Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-04-15 @ 2:52 PM
Study NCT ID:
NCT01699061
Status:
COMPLETED
Last Update Posted:
2019-02-12
First Post:
2012-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Tivantinib on the QTC Interval in Cancer Subjects
Sponsor:
Daiichi Sankyo
Organization:
Study Overview
Official Title:
A PHASE 1 SINGLE-BLIND, SINGLE-SEQUENCE STUDY ASSESSING THE EFFECT OF TIVANTINIB ON THE QTC INTERVAL IN CANCER SUBJECTS
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: