An open-label phase I/II study of tamibarotene in patients with advanced hepatocellular carcinoma View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2014-01

AUTHORS

Fumihiko Kanai, Shuntaro Obi, Shigetoshi Fujiyama, Shuichiro Shiina, Hideyuki Tamai, Hitoshi Mochizuki, Yukihiro Koike, Jun Imamura, Takayoshi Yamaguchi, Isamu Saida, Osamu Yokosuka, Masao Omata

ABSTRACT

AIM: Tamibarotene is a synthetic retinoid expected to inhibit tumor-cell proliferation and to induce apoptosis by selective interaction with retinoic acid receptor α/β. We conducted an open-label phase I/II study to determine the maximum tolerated dose (MTD) and recommended dose (RD), and to evaluate the pharmacokinetics, efficacy, and safety profiles for advanced hepatocellular carcinoma (HCC). METHODS: Patients with histologically confirmed, measurable, unresectable HCC of Child-Pugh classification A or B and with no effective systemic or local therapies were eligible. In phase I, patients were assigned based on the 3 + 3 dose escalation criteria to receive tamibarotene at 8, 12, and 16 mg/day. The RD determined in phase I was employed for phase II. The planned sample size in phase II was 25, including the RD-treated patients in phase I. RESULTS: Thirty-six patients were enrolled. No patients experienced dose-limiting toxicity (DLT) at 8 mg/day. However, two out of six patients experienced the DLTs at 12 mg/day: one experienced thrombosis in a limb vein and pulmonary artery, and the other experienced an increase of γ-GTP. The MTD and RD were determined as 12 and 8 mg/day, respectively. In phase II, one patient achieved partial response, and seven achieved stable disease. The disease control rate was 32 % (95 % CI: 15.0-53.5). The following drug-related serious adverse events were reported: thrombosis in a limb vein, pulmonary artery, and portal vein; interstitial lung disease; and vomiting. CONCLUSIONS: Tamibarotene demonstrated the inhibition of tumor cell growth in advanced HCC with acceptable tolerance. More... »

PAGES

94-103

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s12072-013-9459-7

DOI

http://dx.doi.org/10.1007/s12072-013-9459-7

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1045113608

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/26202410


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    "description": "AIM: Tamibarotene is a synthetic retinoid expected to inhibit tumor-cell proliferation and to induce apoptosis by selective interaction with retinoic acid receptor \u03b1/\u03b2. We conducted an open-label phase I/II study to determine the maximum tolerated dose (MTD) and recommended dose (RD), and to evaluate the pharmacokinetics, efficacy, and safety profiles for advanced hepatocellular carcinoma (HCC).\nMETHODS: Patients with histologically confirmed, measurable, unresectable HCC of Child-Pugh classification A or B and with no effective systemic or local therapies were eligible. In phase I, patients were assigned based on the 3\u00a0+\u00a03 dose escalation criteria to receive tamibarotene at 8, 12, and 16\u00a0mg/day. The RD determined in phase I was employed for phase II. The planned sample size in phase II was 25, including the RD-treated patients in phase I.\nRESULTS: Thirty-six patients were enrolled. No patients experienced dose-limiting toxicity (DLT) at 8\u00a0mg/day. However, two out of six patients experienced the DLTs at 12\u00a0mg/day: one experienced thrombosis in a limb vein and pulmonary artery, and the other experienced an increase of \u03b3-GTP. The MTD and RD were determined as 12 and 8\u00a0mg/day, respectively. In phase II, one patient achieved partial response, and seven achieved stable disease. The disease control rate was 32\u00a0% (95\u00a0% CI: 15.0-53.5). The following drug-related serious adverse events were reported: thrombosis in a limb vein, pulmonary artery, and portal vein; interstitial lung disease; and vomiting.\nCONCLUSIONS: Tamibarotene demonstrated the inhibition of tumor cell growth in advanced HCC with acceptable tolerance.", 
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Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/pub.10.1007/s12072-013-9459-7'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1007/s12072-013-9459-7'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1007/s12072-013-9459-7'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1007/s12072-013-9459-7'


 

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