Evidence map›Paper›PMID 31506897›Full record

ArticleInvestigational new drugs2020

A phase Ib study of a PI3Kinase inhibitor BKM120 in combination with panitumumab in patients with KRAS wild-type advanced colorectal cancer.

Rachel Goodwin, Derek Jonker, Eric Chen, Hagen Kennecke, Michael Cabanero, Ming-Sound Tsao, Michael Vickers, Caryn Bohemier, Howard Lim, Heather Ritter and 2 more

Registry-linked trialAbstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Investigational new drugs, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01591421 (Phase I/II Study of the P13Kinase Inhibitor BKM120 Given in Combination With Panitumumab in Patients With Metastatic or Advanced RAS-Wild Type Colorectal Cancer.), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
1.2field-weighted citation impact, top 19% 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.

NCT01591421 phase1 / phase2completednot on this map

Phase I/II Study of the P13Kinase Inhibitor BKM120 Given in Combination With Panitumumab in Patients With Metastatic or Advanced RAS-Wild Type Colorectal Cancer.

TypeinterventionalSponsorCanadian Cancer Trials GroupRan2012 to 2019Enrolled22ConditionsMetastatic Colorectal CancerArmsBKM120, Panitumumab
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 23 citations in OpenAlex.

  1. Review
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  6. Targeted Treatment against Cancer Stem Cells in Colorectal Cancer.International journal of molecular sciences · 2024
    Review
  7. PI3K/Akt/mTOR Signaling Pathway as a Target for Colorectal Cancer Treatment.International journal of molecular sciences · 2024
    Review
  8. Review
  9. Article
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  12. Cell line models for drug discovery in PIK3CA-mutated colorectal cancers.Medical oncology (Northwood, London, England) · 2022
    Article
  13. Review
  14. Article
  15. Review
  16. Article
  17. PI3K Inhibitors in Cancer: Clinical Implications and Adverse Effects.International journal of molecular sciences · 2021
    Review
  18. Review
  19. Review
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

12 authors at 6 institutions in 2 countries.

Rachel GoodwinOttawa Hospital Research Institute, The Ottawa Hospital Cancer Centre, University of Ottawa, Ottawa, ON, K1H 8L6, Canada. rgoodwin@toh.on.ca.
Derek JonkerOttawa Hospital Research Institute, The Ottawa Hospital Cancer Centre, University of Ottawa, Ottawa, ON, K1H 8L6, Canada.
Eric ChenPrincess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Hagen KenneckeVirginia Mason Cancer Institute, Seattle, WA, USA.
Michael CabaneroDepartment of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.
Ming-Sound TsaoDepartment of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.
Michael VickersOttawa Hospital Research Institute, The Ottawa Hospital Cancer Centre, University of Ottawa, Ottawa, ON, K1H 8L6, Canada.
Caryn BohemierOttawa Hospital Research Institute, The Ottawa Hospital Cancer Centre, University of Ottawa, Ottawa, ON, K1H 8L6, Canada.
Howard LimBCCA-Vancouver Centre, Vancouver, BC, Canada.
Heather RitterCanadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.
Dongsheng TuCanadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.
Lesley SeymourCanadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.
Queen's University · CAOttawa Hospital · CAUniversity of Ottawa · CAUniversity of Toronto · CAPrincess Margaret Cancer Centre · CAVirginia Mason Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background Resistance to Epidermal Growth Factor inhibition (EGFRi) in patients with KRAS wild-type (wt) Colorectal Cancer (CRC) may occur as a result of PI3K/AKT/mTOR signaling. We conducted a study to establish the recommended phase II dose (RP2D) and response rate of panitumumab, an EGFRi, plus BKM120, a PI3K inhibitor, in advanced CRC. Methods Patients with chemotherapy refractory KRAS wt CRC, who were EGFRi naive were enrolled. A 3 + 3 dose escalation design was utilized. The starting dose of panitumumab was 6 mg/kg iv every 2 weeks with BKM120 at 60 mg oral daily. Results Nineteen patients were treated and 17 were evaluable for response. The starting dose was not tolerable (mucositis, fatigue). At dose level (DL) 1, three of six patients discontinued treatment due to toxicity, DL - 1 had no significant toxicity. Panitumumab 6 mg/kg iv q 2 weeks with BKM120 60 mg given 5 out of 7 days per week was declared the RP2D. One patient (5.9%) who was PTEN and PIK3CA negative by IHC had a partial response, seven had stable disease, and nine had disease progression. Conclusion Panitumumab (6 mg/kg iv q 2 weeks) with BKM120 60 mg given 5 out of 7 days per week was declared the RP2D. Toxicities including fatigue, rash and mucositis. There was little evidence of activity in this biomarker unselected cohort.

Indexed as

AgedAged, 80 and overAminopyridinesAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorColorectal NeoplasmsExanthemaFatigueFemaleHumansMaleMiddle AgedMorpholinesMucositisPanitumumabAminopyridinesAntineoplastic AgentsBiomarkers, TumorKRAS protein, humanMorpholinesNVP-BKM120PanitumumabPhosphatidylinositol 3-KinasesPhosphoinositide-3 Kinase InhibitorsProto-Oncogene Proteins p21(ras)PTEN PhosphohydrolasePTEN protein, humanBKM120Metastatic colon cancerPanitumumabPhase 1

Identifiers

PMID31506897
OpenAlexW2972912130

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.