Journal article
A phase I/II study of sepantronium bromide (YM155, survivin suppressor) with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer
Annals of oncology, Vol.24(10), pp.2601-2606
01 Oct 2013
PMID: 23857959
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
This phase I/II study examined the safety and efficacy of Sepantronium Bromide (S), a small-molecule selective survivin suppressant, administered in combination with carboplatin (C) and paclitaxel (P).
Forty-one patients were treated on study. Twenty-two patients received escalating doses of S (3.6–12 mg/m2) and 19 with untreated stage IV non-small-cell lung cancer (NSCLC) were treated with the maximum tolerated dose of 10 mg/m2 in combination with standard doses of C (AUC6) and P (200 mg/m2) for six cycles. S was administered as a continuous intravenous infusion (CIVI) over 72 h in 21-day treatment cycles. Study end points included safety and toxic effect, response rate, progression-free and overall survival (PFS and OS), as well as exploratory pharmacodynamic correlates.
Treatment with S was well tolerated, and toxic effects were mostly hematological in the phase II study. Two (11%) partial responses were observed with a median PFS of 5.7 months and median OS 16.1 months. Pharmacodynamic analysis did not demonstrate an association with response.
The combination of S (10 mg/m2/day 72-h CIVI) administered with C and P every 3 weeks exhibited a favorable safety profile but failed to demonstrate an improvement in response rate in advanced NSCLC.
NCT01100931.
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Details
- Title
- A phase I/II study of sepantronium bromide (YM155, survivin suppressor) with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer
- Creators
- R.J. Kelly - Sidney Kimmel Comprehensive Cancer CenterA. Thomas - Center for Cancer ResearchA. Rajan - Center for Cancer ResearchG. Chun - Center for Cancer ResearchA. Lopez-Chavez - Center for Cancer ResearchE. Szabo - National Cancer InstituteS. Spencer - Center for Cancer ResearchC.A. Carter - Walter Reed National Military Medical CenterU. Guha - Center for Cancer ResearchS. Khozin - Center for Cancer ResearchS. Poondru - Center for Global DevelopmentC. Van Sant - Center for Global DevelopmentA. Keating - Center for Global DevelopmentS.M. Steinberg - National Cancer InstituteW. Figg - Center for Cancer ResearchG. Giaccone - Center for Cancer Research
- Publication Details
- Annals of oncology, Vol.24(10), pp.2601-2606
- Publisher
- Elsevier
- Number of pages
- 6
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- General Internal Medicine
- Web of Science ID
- WOS:000325153800023
- Scopus ID
- 2-s2.0-84884717482
- Other Identifier
- 991022059860304721
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- Web of Science research areas
- Oncology