Evidence map›Paper›PMID 30393825›Full record

Trial reportInvestigational new drugs2019

Pazopanib with low fat meal (PALM) in advanced renal cell carcinoma.

Melissa A Reimers, Maryann M Shango, Stephanie Daignault-Newton, Rachel Dedinsky, Danielle Karsies, Shawna Kraft, Liam Riddle, Jeremy A Felton, Bo Wen, Christina Gersch and 3 more

Registry-linked trialAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02729194 (Pilot Study of Pazopanib With Low Fat Meal), 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.

NCT02729194 early_phase1completednot on this map

Pilot Study of Pazopanib With Low Fat Meal (PALM) in Advanced Renal Cell Carcinoma

TypeinterventionalSponsorUniversity of Michigan Rogel Cancer CenterRan2016 to 2017Enrolled16ConditionsCarcinoma, Renal CellArmsPazopanib, Low Fat Diet
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

13 authors.

Melissa A ReimersDepartment of Internal Medicine, Division of Hematology/Oncology, University of Michigan, Ann Arbor, MI, USA. mreimers@med.umich.edu.ORCID 0000-0002-5167-3630
Maryann M ShangoSwedish Medical Center, Swedish Cancer Institute, Seattle, WA, USA.
Stephanie Daignault-NewtonDepartment of Biostatistics, University of Michigan, Ann Arbor, MI, USA.
Rachel DedinskyCollege of Literature, Arts and Sciences, University of Michigan, Ann Arbor, MI, USA.
Danielle KarsiesRogel Cancer Center, University of Michigan Health System, Ann Arbor, MI, USA.
Shawna KraftCollege of Pharmacy, University of Michigan, Ann Arbor, MI, USA.
Liam RiddleUniversity of Michigan Medical School, University of Michigan, Ann Arbor, MI, USA.
Jeremy A FeltonCollege of Pharmacy, University of Michigan, Ann Arbor, MI, USA.
Bo WenCollege of Pharmacy, University of Michigan, Ann Arbor, MI, USA.
Christina GerschDepartment of Internal Medicine, Division of Hematology/Oncology, University of Michigan, Ann Arbor, MI, USA.
James M RaeDepartment of Internal Medicine, Division of Hematology/Oncology, Department of Pharmacology, University of Michigan, Ann Arbor, MI, USA.
Bruce G RedmanDepartment of Internal Medicine, Division of Hematology/Oncology, Ann Arbor, MI, USA.
Ajjai S AlvaDepartment of Internal Medicine, Division of Hematology/Oncology, Ann Arbor, MI, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background Pazopanib is approved for metastatic renal cell carcinoma (RCC). We assessed the safety and efficacy of pazopanib with a low fat meal (LFM): <400 cal and < 20% fat or 10 g per meal. Methods A single arm study of pazopanib with a LFM in 16 adult patients with metastatic RCC with a clear cell component, RECIST 1.1 measurable disease, ECOG PS ≤ 2, and ≤ 3 prior therapies. Pazopanib at 400 mg daily given with LFM for 12 weeks. Incremental dose increases up to 800 mg, or irreversible decreases to 200 mg, allowed every 2 weeks. Primary study endpoint was safety; adverse events (AE) measured per CTCAE version 4.0. Secondary endpoints of RECIST 1.1 response with assessment as 12 weeks; pharmacokinetic (PK) analysis at nine time points, and CYP3A4 polymorphism evaluation. Results Pazopanib with a LFM was well tolerated; 13 of 16 subjects completed all 12 weeks. Three patients withdrew due to adverse events (AEs), with five occurrences of grade 3 AEs. Conclusions Pazopanib with a LFM has acceptable safety and comparable efficacy to fasting administration. Total median pazopanib dose per subject for the study duration was 63.5% of maximum possible conventional dose. A larger study is warranted. Clinical Trial Registration Number: NCT02729194.

Indexed as

AgedAngiogenesis InhibitorsCarcinoma, Renal CellCombined Modality TherapyDiet, Fat-RestrictedFemaleFollow-Up StudiesHumansIndazolesKidney NeoplasmsMaleMiddle AgedPrognosisPyrimidinesSulfonamidesAngiogenesis InhibitorsIndazolespazopanibPyrimidinesSulfonamidesAdvanced diseaseFat mealPazopanibRenal cell carcinomaTyrosine kinase inhibitor therapy

Identifiers

PMID30393825

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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.