Evidence map›Paper›PMID 23857959›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2013

A phase I/II study of sepantronium bromide (YM155, survivin suppressor) with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer.

R J Kelly, A Thomas, A Rajan, G Chun, A Lopez-Chavez, E Szabo, S Spencer, C A Carter, U Guha, S Khozin and 6 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01100931 (A Phase I/II Study of Paclitaxel, Carboplatin and YM155), which is not on this map. Cited by 91 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
91citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01100931 phase1 / phase2completednot on this map

A Phase I/II Study of Paclitaxel, Carboplatin and YM155 (Survivin Suppressor) in Subjects With Solid Tumors (Phase I) and Advanced Non-Small Cell Lung Carcinoma (Phase II)

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2010 to 2012Enrolled42ConditionsNSCLC, Solid TumorsArmsYM155, Carboplatin, Paclitaxel
3 · Its place in the literature

Who cites it

91 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  3. Pandora's Box of AML: HowBiomedicines · 2025
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31 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

R J KellyThe Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins, Baltimore.
A ThomasMedical Oncology Branch, Center for Cancer Research.
A RajanMedical Oncology Branch, Center for Cancer Research.
G ChunMedical Oncology Branch, Center for Cancer Research.
A Lopez-ChavezMedical Oncology Branch, Center for Cancer Research.
E SzaboLung and Upper Aerodigestive Cancer Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda.
S SpencerMedical Oncology Branch, Center for Cancer Research.
C A CarterMedical Oncology, Walter Reed National Military Medical Center, Bethesda.
U GuhaMedical Oncology Branch, Center for Cancer Research.
S KhozinMedical Oncology Branch, Center for Cancer Research.
S PoondruAstellas Pharma Global Development, Northbrook.
C Van SantAstellas Pharma Global Development, Northbrook.
A KeatingAstellas Pharma Global Development, Northbrook.
S M SteinbergBiostatistics and Data Management Section, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute, Bethesda, USA.
W FiggMedical Oncology Branch, Center for Cancer Research.
G GiacconeMedical Oncology Branch, Center for Cancer Research. Electronic address: giacconeg@mail.nih.gov.

Funding

Using Clinical Pharmacology Principles to Develop New Anticancer TherapiesZICSC006537 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2009 to 2025
$14.4M
Intramural NIH HHS
6 · The paper itself

Abstract

backgroundThis 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). PATIENTS AND

methodsForty-one patients were treated on study. Twenty-two patients received escalating doses of S (3.6-12 mg/m(2)) and 19 with untreated stage IV non-small-cell lung cancer (NSCLC) were treated with the maximum tolerated dose of 10 mg/m(2) in combination with standard doses of C (AUC6) and P (200 mg/m(2)) 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.

resultsTreatment 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.

conclusionThe combination of S (10 mg/m(2)/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. CLINICAL TRIAL NUMBER: NCT01100931.

Indexed as

AdultAgedAntineoplastic Agents, PhytogenicAntineoplastic Combined Chemotherapy ProtocolsApoptosisCarboplatinCarcinoma, Non-Small-Cell LungDisease-Free SurvivalFemaleHumansImidazolesInhibitor of Apoptosis ProteinsLung NeoplasmsMaleMiddle AgedNaphthoquinonesAntineoplastic Agents, PhytogenicBIRC5 protein, humanCarboplatinImidazolesInhibitor of Apoptosis ProteinsNaphthoquinonesPaclitaxelsepantroniumSurvivinapoptosisnon-small-cell lung cancersepantronium bromidesurvivin

Identifiers

PMID23857959
PMCPMC3784336

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.