PMID- 30393825
OWN - NLM
STAT- MEDLINE
DCOM- 20200205
LR  - 20220316
IS  - 1573-0646 (Electronic)
IS  - 0167-6997 (Linking)
VI  - 37
IP  - 2
DP  - 2019 Apr
TI  - Pazopanib with low fat meal (PALM) in advanced renal cell carcinoma.
PG  - 323-330
LID - 10.1007/s10637-018-0692-8 [doi]
AB  - 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.
FAU - Reimers, Melissa A
AU  - Reimers MA
AUID- ORCID: 0000-0002-5167-3630
AD  - Department of Internal Medicine, Division of Hematology/Oncology, University of 
      Michigan, Ann Arbor, MI, USA. mreimers@med.umich.edu.
FAU - Shango, Maryann M
AU  - Shango MM
AD  - Swedish Medical Center, Swedish Cancer Institute, Seattle, WA, USA.
FAU - Daignault-Newton, Stephanie
AU  - Daignault-Newton S
AD  - Department of Biostatistics, University of Michigan, Ann Arbor, MI, USA.
FAU - Dedinsky, Rachel
AU  - Dedinsky R
AD  - College of Literature, Arts and Sciences, University of Michigan, Ann Arbor, MI, 
      USA.
FAU - Karsies, Danielle
AU  - Karsies D
AD  - Rogel Cancer Center, University of Michigan Health System, Ann Arbor, MI, USA.
FAU - Kraft, Shawna
AU  - Kraft S
AD  - College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.
FAU - Riddle, Liam
AU  - Riddle L
AD  - University of Michigan Medical School, University of Michigan, Ann Arbor, MI, 
      USA.
FAU - Felton, Jeremy A
AU  - Felton JA
AD  - College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.
FAU - Wen, Bo
AU  - Wen B
AD  - College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.
FAU - Gersch, Christina
AU  - Gersch C
AD  - Department of Internal Medicine, Division of Hematology/Oncology, University of 
      Michigan, Ann Arbor, MI, USA.
FAU - Rae, James M
AU  - Rae JM
AD  - Department of Internal Medicine, Division of Hematology/Oncology, Department of 
      Pharmacology, University of Michigan, Ann Arbor, MI, USA.
FAU - Redman, Bruce G
AU  - Redman BG
AD  - Department of Internal Medicine, Division of Hematology/Oncology, Ann Arbor, MI, 
      USA.
FAU - Alva, Ajjai S
AU  - Alva AS
AD  - Department of Internal Medicine, Division of Hematology/Oncology, Ann Arbor, MI, 
      USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02729194
PT  - Clinical Trial
PT  - Journal Article
DEP - 20181105
PL  - United States
TA  - Invest New Drugs
JT  - Investigational new drugs
JID - 8309330
RN  - 0 (Angiogenesis Inhibitors)
RN  - 0 (Indazoles)
RN  - 0 (Pyrimidines)
RN  - 0 (Sulfonamides)
RN  - 7RN5DR86CK (pazopanib)
SB  - IM
MH  - Aged
MH  - Angiogenesis Inhibitors/*therapeutic use
MH  - Carcinoma, Renal Cell/pathology/*therapy
MH  - Combined Modality Therapy
MH  - Diet, Fat-Restricted/*methods
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Indazoles
MH  - Kidney Neoplasms/pathology/*therapy
MH  - Male
MH  - Middle Aged
MH  - Prognosis
MH  - Pyrimidines/*therapeutic use
MH  - Sulfonamides/*therapeutic use
OTO - NOTNLM
OT  - Advanced disease
OT  - Fat meal
OT  - Pazopanib
OT  - Renal cell carcinoma
OT  - Tyrosine kinase inhibitor therapy
EDAT- 2018/11/06 06:00
MHDA- 2020/02/06 06:00
CRDT- 2018/11/06 06:00
PHST- 2018/08/07 00:00 [received]
PHST- 2018/10/30 00:00 [accepted]
PHST- 2018/11/06 06:00 [pubmed]
PHST- 2020/02/06 06:00 [medline]
PHST- 2018/11/06 06:00 [entrez]
AID - 10.1007/s10637-018-0692-8 [pii]
AID - 10.1007/s10637-018-0692-8 [doi]
PST - ppublish
SO  - Invest New Drugs. 2019 Apr;37(2):323-330. doi: 10.1007/s10637-018-0692-8. Epub 
      2018 Nov 5.