Clinical Trials Directory

Trials / Terminated

TerminatedNCT01127178

Study of Poly (ADP-Ribose) Polymerase (PARP) Inhibitor E7016 in Combination With Temozolomide in Subjects With Advanced Solid Tumors

Phase 1 Study of the Poly (ADP-Ribose) Polymerase Inhibitor E7016 in Combination With Temozolomide in Subjects With Advanced Solid Tumors

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
12 (actual)
Sponsor
Eisai Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) of poly (ADP-Ribose) polymerase inhibitor E7016 when used with temozolomide (TMZ) in patients with advanced solid tumors and gliomas.

Conditions

Interventions

TypeNameDescription
DRUGE7016 + TMZSingle-Dose PK Period (single oral dose of E7016 on Day -7) in the Dose-Escalation Component; Multiple-Dose Treatment Cycles (7 days of oral E7016 + 5 days of oral TMZ) added in Cycle 1 of the Dose-Escalation Component and in Cycles 1 through 6 of the Expansion Component.

Timeline

Start date
2010-03-29
Primary completion
2011-02-24
Completion
2011-02-24
First posted
2010-05-20
Last updated
2024-10-10
Results posted
2024-10-10

Locations

5 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01127178. Inclusion in this directory is not an endorsement.