Trials / Completed
CompletedNCT01699061
Effect of Tivantinib on the QTC Interval in Cancer Subjects
A PHASE 1 SINGLE-BLIND, SINGLE-SEQUENCE STUDY ASSESSING THE EFFECT OF TIVANTINIB ON THE QTC INTERVAL IN CANCER SUBJECTS
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Daiichi Sankyo · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the effects of tivantinib on the QTc interval in patients with solid tumors
Detailed description
The study is designed to estimate the maximum change in QTcF (change from baseline) between placebo and multiple-dose tivantinib. A tivantinib oral dose of 360 mg BID has been selected for this study because this is the highest dose currently being evaluated in clinical studies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tivantinib | 3 tivantinib tablets 120 mg administered twice daily with a meal starting on Day 2 |
| DRUG | Placebo | Placebo tablet administered with a meal twice a day on Day 1 |
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2013-01-01
- Completion
- 2013-05-01
- First posted
- 2012-10-03
- Last updated
- 2019-02-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01699061. Inclusion in this directory is not an endorsement.