Evidence map›Paper›PMID 26252788›Full record

Trial reportBlood cancer journal2015

A phase 2 randomized dose-ranging study of the JAK2-selective inhibitor fedratinib (SAR302503) in patients with myelofibrosis.

A Pardanani, A Tefferi, C Jamieson, N Y Gabrail, C Lebedinsky, G Gao, F Liu, C Xu, H Cao, M Talpaz

Open access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Blood cancer journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 1 pooled it
3.8field-weighted citation impact, top 6% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 1 synthesis or guideline pooled it, 96 citations in OpenAlex.

  1. Pooled it
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  19. Disease Modification in Myelofibrosis: An Elusive Goal?Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
    Article
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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

10 authors at 5 institutions in 1 country.

A PardananiDivision of Hematology, Department of Medicine, Mayo Clinic, Rochester, MN, USA.
A TefferiDivision of Hematology, Department of Medicine, Mayo Clinic, Rochester, MN, USA.
C JamiesonDepartment of Medicine, UCSD Moores Cancer Centre, University of California San Diego, La Jolla, CA, USA.
N Y GabrailGabrail Cancer Center, Canton, OH, USA.
C LebedinskySanofi Oncology, Sanofi, Cambridge, MA, USA.
G GaoSanofi Oncology, Sanofi, Cambridge, MA, USA.
F LiuSanofi Oncology, Sanofi, Cambridge, MA, USA.
C XuSanofi Oncology, Sanofi, Cambridge, MA, USA.
H CaoSanofi Oncology, Sanofi, Cambridge, MA, USA.
M TalpazDivision of Hematology-Oncology, Department of Internal Medicine, Comprehensive Cancer Center, The University of Michigan Hospital and Health Systems, Ann Arbor, MI, USA.
Sanofi (United States) · USMayo Clinic in Arizona · USGabrail Cancer Center · USUniversity of California, San Diego · USUniversity of Michigan–Ann Arbor · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In this phase 2 open-label randomized study, 31 patients with intermediate-2 or high-risk myelofibrosis received fedratinib 300, 400 or 500 mg once daily in consecutive 4-week cycles. Mean spleen volume reductions at 12 weeks (primary end point) were 30.3% (300 mg), 33.1% (400 mg) and 43.3% (500 mg). Spleen response rates (patients achieving ⩾35% spleen reduction) at 12/24 weeks were 30%/30% (300 mg), 50%/60% (400 mg) and 64%/55% (500 mg), respectively. By 4 weeks, improvements in myelofibrosis (MF)-associated symptoms were observed. At 48 weeks, 68% of patients remained on fedratinib and 16% had discontinued because of adverse events (AEs). Common grade 3/4 AEs were anemia (58%), fatigue (13%), diarrhea (13%), vomiting (10%) and nausea (6%). Serious AEs included one case of reversible hepatic failure and one case of Wernicke's encephalopathy (after analysis cutoff). Fedratinib treatment led to reduced STAT3 phosphorylation but no meaningful change in JAK2V617F allele burden. Significant modulation (P<0.05, adjusted for multiple comparisons) of 28 cytokines was observed, many of which correlated with spleen reduction. These data confirm the clinical activity of fedratinib in MF. After the analysis cutoff date, additional reports of Wernicke's encephalopathy in other fedratinib trials led to discontinuation of the sponsored clinical development program.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsBenzenesulfonamidesCytokinesDose-Response Relationship, DrugFemaleGene FrequencyHumansJanus Kinase 2MaleMiddle AgedMutation, MissensePrimary MyelofibrosisPyrrolidinesAntineoplastic AgentsBenzenesulfonamidesCytokinesfedratinibJAK2 protein, humanJanus Kinase 2PyrrolidinesSulfonamides

Identifiers

PMID26252788
PMCPMC4558588
OpenAlexW1916256621

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.