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NCT01443481 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics (PK) of TKI258 in Cancer Patients With Normal and Impaired Hepatic Function
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT01443481 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 38 participants.
The verdict
NCT01443481, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
This is a multi-center, open label study to assess pharmacokinetics (PK) of TKI258 at single-dose and steady state in adult cancer patients either with mild, moderate or severe hepatic impairment or with normal hepatic function. Hepatic function in study patients will be categorized as normal, mild, moderate or severe based upon pre-dose (Day 1) total bilirubin and AST/ALT levels. Starting dose of TKI258 will depend on total bilirubin and ALT/AST levels at baseline. Patients will be treated until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other reason.
Interventions
- DRUG Dovitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2011-11 |
| Est. Completion | 2014-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01443481
The ClinicalTrials.gov registry entry for NCT01443481 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Dovitinib is the first listed.
NCT01443481 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01443481 about?
NCT01443481 is a clinical study titled "Pharmacokinetics (PK) of TKI258 in Cancer Patients With Normal and Impaired Hepatic Function". This is a multi-center, open label study to assess pharmacokinetics (PK) of TKI258 at single-dose and steady state in adult cancer patients either with mild, moderate or severe hepatic impairment or with normal hepatic function. Hepatic function in study patients will be categorized as normal, mild,...
What is the current status of trial NCT01443481?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2011-11. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01443481?
The interventions under investigation include: Dovitinib (DRUG).
Who is sponsoring clinical trial NCT01443481?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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