Evidence map›Paper›PMID 38103947›Full record

ArticleClinical colorectal cancer2024

A Phase 1 Study of Cabozantinib and Trifluridine/Tipiracil in Metastatic Colorectal Adenocarcinoma.

Farshid Dayyani, Jasmine Balangue, Jennifer Valerin, Matthew J Keating, Jason A Zell, Thomas H Taylor, May T Cho

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical colorectal cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04868773 (A Phase 1 Study of the Combination of Cabozantinib With Trifluridine/Tipiracil), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.2field-weighted citation impact, top 30% 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.

NCT04868773 phase1completednot on this map

A Phase 1 Study of the Combination of Cabozantinib With Trifluridine/Tipiracil (TAS-102) in Patients With Metastatic Colorectal Adenocarcinoma (mCRC)

TypeinterventionalSponsorUniversity of California, IrvineRan2021 to 2024Enrolled15ConditionsColorectal Cancer, Colorectal Carcinoma, Metastatic Cancer, CRCArmsCabozantinib, TAS-102
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

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 1 institution in 1 country.

Farshid DayyaniDivision of Hematology/Oncology, Department of Medicine and Chao Family Comprehensive Cancer Center, University of California Irvine, Orange, CA. Electronic address: fdayyani@hs.uci.edu.
Jasmine BalangueDivision of Hematology/Oncology, Department of Medicine and Chao Family Comprehensive Cancer Center, University of California Irvine, Orange, CA.
Jennifer ValerinDivision of Hematology/Oncology, Department of Medicine and Chao Family Comprehensive Cancer Center, University of California Irvine, Orange, CA.
Matthew J KeatingDivision of Hematology/Oncology, Department of Medicine and Chao Family Comprehensive Cancer Center, University of California Irvine, Orange, CA.
Jason A ZellDivision of Hematology/Oncology, Department of Medicine and Chao Family Comprehensive Cancer Center, University of California Irvine, Orange, CA.
Thomas H TaylorDepartment of Epidemiology & Biostatistics, Irvine, CA.
May T ChoDivision of Hematology/Oncology, Department of Medicine and Chao Family Comprehensive Cancer Center, University of California Irvine, Orange, CA.
University of California, Irvine · US

Funding

Univ.of Calif., Irvine Cancer Center Support GrantP30CA062203 · NCI · UNIVERSITY OF CALIFORNIA-IRVINE · PI Melanie Funes · 1994 to 2026
$57.9M
NCI NIH HHS P30 CA062203
6 · The paper itself

Abstract

introductionThis study determined the safety and recommended phase 2 dose (RP2D) of the multikinase inhibitor cabozantinib in combination with trifluridine/tipiracil (FTD/TPI) in refractory metastatic colorectal carcinoma (mCRC). PATIENTS AND

methodsSingle institution investigator-initiated phase 1 study using 3+3 design. Eligible mCRC patients had received prior standard regimens. Cabozantinib was given orally (p.o.) at 20 mg (dose level [DL] 0) or 40 mg (DL 1) daily on days 1-28, and FTD/TPI p.o. at 35 mg/m

resultsFifteen patients were enrolled. Median age 56 years (31-80), male (12/15), ECOG 0/1 = 9/6. Three patients were treated at DL 0 and another nine were treated at DL 1, none exhibiting a DLT. Most common any grade (G) treatment related adverse events (TRAE) were diarrhea (50%), nausea (42%), neutropenia (42%), fatigue (33%), and rash (25%). G3-4 TRAE were neutropenia (25%) and thrombocytopenia, hypokalemia, and weight loss (each 8%). No serious TRAE or G5 were reported. The RP2D was determined to be DL 1. Median PFS was 3.8 months (95% CI 1.9-6.8) and disease control rate was 86.7%.

conclusionThe combination of cabozantinib and FTD/TPI is feasible and tolerable at standard doses with the use of growth factors and showed encouraging clinical activity in refractory mCRC. CLINICALTRIALS: GOV: NCT04868773.

Indexed as

AdenocarcinomaAnilidesColorectal NeoplasmsFrontotemporal DementiaNeutropeniaPyridinesPyrrolidinesThymineAntineoplastic Combined Chemotherapy ProtocolsDrug CombinationsHumansMaleMiddle AgedTrifluridineUracilAnilidescabozantinibDrug CombinationsPyridinesPyrrolidinesThyminetipiracilTrifluridineUracilAngiogenesisAxlcMETRecommended phase II doseResistance

Identifiers

PMID38103947
PMCPMC11265208
OpenAlexW4389060601

What OpenQuestion holds

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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.