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A Phase I, Open-Label Study to Determine the Effect of Repeat Dosing of Trametinib on the Pharmacokinetics and Safety of a Combined Oral Contraceptive (Norethindrone Plus Ethinyl Estradiol) and to Characterize the Pharmacokinetics of Trametinib's Metabolite M5 in Female Subjects With Solid Tumors

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A Phase I, Open-Label Study to Determine the Effect of Repeat Dosing of Trametinib on the Pharmacokinetics and Safety of a Combined Oral Contraceptive (Norethindrone Plus Ethinyl Estradiol) and to Characterize the Pharmacokinetics of Trametinib's Metabolite M5 in Female Subjects With Solid Tumors

Status: Withdrawn prior to enrolment
Phase of Trial: Phase I

Latest Information Update: 22 Jun 2023

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At a glance

  • Drugs Trametinib (Primary) ; Ethinylestradiol/norethisterone
  • Indications Solid tumours
  • Focus Pharmacokinetics
  • Sponsors GlaxoSmithKline; GSK

    • Most Recent Events

    • 25 Jan 2016 Status changed from not yet recruiting to withdrawn prior to enrolment, as reported by ClinicalTrials.gov.
    • 11 Sep 2015 Planned initiation date changed from 1 Sep 2015 to 1 Feb 2016 as per ClinicalTrials.gov record.
    • 26 Mar 2015 Planned initiation date changed from 1 Jun 2015 to 1 Sep 2015 as reported by ClinicalTrials.gov.

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