Evidence map›Paper›PMID 39809926›Full record

ArticleBJC reports2025

A phase I study of the CDK4/6 inhibitor ribociclib combined with gemcitabine in patients with advanced solid tumors.

Aurora Norman, Mahesh Seetharam, Jacob Allred, Jianping Kong, Mateusz Opyrchal, Wen Wee Ma, Yanyan Lou, Grace K Dy, Amit Mahipal, S John Weroha and 3 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BJC reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03237390 (Phase I Study of CDK4/6 Inhibitor Ribociclib), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT03237390 phase1completednot on this map

Phase I Study of CDK4/6 Inhibitor Ribociclib (LEE011) Combined With Gemcitabine in Patients With Advanced Solid Tumors

TypeinterventionalSponsorMayo ClinicRan2018 to 2022Enrolled43ConditionsAdvanced Malignant Solid Neoplasm, Metastatic Malignant Solid NeoplasmArmsGemcitabine Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study, Ribociclib
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Clinical application and drug resistance mechanism of gemcitabine.Frontiers in cell and developmental biology · 2025
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Aurora Norman *Mayo Clinic, Rochester, MN, USA.
Mahesh Seetharam *Mayo Clinic, Phoenix, AZ, USA.
Jacob AllredMayo Clinic, Rochester, MN, USA.
Jianping KongMayo Clinic, Rochester, MN, USA.
Mateusz OpyrchalIndiana University, Indianapolis, USA.
Wen Wee MaCleveland Clinic, Cleveland, OH, USA.
Yanyan LouMayo Clinic, Jacksonville, FL, USA.
Grace K DyRoswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
Amit MahipalUniversity Hospitals at Case Western University, Cleveland, OH, USA.
S John WerohaMayo Clinic, Rochester, MN, USA.
Andrea E Wahner HendricksonMayo Clinic, Rochester, MN, USA.
Joel M ReidMayo Clinic, Rochester, MN, USA.
Alex A AdjeiCleveland Clinic, Cleveland, OH, USA. adjeia2@CCF.org.

Funding

Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI AKHILESH PANDEY · 1985 to 2026
$151.3M
TRAINING GRANT IN CLINICAL PHARMACOLOGYT32GM008685 · NIGMS · MAYO CLINIC ROCHESTER · PI Liewei Wang · 1998 to 2026
$8.2M
NCI NIH HHS P30 CA015083NIGMS NIH HHS T32 GM008685NIGMS NIH HHS T32GM 08685
6 · The paper itself

Abstract

backgroundBased on preclinical data showing addition of CDK4/6 inhibitors to gemcitabine was synergistic, ribociclib was evaluated in combination with gemcitabine to determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT).

methodsIn this single arm multicohort phase I trial, we evaluated the safety and efficacy of ribociclib plus gemcitabine in patients with advanced solid tumors. Patients received gemcitabine intravenously on days 1 and 8 followed by ribociclib days 8-14, with treatment repeated every 3 weeks.

resultsThe study enrolled 43 patients between October 2017 and September 2019. The escalation phase (19 patients) determined the MTD and recommended phase II dose (RP2D) to be ribociclib 800 mg daily and gemcitabine 1000 mg/m2 for the expansion phase (24 patients). One patient experienced Grade 4 thrombocytopenia. Eleven patients experienced Grade 3 adverse events (AE), the most common being neutropenia, thrombocytopenia, and anemia. No partial or complete responses were observed. 15/22 (68%) of efficacy evaluable patients who received the MTD achieved best response of stable disease.

conclusionsThe addition of ribociclib to gemcitabine was tolerated well and yielded stability of tumors in both cohorts. Biomarkers such as Rb status and activity of CDK2 and CDK4/6 complexes may help to select patients who may respond better to the combination of gemcitabine and ribociclib. CLINICAL

trial registrationNCT03237390.

Identifiers

PMID39809926
PMCPMC11733298

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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.