Evidence map›Paper›PMID 25605819›Full record

Trial reportNeuro-oncology2015

Phase II study of PX-866 in recurrent glioblastoma.

Marshall W Pitz, Elizabeth A Eisenhauer, Mary V MacNeil, Brian Thiessen, Jacob C Easaw, David R Macdonald, David D Eisenstat, Ankineedu S Kakumanu, Muhammad Salim, Haji Chalchal and 8 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Neuro-oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01259869 (A Phase II Study of PX-866 in Patients With Glioblastoma Multiforme at Time of First Relapse or Progression), which is not on this map. Cited by 79 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 1 pooled it
6.9field-weighted citation impact, top 2% 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.

NCT01259869 phase2completednot on this map

A Phase II Study of PX-866 in Patients With Glioblastoma Multiforme at Time of First Relapse or Progression

TypeinterventionalSponsorNCIC Clinical Trials GroupRan2011 to 2015Enrolled34ConditionsGlioblastomaArmsPX-866
3 · Its place in the literature

Who cites it

79 citing papers in PubMed, 1 synthesis or guideline pooled it, 119 citations in OpenAlex.

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19 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 1 institution in 1 country.

Marshall W PitzCancerCare Manitoba, Winnipeg, Canada (M.W.P., S.B.); Queen's University, Department of Oncology, Kingston, Canada (E.A.E.); Dalhousie University,Halifax, Canada (M.V.M.); BritishColumbia Cancer Agency, Vancouver, Canada (B.T.); Tom Baker Cancer Centre, Calgary, Canada (J.C.E.); London Regional Cancer Program, London, Canada (D.R.M.); University of Alberta, Edmonton, Canada (D.D.E.); Allan Blair Cancer Center, Regina, Canada (A.S.K., M.S., H.C.); Department of Pathology and Molecular Medicine, Queen's University, Kingston, Canada (J.S.); Department of Pathology, University Health Network, University of Toronto, Toronto, Canada (M.S.T., S.K.-R.); NCIC Clinical Trials Group, Queen's University, Kingston, Canada (D.T., J.P.); Oncothyreon, Inc., Seattle, Washington (D.F.H.); Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada (W.P.M.).
Elizabeth A EisenhauerCancerCare Manitoba, Winnipeg, Canada (M.W.P., S.B.); Queen's University, Department of Oncology, Kingston, Canada (E.A.E.); Dalhousie University,Halifax, Canada (M.V.M.); BritishColumbia Cancer Agency, Vancouver, Canada (B.T.); Tom Baker Cancer Centre, Calgary, Canada (J.C.E.); London Regional Cancer Program, London, Canada (D.R.M.); University of Alberta, Edmonton, Canada (D.D.E.); Allan Blair Cancer Center, Regina, Canada (A.S.K., M.S., H.C.); Department of Pathology and Molecular Medicine, Queen's University, Kingston, Canada (J.S.); Department of Pathology, University Health Network, University of Toronto, Toronto, Canada (M.S.T., S.K.-R.); NCIC Clinical Trials Group, Queen's University, Kingston, Canada (D.T., J.P.); Oncothyreon, Inc., Seattle, Washington (D.F.H.); Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada (W.P.M.).
Mary V MacNeilCancerCare Manitoba, Winnipeg, Canada (M.W.P., S.B.); Queen's University, Department of Oncology, Kingston, Canada (E.A.E.); Dalhousie University,Halifax, Canada (M.V.M.); BritishColumbia Cancer Agency, Vancouver, Canada (B.T.); Tom Baker Cancer Centre, Calgary, Canada (J.C.E.); London Regional Cancer Program, London, Canada (D.R.M.); University of Alberta, Edmonton, Canada (D.D.E.); Allan Blair Cancer Center, Regina, Canada (A.S.K., M.S., H.C.); Department of Pathology and Molecular Medicine, Queen's University, Kingston, Canada (J.S.); Department of Pathology, University Health Network, University of Toronto, Toronto, Canada (M.S.T., S.K.-R.); NCIC Clinical Trials Group, Queen's University, Kingston, Canada (D.T., J.P.); Oncothyreon, Inc., Seattle, Washington (D.F.H.); Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada (W.P.M.).
Brian ThiessenCancerCare Manitoba, Winnipeg, Canada (M.W.P., S.B.); Queen's University, Department of Oncology, Kingston, Canada (E.A.E.); Dalhousie University,Halifax, Canada (M.V.M.); BritishColumbia Cancer Agency, Vancouver, Canada (B.T.); Tom Baker Cancer Centre, Calgary, Canada (J.C.E.); London Regional Cancer Program, London, Canada (D.R.M.); University of Alberta, Edmonton, Canada (D.D.E.); Allan Blair Cancer Center, Regina, Canada (A.S.K., M.S., H.C.); Department of Pathology and Molecular Medicine, Queen's University, Kingston, Canada (J.S.); Department of Pathology, University Health Network, University of Toronto, Toronto, Canada (M.S.T., S.K.-R.); NCIC Clinical Trials Group, Queen's University, Kingston, Canada (D.T., J.P.); Oncothyreon, Inc., Seattle, Washington (D.F.H.); Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada (W.P.M.).
Jacob C EasawCancerCare Manitoba, Winnipeg, Canada (M.W.P., S.B.); Queen's University, Department of Oncology, Kingston, Canada (E.A.E.); Dalhousie University,Halifax, Canada (M.V.M.); BritishColumbia Cancer Agency, Vancouver, Canada (B.T.); Tom Baker Cancer Centre, Calgary, Canada (J.C.E.); London Regional Cancer Program, London, Canada (D.R.M.); University of Alberta, Edmonton, Canada (D.D.E.); Allan Blair Cancer Center, Regina, Canada (A.S.K., M.S., H.C.); Department of Pathology and Molecular Medicine, Queen's University, Kingston, Canada (J.S.); Department of Pathology, University Health Network, University of Toronto, Toronto, Canada (M.S.T., S.K.-R.); NCIC Clinical Trials Group, Queen's University, Kingston, Canada (D.T., J.P.); Oncothyreon, Inc., Seattle, Washington (D.F.H.); Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada (W.P.M.).
David R MacdonaldCancerCare Manitoba, Winnipeg, Canada (M.W.P., S.B.); Queen's University, Department of Oncology, Kingston, Canada (E.A.E.); Dalhousie University,Halifax, Canada (M.V.M.); BritishColumbia Cancer Agency, Vancouver, Canada (B.T.); Tom Baker Cancer Centre, Calgary, Canada (J.C.E.); London Regional Cancer Program, London, Canada (D.R.M.); University of Alberta, Edmonton, Canada (D.D.E.); Allan Blair Cancer Center, Regina, Canada (A.S.K., M.S., H.C.); Department of Pathology and Molecular Medicine, Queen's University, Kingston, Canada (J.S.); Department of Pathology, University Health Network, University of Toronto, Toronto, Canada (M.S.T., S.K.-R.); NCIC Clinical Trials Group, Queen's University, Kingston, Canada (D.T., J.P.); Oncothyreon, Inc., Seattle, Washington (D.F.H.); Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada (W.P.M.).
David D EisenstatCancerCare Manitoba, Winnipeg, Canada (M.W.P., S.B.); Queen's University, Department of Oncology, Kingston, Canada (E.A.E.); Dalhousie University,Halifax, Canada (M.V.M.); BritishColumbia Cancer Agency, Vancouver, Canada (B.T.); Tom Baker Cancer Centre, Calgary, Canada (J.C.E.); London Regional Cancer Program, London, Canada (D.R.M.); University of Alberta, Edmonton, Canada (D.D.E.); Allan Blair Cancer Center, Regina, Canada (A.S.K., M.S., H.C.); Department of Pathology and Molecular Medicine, Queen's University, Kingston, Canada (J.S.); Department of Pathology, University Health Network, University of Toronto, Toronto, Canada (M.S.T., S.K.-R.); NCIC Clinical Trials Group, Queen's University, Kingston, Canada (D.T., J.P.); Oncothyreon, Inc., Seattle, Washington (D.F.H.); Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada (W.P.M.).
Ankineedu S KakumanuCancerCare Manitoba, Winnipeg, Canada (M.W.P., S.B.); Queen's University, Department of Oncology, Kingston, Canada (E.A.E.); Dalhousie University,Halifax, Canada (M.V.M.); BritishColumbia Cancer Agency, Vancouver, Canada (B.T.); Tom Baker Cancer Centre, Calgary, Canada (J.C.E.); London Regional Cancer Program, London, Canada (D.R.M.); University of Alberta, Edmonton, Canada (D.D.E.); Allan Blair Cancer Center, Regina, Canada (A.S.K., M.S., H.C.); Department of Pathology and Molecular Medicine, Queen's University, Kingston, Canada (J.S.); Department of Pathology, University Health Network, University of Toronto, Toronto, Canada (M.S.T., S.K.-R.); NCIC Clinical Trials Group, Queen's University, Kingston, Canada (D.T., J.P.); Oncothyreon, Inc., Seattle, Washington (D.F.H.); Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada (W.P.M.).
Muhammad SalimCancerCare Manitoba, Winnipeg, Canada (M.W.P., S.B.); Queen's University, Department of Oncology, Kingston, Canada (E.A.E.); Dalhousie University,Halifax, Canada (M.V.M.); BritishColumbia Cancer Agency, Vancouver, Canada (B.T.); Tom Baker Cancer Centre, Calgary, Canada (J.C.E.); London Regional Cancer Program, London, Canada (D.R.M.); University of Alberta, Edmonton, Canada (D.D.E.); Allan Blair Cancer Center, Regina, Canada (A.S.K., M.S., H.C.); Department of Pathology and Molecular Medicine, Queen's University, Kingston, Canada (J.S.); Department of Pathology, University Health Network, University of Toronto, Toronto, Canada (M.S.T., S.K.-R.); NCIC Clinical Trials Group, Queen's University, Kingston, Canada (D.T., J.P.); Oncothyreon, Inc., Seattle, Washington (D.F.H.); Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada (W.P.M.).
Haji ChalchalCancerCare Manitoba, Winnipeg, Canada (M.W.P., S.B.); Queen's University, Department of Oncology, Kingston, Canada (E.A.E.); Dalhousie University,Halifax, Canada (M.V.M.); BritishColumbia Cancer Agency, Vancouver, Canada (B.T.); Tom Baker Cancer Centre, Calgary, Canada (J.C.E.); London Regional Cancer Program, London, Canada (D.R.M.); University of Alberta, Edmonton, Canada (D.D.E.); Allan Blair Cancer Center, Regina, Canada (A.S.K., M.S., H.C.); Department of Pathology and Molecular Medicine, Queen's University, Kingston, Canada (J.S.); Department of Pathology, University Health Network, University of Toronto, Toronto, Canada (M.S.T., S.K.-R.); NCIC Clinical Trials Group, Queen's University, Kingston, Canada (D.T., J.P.); Oncothyreon, Inc., Seattle, Washington (D.F.H.); Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada (W.P.M.).
Jeremy SquireCancerCare Manitoba, Winnipeg, Canada (M.W.P., S.B.); Queen's University, Department of Oncology, Kingston, Canada (E.A.E.); Dalhousie University,Halifax, Canada (M.V.M.); BritishColumbia Cancer Agency, Vancouver, Canada (B.T.); Tom Baker Cancer Centre, Calgary, Canada (J.C.E.); London Regional Cancer Program, London, Canada (D.R.M.); University of Alberta, Edmonton, Canada (D.D.E.); Allan Blair Cancer Center, Regina, Canada (A.S.K., M.S., H.C.); Department of Pathology and Molecular Medicine, Queen's University, Kingston, Canada (J.S.); Department of Pathology, University Health Network, University of Toronto, Toronto, Canada (M.S.T., S.K.-R.); NCIC Clinical Trials Group, Queen's University, Kingston, Canada (D.T., J.P.); Oncothyreon, Inc., Seattle, Washington (D.F.H.); Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada (W.P.M.).
Ming Sound TsaoCancerCare Manitoba, Winnipeg, Canada (M.W.P., S.B.); Queen's University, Department of Oncology, Kingston, Canada (E.A.E.); Dalhousie University,Halifax, Canada (M.V.M.); BritishColumbia Cancer Agency, Vancouver, Canada (B.T.); Tom Baker Cancer Centre, Calgary, Canada (J.C.E.); London Regional Cancer Program, London, Canada (D.R.M.); University of Alberta, Edmonton, Canada (D.D.E.); Allan Blair Cancer Center, Regina, Canada (A.S.K., M.S., H.C.); Department of Pathology and Molecular Medicine, Queen's University, Kingston, Canada (J.S.); Department of Pathology, University Health Network, University of Toronto, Toronto, Canada (M.S.T., S.K.-R.); NCIC Clinical Trials Group, Queen's University, Kingston, Canada (D.T., J.P.); Oncothyreon, Inc., Seattle, Washington (D.F.H.); Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada (W.P.M.).
Suzanne Kamel-ReidCancerCare Manitoba, Winnipeg, Canada (M.W.P., S.B.); Queen's University, Department of Oncology, Kingston, Canada (E.A.E.); Dalhousie University,Halifax, Canada (M.V.M.); BritishColumbia Cancer Agency, Vancouver, Canada (B.T.); Tom Baker Cancer Centre, Calgary, Canada (J.C.E.); London Regional Cancer Program, London, Canada (D.R.M.); University of Alberta, Edmonton, Canada (D.D.E.); Allan Blair Cancer Center, Regina, Canada (A.S.K., M.S., H.C.); Department of Pathology and Molecular Medicine, Queen's University, Kingston, Canada (J.S.); Department of Pathology, University Health Network, University of Toronto, Toronto, Canada (M.S.T., S.K.-R.); NCIC Clinical Trials Group, Queen's University, Kingston, Canada (D.T., J.P.); Oncothyreon, Inc., Seattle, Washington (D.F.H.); Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada (W.P.M.).
Shantanu BanerjiCancerCare Manitoba, Winnipeg, Canada (M.W.P., S.B.); Queen's University, Department of Oncology, Kingston, Canada (E.A.E.); Dalhousie University,Halifax, Canada (M.V.M.); BritishColumbia Cancer Agency, Vancouver, Canada (B.T.); Tom Baker Cancer Centre, Calgary, Canada (J.C.E.); London Regional Cancer Program, London, Canada (D.R.M.); University of Alberta, Edmonton, Canada (D.D.E.); Allan Blair Cancer Center, Regina, Canada (A.S.K., M.S., H.C.); Department of Pathology and Molecular Medicine, Queen's University, Kingston, Canada (J.S.); Department of Pathology, University Health Network, University of Toronto, Toronto, Canada (M.S.T., S.K.-R.); NCIC Clinical Trials Group, Queen's University, Kingston, Canada (D.T., J.P.); Oncothyreon, Inc., Seattle, Washington (D.F.H.); Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada (W.P.M.).
Dongsheng TuCancerCare Manitoba, Winnipeg, Canada (M.W.P., S.B.); Queen's University, Department of Oncology, Kingston, Canada (E.A.E.); Dalhousie University,Halifax, Canada (M.V.M.); BritishColumbia Cancer Agency, Vancouver, Canada (B.T.); Tom Baker Cancer Centre, Calgary, Canada (J.C.E.); London Regional Cancer Program, London, Canada (D.R.M.); University of Alberta, Edmonton, Canada (D.D.E.); Allan Blair Cancer Center, Regina, Canada (A.S.K., M.S., H.C.); Department of Pathology and Molecular Medicine, Queen's University, Kingston, Canada (J.S.); Department of Pathology, University Health Network, University of Toronto, Toronto, Canada (M.S.T., S.K.-R.); NCIC Clinical Trials Group, Queen's University, Kingston, Canada (D.T., J.P.); Oncothyreon, Inc., Seattle, Washington (D.F.H.); Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada (W.P.M.).
Jean PowersCancerCare Manitoba, Winnipeg, Canada (M.W.P., S.B.); Queen's University, Department of Oncology, Kingston, Canada (E.A.E.); Dalhousie University,Halifax, Canada (M.V.M.); BritishColumbia Cancer Agency, Vancouver, Canada (B.T.); Tom Baker Cancer Centre, Calgary, Canada (J.C.E.); London Regional Cancer Program, London, Canada (D.R.M.); University of Alberta, Edmonton, Canada (D.D.E.); Allan Blair Cancer Center, Regina, Canada (A.S.K., M.S., H.C.); Department of Pathology and Molecular Medicine, Queen's University, Kingston, Canada (J.S.); Department of Pathology, University Health Network, University of Toronto, Toronto, Canada (M.S.T., S.K.-R.); NCIC Clinical Trials Group, Queen's University, Kingston, Canada (D.T., J.P.); Oncothyreon, Inc., Seattle, Washington (D.F.H.); Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada (W.P.M.).
Diana F HausmanCancerCare Manitoba, Winnipeg, Canada (M.W.P., S.B.); Queen's University, Department of Oncology, Kingston, Canada (E.A.E.); Dalhousie University,Halifax, Canada (M.V.M.); BritishColumbia Cancer Agency, Vancouver, Canada (B.T.); Tom Baker Cancer Centre, Calgary, Canada (J.C.E.); London Regional Cancer Program, London, Canada (D.R.M.); University of Alberta, Edmonton, Canada (D.D.E.); Allan Blair Cancer Center, Regina, Canada (A.S.K., M.S., H.C.); Department of Pathology and Molecular Medicine, Queen's University, Kingston, Canada (J.S.); Department of Pathology, University Health Network, University of Toronto, Toronto, Canada (M.S.T., S.K.-R.); NCIC Clinical Trials Group, Queen's University, Kingston, Canada (D.T., J.P.); Oncothyreon, Inc., Seattle, Washington (D.F.H.); Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada (W.P.M.).
Warren P MasonCancerCare Manitoba, Winnipeg, Canada (M.W.P., S.B.); Queen's University, Department of Oncology, Kingston, Canada (E.A.E.); Dalhousie University,Halifax, Canada (M.V.M.); BritishColumbia Cancer Agency, Vancouver, Canada (B.T.); Tom Baker Cancer Centre, Calgary, Canada (J.C.E.); London Regional Cancer Program, London, Canada (D.R.M.); University of Alberta, Edmonton, Canada (D.D.E.); Allan Blair Cancer Center, Regina, Canada (A.S.K., M.S., H.C.); Department of Pathology and Molecular Medicine, Queen's University, Kingston, Canada (J.S.); Department of Pathology, University Health Network, University of Toronto, Toronto, Canada (M.S.T., S.K.-R.); NCIC Clinical Trials Group, Queen's University, Kingston, Canada (D.T., J.P.); Oncothyreon, Inc., Seattle, Washington (D.F.H.); Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada (W.P.M.).
Cancer Care Ontario · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGlioblastoma (GBM) is the most aggressive malignancy of the central nervous system in adults. Increased activity of the phosphatidylinositol-3-OH kinase (PI3K) signal transduction pathway is common. We performed a phase II study using PX-866, an oral PI3K inhibitor, in participants with recurrent GBM.

methodsPatients with histologically confirmed GBM at first recurrence were given oral PX-866 at a dose of 8 mg daily. An MRI and clinical exam were done every 8 weeks. Tissue was analyzed for potential predictive markers.

resultsThirty-three participants (12 female) were enrolled. Median age was 56 years (range 35-78y). Eastern Cooperative Oncology Group performance status was 0-1 in 29 participants and 2 in the remainder. Median number of cycles was 1 (range 1-8). All participants have discontinued therapy: 27 for disease progression and 6 for toxicity (5 liver enzymes and 1 allergic reaction). Four participants had treatment-related serious adverse events (1 liver enzyme, 1 diarrhea, 2 venous thromboembolism). Other adverse effects included fatigue, diarrhea, nausea, vomiting, and lymphopenia. Twenty-four participants had a response of progression (73%), 1 had partial response (3%, and 8 (24%) had stable disease (median, 6.3 months; range, 3.1-16.8 months). Median 6-month progression-free survival was 17%. None of the associations between stable disease and PTEN, PIK3CA, PIK3R1, or EGFRvIII status were statistically significant.

conclusionsPX-866 was relatively well tolerated. Overall response rate was low, and the study did not meet its primary endpoint; however, 21% of participants obtained durable stable disease. This study also failed to identify a statistically significant association between clinical outcome and relevant biomarkers in patients with available tissue.

Indexed as

Administration, OralAdultAgedAntineoplastic AgentsBrain NeoplasmsFemaleGlioblastomaGonanesHumansMaleMiddle AgedPhosphoinositide-3 Kinase InhibitorsTreatment OutcomeAntineoplastic AgentsGonanesPhosphoinositide-3 Kinase InhibitorsPX-866clinical trialglioblastomaPI3K

Identifiers

PMID25605819
PMCPMC4588751
OpenAlexW2320193046

What OpenQuestion holds

Textmetadata
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.