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NCT02150733 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetics of Tivantinib in Subjects With Advanced Solid Tumors and Hepatic Impairment

A Phase 1 study, sponsored by Daiichi Sankyo.

Completed
Registry status
Phase 1
Development phase
29
Enrollment target

NCT02150733: Completed Phase 1 study, sponsored by Daiichi Sankyo.

NCT02150733 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02150733, a Phase 1 study, has completed, sponsored by Daiichi Sankyo.

COMPLETED
Registry status
Phase 1
Development phase
29 participants
Enrollment target

Study Summary

This is a multi-center, open-label, Phase 1 study to evaluate the impact of hepatic impairment on the pharmacokinetics of Tivantinib in cancer subjects with varying degrees of hepatic function, from normal to severely impaired.

Primary Outcome

The following pharmacokinetic parameters will be determined: population estimates of apparent total clearance (CL/F), apparent volume of distribution (V/F), area under the concentration-time curve during the dosing interval (AUCtau), and maximum concentration (Cmax) during the dosing interval.

Interventions

  • DRUG Tivantinib

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2014-04
Est. Completion 2016-07
Phase Phase 1
Daiichi Sankyo

236 total trials

What the finished NCT02150733 record still lists

NCT02150733 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).

The record links to 0 conditions, and to 1 intervention - of which Tivantinib is the first listed.

NCT02150733 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02150733 about?

NCT02150733 is a clinical study titled "Pharmacokinetics of Tivantinib in Subjects With Advanced Solid Tumors and Hepatic Impairment". This is a multi-center, open-label, Phase 1 study to evaluate the impact of hepatic impairment on the pharmacokinetics of Tivantinib in cancer subjects with varying degrees of hepatic function, from normal to severely impaired.

What is the current status of trial NCT02150733?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2014-04. Estimated completion is 2016-07.

What interventions are being tested in trial NCT02150733?

The interventions under investigation include: Tivantinib (DRUG).

Who is sponsoring clinical trial NCT02150733?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02150733's enrollment target sits among peer trials

29 1440th of 2000 higher than 554 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02150733, the US trial registry maintained by the National Library of Medicine. NCT02150733 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.