Evidence map›Paper›PMID 33993383›Full record

ArticleCancer chemotherapy and pharmacology2021

Phase 1 study of alisertib (MLN8237) and weekly irinotecan in adults with advanced solid tumors.

Thomas J Semrad, Edward J Kim, I-Yeh Gong, Tianhong Li, Scott Christensen, Mili Arora, Jonathan W Riess, David R Gandara, Karen Kelly

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

Article in Cancer chemotherapy and pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01923337 (Phase I Study of the Combination of Irinotecan and MLN8237 in Advanced Solid Tumors With Emphasis on Colorectal Cancer), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.0field-weighted citation impact, top 29% 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.

NCT01923337 phase1completednot on this map

Phase I Study of the Combination of Irinotecan and MLN8237 in Advanced Solid Tumors With Emphasis on Colorectal Cancer

TypeinterventionalSponsorUniversity of California, DavisRan2013 to 2016Enrolled17ConditionsMucinous Adenocarcinoma of the Colon, Mucinous Adenocarcinoma of the Rectum, Recurrent Colon Cancer, Recurrent Rectal CancerArmsirinotecan hydrochloride, alisertib
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Targeting Myc-driven stress addiction in colorectal cancer.Drug resistance updates : reviews and commentaries in antimicrobial and anticancer chemotherapy · 2023
    Review
  9. Article
  10. Review
  11. 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 3 institutions in 1 country.

Thomas J SemradGene Upshaw Memorial Tahoe Forest Cancer Center, 10121 Pine Avenue, Truckee, CA, USA. tsemrad@tfhd.com.ORCID 0000-0002-7810-5887
Edward J KimDivision of Hematology/Oncology, University of California, Davis Comprehensive Cancer Center, Sacramento, CA, USA.
I-Yeh GongDivision of Hematology/Oncology, University of California, Davis Comprehensive Cancer Center, Sacramento, CA, USA.
Tianhong LiDivision of Hematology/Oncology, University of California, Davis Comprehensive Cancer Center, Sacramento, CA, USA.
Scott ChristensenDivision of Hematology/Oncology, University of California, Davis Comprehensive Cancer Center, Sacramento, CA, USA.
Mili AroraDivision of Hematology/Oncology, University of California, Davis Comprehensive Cancer Center, Sacramento, CA, USA.
Jonathan W RiessDivision of Hematology/Oncology, University of California, Davis Comprehensive Cancer Center, Sacramento, CA, USA.
David R GandaraDivision of Hematology/Oncology, University of California, Davis Comprehensive Cancer Center, Sacramento, CA, USA.
Karen KellyDivision of Hematology/Oncology, University of California, Davis Comprehensive Cancer Center, Sacramento, CA, USA.
UC Davis Comprehensive Cancer CenterKaiser Permanente · USTahoe Forest Hospital · US

Funding

Staff InvestigatorsP30CA093373 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI Gina M Dayton · 2002 to 2026
$84.9M
UC Davis Paul Calabresi K12 Clinical Oncology Research Career Development ProgramK12CA138464 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI BIRKELAND, ANDREW CHARLES, LARA, PRIMO N. · 2011 to 2025
$11.4M
NCI NIH HHS K12 CA138464NCI NIH HHS P30 CA093373
6 · The paper itself

Abstract

purposeAurora kinases are overexpressed or amplified in numerous malignancies. This study was designed to determine the safety and tolerability of the Aurora A kinase inhibitor alisertib (MLN8237) when combined with weekly irinotecan.

methodsIn this single-center phase 1 study, adult patients with refractory advanced solid tumors received 100 mg/m

resultsA total of 17 patients enrolled at three dose levels. Dose-limiting toxicities included diarrhea, dehydration, and neutropenia. The MTD of alisertib combined with weekly irinotecan was 20 mg twice per day on days 1-3 and 8-10. One fatal cardiac arrest at the highest dose level tested was deemed possibly related to drug treatment. One partial response in 11 efficacy evaluable patients (9%) occurred in a patient with small cell lung cancer. The study was terminated prior to the planned expansion in patients with colorectal cancer.

conclusionIn contrast to prior results in a pediatric population, adult patients did not tolerate alisertib combined with irinotecan at clinically meaningful doses due to hematologic and gastrointestinal toxicities. The study was registered with ClinicalTrials.gov under study number NCT01923337 on Aug 15, 2013.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsAzepinesCohort StudiesDrug Administration ScheduleFemaleHumansIrinotecanMaleMaximum Tolerated DoseMiddle AgedNeoplasmsProtein Kinase InhibitorsPyrimidinesAzepinesIrinotecanMLN 8237Protein Kinase InhibitorsPyrimidinesAlisertibAurora kinase AIrinotecanPhase I

Identifiers

PMID33993383
PMCPMC8259450
OpenAlexW3160572483

What OpenQuestion holds

Textmetadata
LicenceTDM
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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.