Evidence map›Paper›PMID 30958892›Full record

ArticleInternational journal of cancer2019

A phase 1b study evaluating the safety and pharmacokinetics of regorafenib in combination with cetuximab in patients with advanced solid tumors.

Colin Weekes, A Craig Lockhart, James J Lee, Isrid Sturm, Adriaan Cleton, Funan Huang, Heinz-Josef Lenz

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in International journal of cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01973868 (A Phase 1b, Multi-center, Non-randomized, Open Label, Dose Escalation Design Study of Regorafenib), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.5field-weighted citation impact, top 32% 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.

NCT01973868 phase1completednot on this map

A Phase 1b, Multi-center, Non-randomized, Open Label, Dose Escalation Design Study of Regorafenib (BAY73-4506) in Combination With Cetuximab in Subjects With Locally Advanced or Metastatic Solid Tumors Who Are Not Candidates for Standard Therapy or in Whom Regorafenib or Cetuximab is Considered as a Standard Treatment

TypeinterventionalSponsorBayerRan2013 to 2018Enrolled42ConditionsNeoplasmsArmsRegorafenib (Stivarga, BAY73-4506), Cetuximab (ERBITUX)
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 9 citations in OpenAlex.

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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

7 authors at 6 institutions in 2 countries.

Colin WeekesDivision of Hematology/Oncology, Massachusetts General Hospital, Boston, MA.ORCID 0000-0001-6287-4334
A Craig LockhartDepartment of Medicine, University of Miami/Sylvester Comprehensive Cancer Center, Miami, FL.
James J LeeDivision of Hematology-Oncology, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA.
Isrid SturmTranslational Medicine Oncology, Bayer AG, Berlin, Germany.
Adriaan CletonClinical Pharmacology Oncology, Bayer AG, Berlin, Germany.
Funan HuangClinical Pharmacology Oncology, Bayer HealthCare Pharmaceuticals, Whippany, NJ.ORCID 0000-0002-1837-5658
Heinz-Josef LenzDivision of Medical Oncology, University of Southern California/Norris Comprehensive Center, Los Angeles, CA.ORCID 0000-0003-2178-9568
Bayer (Germany) · DEBayer (United States) · USMassachusetts General Hospital · USUniversity of Miami · USUniversity of Pittsburgh · USUniversity of Southern California · US

Funding

Southern California Clinical and Translational Science InstituteUL1TR001855 · NCATS · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Thomas A Buchanan, Michele D. Kipke · 2016 to 2026
$81.3M
NCATS NIH HHS UL1 TR001855
6 · The paper itself

Abstract

Regorafenib 160 mg orally once daily (QD) 3 weeks on/1 week off is approved in colorectal cancer, gastrointestinal stromal tumors and hepatocellular carcinoma. We established the safety and pharmacokinetics (PK) of regorafenib combined with cetuximab in advanced refractory solid tumors. This was a phase 1, open-label, dose-escalation study (NCT01973868) in patients with advanced/metastatic solid tumors who progressed after standard therapy. Regorafenib was administered at various dose levels QD continuously or intermittently (3 weeks on/1 week off) combined with intravenous cetuximab 250 mg/m

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCetuximabDrug InteractionsFemaleHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasmsPhenylurea CompoundsPyridinesTreatment OutcomeYoung AdultCetuximabPhenylurea CompoundsPyridinesregorafenibcetuximabmetastatic colorectal cancerphase 1regorafenib

Identifiers

PMID30958892
PMCPMC6771657
OpenAlexW2938383858

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.