Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT00410358
Status:
COMPLETED
Last Update Posted:
2020-12-19
First Post:
2006-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Dose Escalation of Gimatecan Administered Orally to Japanese Patients With Advanced Solid Tumor.
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor.
Status:
COMPLETED
Status Verified Date:
2012-10
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:
This study assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients. Gimatecan is administered orally for five consecutive days, every 28 days, to adult patients with advanced solid tumors who have progressed despite standard therapy or for whom standard systemic therapy does not exist.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: