Evidence map›Paper›PMID 19228751›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2009

Population pharmacokinetics of romidepsin in patients with cutaneous T-cell lymphoma and relapsed peripheral T-cell lymphoma.

Sukyung Woo, Erin R Gardner, Xiaohong Chen, Sandra B Ockers, Caitlin E Baum, Tristan M Sissung, Douglas K Price, Robin Frye, Richard L Piekarz, Susan E Bates and 1 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00007345 (Phase II Trial of Depsipeptide in Patients With Cutaneous T-Cell Lymphoma and Relapsed Peripheral T-Cell Lymphoma), which is not on this map. Cited by 31 papers.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed
3.2field-weighted citation impact, top 8% 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.

NCT00007345 phase2completednot on this map

Phase II Trial of Depsipeptide in Patients With Cutaneous T-Cell Lymphoma and Relapsed Peripheral T-Cell Lymphoma

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2001 to 2015Enrolled131ConditionsCutaneous T Cell Lymphoma, Peripheral T Cell LymphomaArmsRomidepsin
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 75 citations in OpenAlex.

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  7. Phase II multi-institutional trial of the histone deacetylase inhibitor romidepsin as monotherapy for patients with cutaneous T-cell lymphoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2009
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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

11 authors at 2 institutions in 1 country.

Sukyung WooClinical Pharmacology Program, Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland 20892, USA.
Erin R Gardner
Xiaohong Chen
Sandra B Ockers
Caitlin E Baum
Tristan M Sissung
Douglas K Price
Robin Frye
Richard L Piekarz
Susan E Bates
William D Figg
Center for Cancer Research · USNational Cancer Institute · US

Funding

Translational Studies of the Histone Deacetylase Inhibitor RomidepsinZIABC010621 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI BATES, SUSAN · 2009 to 2015
$6.2M
Pharmacokinetic and Pharmacodynamic Modeling of Anticancer AgentsZICBC010548 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2009 to 2018
$5.9M
Translational Studies of the Histone Deacetylase Inhibitor RomidepsinZ01BC010621 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI BATES, SUSAN · 2004 to 2008
$1.7M
Pharmacokinetic and Pharmacodynamic Modeling of Anticancer AgentsZ01BC010548 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2003 to 2008
$815k
Intramural NIH HHS NIH0011335962Intramural NIH HHS Z01 BC010548Intramural NIH HHS Z01 BC010621NCI NIH HHS N01 CO012400NCI NIH HHS N01-CO-12400
6 · The paper itself

Abstract

purposeRomidepsin is a potent histone deacetylase inhibitor under clinical development. The objective of this study was to evaluate the effect of demographic, clinical, and pharmacogenetic covariates on the pharmacokinetics of romidepsin in patients with T-cell lymphoma. EXPERIMENTAL

designPharmacokinetic assessment was done in 98 patients enrolled in a phase II study who received 14 or 18 mg/m2 of romidepsin as a 4-hour infusion on day 1 during their first treatment cycle. Population modeling was done using a nonlinear mixed effects modeling approach to explore the effects of polymorphic variations in CYP3A4, CYP3A5, SLCO1B3, and ABCB1, all of which encode genes thought to be involved in romidepsin disposition.

resultsA two-compartment model with linear kinetics adequately described the romidepsin disposition. Population clearance was 15.9 L/h with between-patient variability of 37%. ABCB1 2677G>T/A variant alleles tended toward a reduced clearance and lower volume of tissue distribution, but this was not supported by a statistical significance. Genetic variations in CYP3A4/5 and SCLO1B3 had no effect on the systemic exposure.

conclusionThe population pharmacokinetic analysis indicates moderate interindividual variability in romidepsin pharmacokinetics and no clinically relevant covariates associated with the unexplained pharmacokinetic variability of romidepsin in this population.

Indexed as

AdultAgedAntibiotics, AntineoplasticATP Binding Cassette Transporter, Subfamily BATP Binding Cassette Transporter, Subfamily B, Member 1DepsipeptidesFemaleGenotypeHumansLymphoma, T-Cell, CutaneousLymphoma, T-Cell, PeripheralMaleMiddle AgedModels, BiologicalSkin NeoplasmsABCB1 protein, humanAntibiotics, AntineoplasticATP Binding Cassette Transporter, Subfamily BATP Binding Cassette Transporter, Subfamily B, Member 1Depsipeptidesromidepsin

Identifiers

PMID19228751
PMCPMC2707030
OpenAlexW2132343700

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.