CompletedPhase 1

Hepatic Impairment Study For Crizotinib In Advanced Cancer Patients

United States88 participantsStarted 2012-07

Plain-language summary

This study is designed to evaluate the potential effect of hepatic impairment on the pharmacokinetics and safety of crizotinib in advanced cancer patients. Advanced cancer patients with mild, moderate or severe liver dysfunction as well as patients with normal liver function will be enrolled in this study.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. The presence of at least one lesion, measuring ≥ 2 cm, with characteristic arterial enhancement and venous washout in the setting of liver cirrhosis and/or hepatitis B or C infection.
✓. The presence of liver lesion(s) (as defined in a.) with AFP ≥ 400 ng/mL.
✓. Tissue confirmation.

What they're measuring

Area Under Plasma Concentration Time Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib: Cycle 2 Day 1

Timeframe: Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose

Maximum Observed Plasma Concentration (Cmax) of Crizotinib: Cycle 2 Day 1

Timeframe: Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose

Trial details

NCT IDNCT01576406

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-06

Results submitted2017-05-16

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