Evidence map›Paper›PMID 33866531›Full record

ArticleDrugs in R&D2021

Clinical Pharmacokinetics of Oral Sodium Selenite and Dosing Implications in the Treatment of Patients with Metastatic Cancer.

Priya Jayachandran, Susan J Knox, Maria Garcia-Cremades, Radojka M Savić

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Drugs in R&D, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02184533 (A Phase I Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Palliative Radiation Therapy in Patients With Metastatic Cancer), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 25% 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.

NCT02184533 phase1completednot on this map

A Phase I Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Palliative Radiation Therapy in Patients With Metastatic Cancer

TypeinterventionalSponsorStanford UniversityRan2014 to 2018Enrolled15ConditionsAdenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate CancerArmssodium selenite, radiation therapy, laboratory biomarker analysis, pharmacological study, questionnaire administration
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Article
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

4 authors at 2 institutions in 1 country.

Priya JayachandranDepartment of Bioengineering and Therapeutic Sciences, School of Pharmacy, University of California, San Francisco, 1700 4th Street, Room 501, San Francisco, CA, 94158, USA. priya.jayachandran.pharmd.mse@gmail.com.ORCID http://orcid.org/0000-0002-4197-4085
Susan J KnoxDepartment of Radiation Oncology, Stanford University School of Medicine, Stanford, CA, USA.
Maria Garcia-CremadesDepartment of Bioengineering and Therapeutic Sciences, School of Pharmacy, University of California, San Francisco, 1700 4th Street, Room 501, San Francisco, CA, 94158, USA.
Radojka M SavićDepartment of Bioengineering and Therapeutic Sciences, School of Pharmacy, University of California, San Francisco, 1700 4th Street, Room 501, San Francisco, CA, 94158, USA.
University of California, San Francisco · USStanford University · US

Funding

Stanford Center for Clinical & Translational Education and Research (Spectrum)UL1TR003142 · NCATS · STANFORD UNIVERSITY · PI O'HARA, RUTH M · 2019 to 2023
$45.0M
Spectrum Stanford Center for clinical and Translational Research and EducationUL1TR001085 · NCATS · STANFORD UNIVERSITY · PI CULLEN, MARK RICHARD, GREENBERG, HARRY BERNARD · 2013 to 2017
$37.1M
NCATS NIH HHS UL1 TR001085NCATS NIH HHS UL1 TR003142
6 · The paper itself

Abstract

backgroundSelenite is a radiosensitizer and inhibitor of androgen receptor expression and function. In a phase I study (NCT02184533) in 15 subjects with metastatic cancer receiving daily oral sodium selenite with palliative radiation therapy, disease stabilization was observed, as evidenced by tumor regression, marked reduction in pain symptoms, and decreased prostate-specific antigen levels (only patients with castrate-resistant prostate cancer).

objectiveThe aim of this work was to characterize the pharmacokinetics of selenite to suggest dosing strategies and to propose a study design for further investigation.

methodsWith selenium plasma concentrations obtained from five dosing cohorts (5.5, 11, 16.5, 33, and 49.5 mg), a population pharmacokinetic model was constructed using NONMEM. The model described externally administered selenite (inorganic) with a baseline component for endogenous selenium levels. Using the pharmacokinetic model, simulations were performed to suggest dosing regimens that achieved in vitro target selenite levels, and optimal pharmacokinetic sampling times for a subsequent study were proposed using PopED.

resultsA one-compartment model characterized selenite pharmacokinetics. Parameter estimates were absorption rate constant (0.64 h DISCUSSION: The population model described the pharmacokinetic data well. Three regimens (33 mg daily, 11 mg BID, 5.5 mg TID) achieved in vitro target selenite levels after one dose. The model and optimal sampling times may inform future studies evaluating the efficacy of selenite for metastatic cancer treatment.

Indexed as

NeoplasmsSodium SeleniteAdministration, OralBiological AvailabilityHumansMaleSelenious AcidSelenious AcidSodium Selenite

Identifiers

PMID33866531
PMCPMC8206290
OpenAlexW3156556177

What OpenQuestion holds

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LicenceCC BY-NC
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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.