Evidence map›Paper›PMID 21924492›Full record

Trial reportLeukemia research2012

Treatment of higher risk myelodysplastic syndrome patients unresponsive to hypomethylating agents with ON 01910.Na.

Mahesh Seetharam, Alice C Fan, Mai Tran, Liwen Xu, John P Renschler, Dean W Felsher, Kunju Sridhar, Francois Wilhelm, Peter L Greenberg

6 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Leukemia research, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
4.9field-weighted citation impact, top 4% 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.

NCT00854646 phase1completednot on this map

Phase I Dose Escalation Study of ON 01910.Na With Increasing Duration of an Initial 3-Day Continuous Infusion in Patients With Refractory Leukemia or MDS

TypeinterventionalSponsorTraws Pharma, Inc.Ran2008 to 2015Enrolled22ConditionsAcute Myelocytic Leukemia, Acute Lymphocytic Leukemia, Chronic Myelocytic Leukemia, Chronic Lymphocytic LeukemiaArmsON 01910.Na
NCT00854945 phase1 / phase2completednot on this map

A Phase 1/2, Single-Arm Study To Assess The Efficacy and Safety Of 72-Hour Continuous Intravenous Dosing Of ON 01910.Na Administered Every Other Week in Patients With Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML)

TypeinterventionalSponsorTraws Pharma, Inc.Ran2009 to 2014Enrolled36ConditionsMyelodysplastic Syndrome, Acute Myeloid LeukemiaArmsON 01910.Na
NCT00906334 phase2completednot on this map

A Phase 2, Single-Arm Study To Assess The Efficacy and Safety Of 72-Hour Continuous Intravenous Dosing Of ON 01910.Na Administered Every Other Week in Myelodysplastic Syndrome Patients With Trisomy 8 or Classified as Intermediate-1, 2 or High Risk

TypeinterventionalSponsorTraws Pharma, Inc.Ran2009 to 2013Enrolled14ConditionsMyelodysplastic SyndromeArmsON 01910.Na
NCT01241500 phase3completednot on this map

Phase III MultiCenter Randomized Controlled Study to Assess Efficacy and Safety of ON 01910.Na 72-Hr Continuous IV Infusion in MDS Patients With Excess Blasts Relapsing After or Refractory to or Intolerant to Azacitidine or Decitabine

TypeinterventionalSponsorTraws Pharma, Inc.Ran2010 to 2018Enrolled299ConditionsMyelodysplastic Syndromes, MDS, RAEB, Chronic Myelomonocytic LeukemiaArmsON 01910.Na
NCT01904682 phase2completednot on this mapstarted 2013, after this paper: background citation

A Single-arm Study to Assess the Efficacy and Safety of Oral Rigosertib in Transfusion-dependent, Low or Intermediate-1, Myelodysplastic Syndrome Patients Based on the International Prognostic Scoring System

TypeinterventionalSponsorTraws Pharma, Inc.Ran2013 to 2021Enrolled45ConditionsMyelodysplastic SyndromesArmsOral rigosertib
NCT01928537 phase3completednot on this mapstarted 2013, after this paper: background citation

Phase IIIB, Open-label, Multi-Center Study of the Efficacy and Safety of Rigosertib Administered as 72-hour Continuous Intravenous Infusions in Patients With Myelodysplastic Syndrome With Excess Blasts Progressing On or After Azacitidine or Decitabine

TypeinterventionalSponsorTraws Pharma, Inc.Ran2013 to 2017Enrolled67ConditionsMyelodysplastic Syndromes, Refractory Anemia With Excess Blasts, Chronic Myelomonocytic Leukemia, CytopeniaArmsrigosertib sodium
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 54 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Review
  6. Review
  7. Review
  8. Incorporating novel approaches in the management of MDS beyond conventional hypomethylating agents.Hematology. American Society of Hematology. Education Program · 2017
    Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Outlook on PI3K/AKT/mTOR inhibition in acute leukemia.Molecular and cellular therapies · 2015
    Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Article
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

9 authors at 2 institutions in 1 country.

Mahesh SeetharamDepartment of Medicine (Hematology), Stanford University Cancer Center, Stanford, CA, USA.
Alice C Fan
Mai Tran
Liwen Xu
John P Renschler
Dean W Felsher
Kunju Sridhar
Francois Wilhelm
Peter L Greenberg
Stanford University · USOnconova Therapeutics (United States) · US

Funding

Spectrum Stanford Center for clinical and Translational Research and EducationUL1TR001085 · NCATS · STANFORD UNIVERSITY · PI CULLEN, MARK RICHARD, GREENBERG, HARRY BERNARD · 2013 to 2017
$37.1M
Stanford Center for Clinical and Translational Education and Research (SCCTER)UL1UL1RR025744 · NCRR · STANFORD UNIVERSITY · PI GREENBERG, HARRY BERNARD · 2008 to 2011
$22.4M
TRIGGERING CELL DEATH IN B CELL LYMPHOMAP01CA034233 · NCI · STANFORD UNIVERSITY · PI LEVY, RONALD · 1985 to 2010
$19.5M
Pilot ProjectsU54CA151459 · NCI · STANFORD UNIVERSITY · PI GAMBHIR, SANJIV S · 2010 to 2014
$12.6M
MODELING THE ROLE OF PROGRESSION IN FOLLICULAR LYMPHOMAU54CA149145 · NCI · STANFORD UNIVERSITY · PI PLEVRITIS, SYLVIA KATINA · 2010 to 2014
$12.1M
Nanoscale analysis of proteomic response to novel targeted therapies for lymphomaK23CA140722 · NCI · STANFORD UNIVERSITY · PI FAN, ALICE CHEN · 2010 to 2014
$867k
NCATS NIH HHS UL1 TR001085NCI NIH HHS K23 CA140722NCI NIH HHS P01 CA034233NCI NIH HHS U54 CA149145NCI NIH HHS U54 CA151459NCRR NIH HHS 1UL1 RR025744 FORNCRR NIH HHS UL1 RR025744
6 · The paper itself

Abstract

In a Phase I/II clinical trial, 13 higher risk red blood cell-dependent myelodysplastic syndrome (MDS) patients unresponsive to hypomethylating therapy were treated with the multikinase inhibitor ON 01910.Na. Responses occurred in all morphologic, prognostic risk and cytogenetic subgroups, including four patients with marrow complete responses among eight with stable disease, associated with good drug tolerance. In a subset of patients, a novel nanoscale immunoassay showed substantially decreased AKT2 phosphorylation in CD34+ marrow cells from patients responding to therapy but not those who progressed on therapy. These data demonstrate encouraging efficacy and drug tolerance with ON 01910.Na treatment of higher risk MDS patients.

Indexed as

AgedAged, 80 and overAntineoplastic AgentsDNA (Cytosine-5-)-Methyltransferase 1DNA (Cytosine-5-)-MethyltransferasesDNA MethylationDrug Resistance, NeoplasmEnzyme InhibitorsFemaleGlycineHumansMaleMyelodysplastic SyndromesRiskSulfonesSurvival AnalysisAntineoplastic AgentsDNA (Cytosine-5-)-Methyltransferase 1DNA (Cytosine-5-)-MethyltransferasesEnzyme InhibitorsGlycineON 01910Sulfones

Identifiers

PMID21924492
PMCPMC3612532
OpenAlexW2038250293

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.