Literature DB >> 21484248

A phase I study of oral panobinostat (LBH589) in Japanese patients with advanced solid tumors.

Akira Fukutomi1, Kiyohiko Hatake, Kaoru Matsui, Sakura Sakajiri, Tomonori Hirashima, Hiromi Tanii, Ken Kobayashi, Nobuyuki Yamamoto.   

Abstract

OBJECTIVE: The objective was to determine the maximum tolerated dose and the dose-limiting toxicity of panobinostat (LBH589) when administered as a single agent to adult patients with advanced solid tumors or cutaneous T-cell lymphoma whose disease had progressed despite standard therapy or for whom no standard therapy existed.
METHODS: Panobinostat was administered orally once daily on Monday, Wednesday, and Friday of each week. A total of 13 patients were treated with one of three initial doses: 10 mg (n = 3), 15 mg (n = 4), or 20 mg (n = 6).
RESULTS: No dose-limiting toxicity was observed in 12 evaluable patients. The most frequently reported adverse events, regardless of whether they were related to the study drug, were diarrhea and nausea in 10 patients (76.9%). Thrombocytopenia was reported in 12 of 13 patients (92.3%). Five of 11 patients (45.4%) had stable disease.
CONCLUSION: Panobinostat administered orally once daily on Monday, Wednesday, and Friday of each week was well tolerated at doses up to 20 mg in Japanese patients. Dose escalation did not proceed after exploration of the 20 mg dose due to emerging global clinical data at that time.

Entities:  

Mesh:

Substances:

Year:  2011        PMID: 21484248     DOI: 10.1007/s10637-011-9666-9

Source DB:  PubMed          Journal:  Invest New Drugs        ISSN: 0167-6997            Impact factor:   3.850


  15 in total

1.  Clinical experience with intravenous and oral formulations of the novel histone deacetylase inhibitor suberoylanilide hydroxamic acid in patients with advanced hematologic malignancies.

Authors:  Owen A O'Connor; Mark L Heaney; Lawrence Schwartz; Stacie Richardson; Robert Willim; Barbara MacGregor-Cortelli; Tracey Curly; Craig Moskowitz; Carol Portlock; Steven Horwitz; Andrew D Zelenetz; Stanley Frankel; Victoria Richon; Paul Marks; William K Kelly
Journal:  J Clin Oncol       Date:  2005-12-05       Impact factor: 44.544

Review 2.  Challenges of evaluating the cardiac effects of anticancer agents.

Authors:  Susan E Bates; Douglas R Rosing; Tito Fojo; Richard L Piekarz
Journal:  Clin Cancer Res       Date:  2006-07-01       Impact factor: 12.531

3.  Mechanisms of HDAC inhibitor-induced thrombocytopenia.

Authors:  Hideaki Matsuoka; Akira Unami; Takao Fujimura; Takahisa Noto; Yoko Takata; Katsuhiko Yoshizawa; Hiroaki Mori; Ichiro Aramori; Seitaro Mutoh
Journal:  Eur J Pharmacol       Date:  2007-06-26       Impact factor: 4.432

Review 4.  Clinical studies of histone deacetylase inhibitors.

Authors:  H Miles Prince; Mark J Bishton; Simon J Harrison
Journal:  Clin Cancer Res       Date:  2009-06-09       Impact factor: 12.531

5.  Bexarotene is effective and safe for treatment of refractory advanced-stage cutaneous T-cell lymphoma: multinational phase II-III trial results.

Authors:  M Duvic; K Hymes; P Heald; D Breneman; A G Martin; P Myskowski; C Crowley; R C Yocum
Journal:  J Clin Oncol       Date:  2001-05-01       Impact factor: 44.544

6.  Histone deacetylase inhibitor panobinostat induces clinical responses with associated alterations in gene expression profiles in cutaneous T-cell lymphoma.

Authors:  Leigh Ellis; Yan Pan; Gordon K Smyth; Daniel J George; Chris McCormack; Roxanne Williams-Truax; Monica Mita; Joachim Beck; Howard Burris; Gail Ryan; Peter Atadja; Dale Butterfoss; Margaret Dugan; Kenneth Culver; Ricky W Johnstone; H Miles Prince
Journal:  Clin Cancer Res       Date:  2008-07-15       Impact factor: 12.531

7.  GATA-factor dependence of the multitype zinc-finger protein FOG-1 for its essential role in megakaryopoiesis.

Authors:  Aaron N Chang; Alan B Cantor; Yuko Fujiwara; Maya B Lodish; Steven Droho; John D Crispino; Stuart H Orkin
Journal:  Proc Natl Acad Sci U S A       Date:  2002-06-20       Impact factor: 11.205

Review 8.  Histone deacetylase inhibitors in cancer therapy.

Authors:  Andrew A Lane; Bruce A Chabner
Journal:  J Clin Oncol       Date:  2009-10-13       Impact factor: 44.544

Review 9.  Development of the pan-DAC inhibitor panobinostat (LBH589): successes and challenges.

Authors:  Peter Atadja
Journal:  Cancer Lett       Date:  2009-04-02       Impact factor: 8.679

10.  Induction of fetal hemoglobin expression by the histone deacetylase inhibitor apicidin.

Authors:  Olaf Witt; Sven Monkemeyer; Gabi Rönndahl; Bernhard Erdlenbruch; Dirk Reinhardt; Katrin Kanbach; Arnulf Pekrun
Journal:  Blood       Date:  2002-10-17       Impact factor: 22.113

View more
  22 in total

Review 1.  Panobinostat: first global approval.

Authors:  Karly P Garnock-Jones
Journal:  Drugs       Date:  2015-04       Impact factor: 9.546

Review 2.  Clinical Pharmacokinetics and Pharmacodynamics of Panobinostat.

Authors:  Mathilde Van Veggel; Elsbeth Westerman; Paul Hamberg
Journal:  Clin Pharmacokinet       Date:  2018-01       Impact factor: 6.447

3.  Phase I study of bevacizumab, everolimus, and panobinostat (LBH-589) in advanced solid tumors.

Authors:  John H Strickler; Alexander N Starodub; Jingquan Jia; Kellen L Meadows; Andrew B Nixon; Andrew Dellinger; Michael A Morse; Hope E Uronis; P Kelly Marcom; S Yousuf Zafar; Sherri T Haley; Herbert I Hurwitz
Journal:  Cancer Chemother Pharmacol       Date:  2012-06-29       Impact factor: 3.333

4.  Celastrol increases glucocerebrosidase activity in Gaucher disease by modulating molecular chaperones.

Authors:  Chunzhang Yang; Cody L Swallows; Chao Zhang; Jie Lu; Hongbin Xiao; Roscoe O Brady; Zhengping Zhuang
Journal:  Proc Natl Acad Sci U S A       Date:  2013-12-18       Impact factor: 11.205

5.  Phase I dose-escalating study of panobinostat (LBH589) administered intravenously to Japanese patients with advanced solid tumors.

Authors:  Sachi Morita; Satoshi Oizumi; Hironobu Minami; Koichi Kitagawa; Yoshito Komatsu; Yutaka Fujiwara; Megumi Inada; Satoshi Yuki; Naomi Kiyota; Ayako Mitsuma; Masataka Sawaki; Hiromi Tanii; Junko Kimura; Yuichi Ando
Journal:  Invest New Drugs       Date:  2011-10-01       Impact factor: 3.850

6.  Phase I study of panobinostat and 5-azacitidine in Japanese patients with myelodysplastic syndrome or chronic myelomonocytic leukemia.

Authors:  Yukio Kobayashi; Wataru Munakata; Michinori Ogura; Toshiki Uchida; Masafumi Taniwaki; Tsutomu Kobayashi; Fumika Shimada; Masataka Yonemura; Fumiko Matsuoka; Takeshi Tajima; Kimikazu Yakushijin; Hironobu Minami
Journal:  Int J Hematol       Date:  2017-09-13       Impact factor: 2.490

Review 7.  Trials with 'epigenetic' drugs: an update.

Authors:  Angela Nebbioso; Vincenzo Carafa; Rosaria Benedetti; Lucia Altucci
Journal:  Mol Oncol       Date:  2012-10-06       Impact factor: 6.603

8.  Safety, pharmacokinetics, and pharmacodynamics of panobinostat in children, adolescents, and young adults with relapsed acute myeloid leukemia.

Authors:  Seth E Karol; Todd M Cooper; Paul E Mead; Kristine R Crews; John C Panetta; Thomas B Alexander; Jeffrey W Taub; Norman J Lacayo; Kenneth M Heym; Dennis J Kuo; Deborah E Schiff; Deepa Bhojwani; Yubin Ge; Jeffery M Klco; Raul C Ribeiro; Hiroto Inaba; Ching-Hon Pui; Jeffrey E Rubnitz
Journal:  Cancer       Date:  2020-08-18       Impact factor: 6.860

Review 9.  Targeting Chromatin-Mediated Transcriptional Control of Gene Expression in Non-Small Cell Lung Cancer Therapy: Preclinical Rationale and Clinical Results.

Authors:  Alice Pasini; Angelo Delmonte; Anna Tesei; Daniele Calistri; Emanuele Giordano
Journal:  Drugs       Date:  2015-10       Impact factor: 9.546

10.  Targeting triple-negative breast cancer cells with the histone deacetylase inhibitor panobinostat.

Authors:  Chandra R Tate; Lyndsay V Rhodes; H Chris Segar; Jennifer L Driver; F Nell Pounder; Matthew E Burow; Bridgette M Collins-Burow
Journal:  Breast Cancer Res       Date:  2012-05-21       Impact factor: 6.466

View more

北京卡尤迪生物科技股份有限公司 © 2022-2023.