
Eligibility Criteria ◽  
Dce Mri ◽  
Tumor Permeability

3561 Background: Patients (pts) with advanced hepatocellular carcinoma (HCC) have a poor prognosis. HCC is a highly vascular tumor with increased levels of angiogenic factors including VEGF and VEGFR. Pazopanib (GW786034) is an oral angiogenesis inhibitor targeting VEGFR, PDGFR, and c-Kit. A Phase I study was conducted to determine the maximum tolerated dose (MTD), safety, pharmacokinetics, pharmacodynamics and efficacy of pazopanib in patients with locally unresectable and/or advanced HCC. Methods: Eligibility criteria included unresectable and/or metastatic HCC with at least 1 target lesion, recovery from prior systemic regimens, ECOG PS 0 or 1, Child-Pugh A, and adequate organ function. Doses of pazopanib were escalated from 200 mg once daily (QD) to 800 mg QD in a 3 + 3 design. DCE- MRI was performed to assess changes in tumor permeability. Results: 27 Asian pts have been enrolled at QD doses of 200 (4 pts), 400 (10), 600 (8), 800 (5): median (range) age = 61 (38–76); M/F = 85%/15%; ECOG 0/1 = 59%/41%; 81% with metastatic disease; 67% with Stage IV; 22% with prior systemic therapy, 26% with prior TACE. Most common AEs were: diarrhea (59%; 4% Gr 3); hypertension (44%; 26% Gr 3), cough (19%); fatigue (19%; 4% Gr 3); and hair depigmentation (15%). Hepatobiliary lab abnormalities were: AST elevation (63%; 15% Gr 3), hyperbilirubinemia (63%; 4% Gr 3), ALT elevation (41%; 7% Gr 3), and Alk phos (37%; 4% Gr 3). DLTs were Gr 3 malaise (1 pt) and Gr 3 AST/ALT elevation (1 pt) at 800 mg. MTD was determined to be 600 mg QD. Median (range) days on study was 85 (4–663) overall; 106 days (4–274) at the MTD. Best response was PR in 2 pts (7%; 1 at 800mg, 1 at 600 mg) and SD > 4 mos in 11 pts (41%). Median TTP at the MTD was 137.5 days (4–280 days). Median % change in tumor permeability (Ktrans) following 3 weeks of pazopanib administration at the MTD (5 pts) was 45%. Predose and maximum plasma pazopanib concentrations at 800 mg QD were similar to values observed previously at the same dose. Conclusions: Pazopanib has a manageable safety profile in HCC at the MTD of 600mg QD. Preliminary evidence of antitumor activity was observed. Changes in tumor DCE-MRI parameters were seen following repeated dose pazopanib administration. [Table: see text]

scholarly journals First-in-Man Phase I Study of GC33, a Novel Recombinant Humanized Antibody Against Glypican-3, in Patients with Advanced Hepatocellular Carcinoma

2013 ◽  
Vol 19 (4) ◽  
pp. 920-928 ◽  
Author(s):  
Andrew X. Zhu ◽  
Philip J. Gold ◽  
Anthony B. El-Khoueiry ◽  
Thomas A. Abrams ◽  
Hideo Morikawa ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Phase I ◽  
Phase I Study ◽  
Advanced Hepatocellular Carcinoma ◽  
Humanized Antibody

A phase I study of continuous hepatic arterial infusion of Irinotecan in patients with locally advanced hepatocellular carcinoma

2011 ◽  
Vol 43 (12) ◽  
pp. 1015-1021 ◽  
Author(s):  
Giovanni Brandi ◽  
Guido Biasco ◽  
Maria Grazia Mirarchi ◽  
Rita Golfieri ◽  
Antonello Di Paolo ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Phase I ◽  
Phase I Study ◽  
Locally Advanced ◽  
Hepatic Arterial Infusion ◽  
Advanced Hepatocellular Carcinoma ◽  
Arterial Infusion

scholarly journals A Phase I Study of Combination Therapy with Sorafenib and 5-Fluorouracil in Patients with Advanced Hepatocellular Carcinoma

Drugs in R&D ◽  
2017 ◽  
Vol 17 (3) ◽  
pp. 381-388 ◽  
Author(s):  
Takuya Sho ◽  
Mitsuru Nakanishi ◽  
Kenichi Morikawa ◽  
Masatsugu Ohara ◽  
Naoki Kawagishi ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Combination Therapy ◽  
Phase I ◽  
Phase I Study ◽  
Advanced Hepatocellular Carcinoma

scholarly journals Japanese phase I study of GC 33, a humanized antibody against glypican‐3 for advanced hepatocellular carcinoma

2014 ◽  
Vol 105 (4) ◽  
pp. 455-462 ◽  
Author(s):  
Masafumi Ikeda ◽  
Shinichi Ohkawa ◽  
Takuji Okusaka ◽  
Shuichi Mitsunaga ◽  
Satoshi Kobayashi ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Phase I ◽  
Phase I Study ◽  
Advanced Hepatocellular Carcinoma ◽  
Humanized Antibody

Phase I study of everolimus in combination with sorafenib in patients with advanced hepatocellular carcinoma (HCC).

2011 ◽  
Vol 29 (15_suppl) ◽  
pp. 4074-4074 ◽  
Author(s):  
R. S. Finn ◽  
R. T. P. Poon ◽  
T. Yau ◽  
H. Klumpen ◽  
L. Chen ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Phase I ◽  
Phase I Study ◽  
Advanced Hepatocellular Carcinoma
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