Evidence map›Paper›PMID 30418178›Full record

ArticleAmerican journal of clinical oncology2019

A Phase Ib Study of the FGFR/VEGFR Inhibitor Dovitinib With Gemcitabine and Capecitabine in Advanced Solid Tumor and Pancreatic Cancer Patients.

Wen Wee Ma, Hao Xie, Gerald Fetterly, Laura Pitzonka, Amy Whitworth, Charles LeVea, John Wilton, Krystin Mantione, Sarah Schihl, Grace K Dy and 6 more

Open access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in American journal of clinical oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 22% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. New Therapeutic Targets in RAS Wild-type Pancreatic Cancer.Current treatment options in oncology · 2024
    Review
  5. Article
  6. Single-Cell Analysis of Rohon-Beard Neurons Implicates Fgf Signaling in Axon Maintenance and Cell Survival.The Journal of neuroscience : the official journal of the Society for Neuroscience · 2024
    Article
  7. Review
  8. Fibroblast growth factor receptor 1 inhibition suppresses pancreatic cancer chemoresistance and chemotherapy-driven aggressiveness.Drug resistance updates : reviews and commentaries in antimicrobial and anticancer chemotherapy · 2024
    Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Article
  14. Molecular Characterization of KRAS Wild-type Tumors in Patients with Pancreatic Adenocarcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
    Article
  15. Article
  16. Review
  17. Review
  18. Article
  19. Article
  20. 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

16 authors at 4 institutions in 1 country.

Wen Wee MaDepartment of Oncology, Mayo Clinic, Rochester, MN.
Hao XieDepartment of Oncology, Mayo Clinic, Rochester, MN.
Gerald FetterlyAthenex Inc.
Laura PitzonkaAthenex Inc.
Amy WhitworthDepartments of Medicine.
Charles LeVeaPathology.
John WiltonDepartment of Pharmacology and Therapeutics, Bioanalytics, Metabolomics and Pharmacokinetics (BMPK) Shared Resource, Roswell Park Comprehensive Cancer Center.
Krystin MantioneDepartment of Pharmacology and Therapeutics, Bioanalytics, Metabolomics and Pharmacokinetics (BMPK) Shared Resource, Roswell Park Comprehensive Cancer Center.
Sarah SchihlDepartment of Pharmacology and Therapeutics, Bioanalytics, Metabolomics and Pharmacokinetics (BMPK) Shared Resource, Roswell Park Comprehensive Cancer Center.
Grace K DyDepartments of Medicine.
Patrick BolandDepartments of Medicine.
Renuka IyerDepartments of Medicine.
Wei TanBiostatistics, Roswell Park Comprehensive Cancer Center.
William BradyBiostatistics, Roswell Park Comprehensive Cancer Center.
Robert M StraubingerDepartment of Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences, State University of New York at Buffalo, Buffalo, NY.
Alex A AdjeiDepartment of Oncology, Mayo Clinic, Rochester, MN.
Roswell Park Comprehensive Cancer Center · USMayo Clinic in Arizona · USAthenex (United States) · USUniversity at Buffalo, State University of New York · US

Funding

Two-Spirit Films in Indigenous Cancer HealthP30CA016056 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI MARK G FRATTINI · 1985 to 2026
$116.6M
Tumor priming sequences combined with novel nanoparticle drug carriers for enhanced therapeutic efficacy in pancreatic cancer: a tripartite USA/Northern Ireland/Republic of Ireland consortiumR01CA198096 · NCI · STATE UNIVERSITY OF NEW YORK AT BUFFALO · PI CLYNES, MARTIN, MA, WEN WEE · 2015 to 2019
$2.2M
Pancreas cancer combination therapy based on stromal modulators and nano-carriersR21CA168454 · NCI · STATE UNIVERSITY OF NEW YORK AT BUFFALO · PI MA, WEN WEE, STRAUBINGER, ROBERT M · 2012 to 2013
$396k
NCI NIH HHS P30 CA016056NCI NIH HHS R01 CA198096NCI NIH HHS R21 CA168454
6 · The paper itself

Abstract

objectivesPreclinical studies demonstrated antitumor activity of dovitinib in pancreatic cancer models. This phase Ib study aimed to determine the maximum tolerated dose (MTD) of dovitinib in combination with gemcitabine and capecitabine and to characterize the safety and pharmacokinetic profile in patients with advanced pancreatic and biliary tract cancers and solid malignancies. MATERIALS AND

methodsPatients received gemcitabine 1000 mg/m² intravenously on days 1 and 8, capecitabine 1300 mg/m² oral daily from day 1 to 14, and dovitinib oral daily 5 days on and 2 days off, every 21-day cycle. The standard 3+3 dose escalation design was utilized and the study expanded to treat an additional 20 advanced pancreatic and biliary tract cancers patients at MTD.

resultsA total of 29 patients were enrolled. One patient experienced dose-limiting grade 3 colitis. Two patients developed clinically significant neuropathy after the first cycle requiring dose reduction. The MTD was not reached and dovitinib 300 mg was declared the recommended dose for expansion. The most frequent grade 2 or worse adverse events were fatigue (45%), neutropenia (41%), thrombocytopenia (34%), anemia (24%), nausea (24%), and palmer-plantar erythrodysaesthesia syndrome (21%). Partial responses were observed in 5 patients. Pharmacokinetic studies showed no drug-drug interaction between dovitinib, capecitabine and gemcitabine. Fibroblast growth factor 23 plasma level increased in 4 of 5 patients during the first cycle of treatment.

conclusionsDovitinib 300 mg daily is the recommended dose when combined with gemcitabine and capecitabine, achieving clinically relevant plasma concentrations. The study combination demonstrated encouraging efficacy signals in advanced pancreatic cancer.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesCapecitabineDeoxycytidineFemaleFollow-Up StudiesGemcitabineHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasmsPancreatic Neoplasms4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-oneBenzimidazolesCapecitabineDeoxycytidineFGFR1 protein, humanGemcitabineQuinolonesReceptor, Fibroblast Growth Factor, Type 1Receptors, Vascular Endothelial Growth Factor

Identifiers

PMID30418178
PMCPMC6345595
OpenAlexW2899622246

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.