Trial Profile
A Phase 1, Open-Label, Single-Dose Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib
Status:
Discontinued
Phase of Trial:
Phase I
Latest Information Update: 05 Apr 2021
Price :
$35
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At a glance
- Drugs Erdafitinib (Primary)
- Indications Bladder cancer; Breast cancer; Cholangiocarcinoma; Gastric cancer; Liver cancer; Lymphoma; Multiple myeloma; Non-small cell lung cancer; Oesophageal cancer; Prostate cancer; Solid tumours; Urogenital cancer
- Focus Pharmacokinetics
- Sponsors Janssen Research & Development
- 26 Mar 2021 Status changed from recruiting to discontinued due to mild/moderate hepatic impairment (HI) cohorts completed with no impact to erdafitinib exposure.Severe HI cohort enrollment stopped early.
- 09 Nov 2020 Planned primary completion date changed from 23 Sep 2020 to 23 Jun 2021.
- 10 Sep 2020 Planned End Date changed from 21 Dec 2020 to 23 Jun 2021.