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NCT02923947

Study to Assess Osimertinib in Patients w/ Adv Solid Tumours & Normal Kidney Function or Severe Kidney Impairment

Completed Phase 1 Last updated 27 November 2023
What this trial tests

Phase 1 trial testing Osimertinib; AZD9291 in Solid Tumours in 16 participants. Completed in 28 October 2022.

Timeline
4 May 2017
Primary endpoint
20 September 2018
28 October 2022

Quick facts

Lead sponsorAstraZeneca
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment16
Start date4 May 2017
Primary completion20 September 2018
Estimated completion28 October 2022
Sites11 locations across France, Spain, South Korea

Drugs / interventions tested

Conditions studied

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 130, any sex, with Solid Tumours. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to assess the effect of severe renal impairment on the levels of AZD9291 in the blood in patients with advanced solid tumours compared to patients with normal renal function

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A multicenter, phase I, pharmacokinetic study of osimertinib in cancer patients with normal renal function or severe renal impairment.
    Vishwanathan K, Sanchez-Simon I, Keam B, Penel N, et al · · 2020 · cited 9× · PMID 32567817 · DOI 10.1002/prp2.613

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Other recruiting trials for Solid Tumours

Currently open trials in the same condition.

Other AstraZeneca trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02923947.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing