Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00447226
Status:
TERMINATED
Last Update Posted:
2012-06-12
First Post:
2007-03-13
Brief Title:
Randomized Discontinuation Study of Lapatinib Versus Placebo in Subjects With Documented Tumor Progression After Chemotherapy or Where no Approved Therapy Exists
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase II Placebo Controlled Double-Blind Randomized Discontinuation Study of Lapatinib Administered Orally to Subjects With ErbB2 Positive Ovarian GastricEsophageal Adenocarcinoma Uterine Serous Papillary or Bladder Cancer
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study had failed to meet the primary objective of tumor response rate at 12 weeks from first dose
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the efficacy and safety of lapatinib in patients with ErbB2 positive ovarian gastricesophageal adenocarcinoma uterine serous papillary or bladder cancers
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None