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

Sponsor
AstraZeneca
Study ID
NCT02923947
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumours

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib; AZD9291 — DRUG
    80mg tablet dose to be taken orally - single dose in part A, daily dosing in Part B and continued access until progression or no longer receiving benefit

Study Details

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

Key Dates

Start date
May 4, 2017
Status verified
Nov 2022
Primary completion
Sep 20, 2018
Completion
Oct 28, 2022

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Normal renal function
    For inclusion in the study as a patient with normal renal function, patients must have creatinine clearance ≥90 mL/min.
  • Experimental: Severe renal impairment
    For inclusion in the study as a patient with severe renal impairment, patients must have stable severe renal impairment (creatinine clearance \<30 mL/min), as defined by the Cockcroft Gault equation, for at least 2 months prior to Day 1.

Primary Outcome Measure

Area under the plasma concentration-time curve from zero to infinity for osimertinib [ Time Frame: On Day of dosing in Part A - predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, 120, 168, 216hrs post-dose ]

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