Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102726
Status:
COMPLETED
Last Update Posted:
2017-03-23
First Post:
2005-02-01
Brief Title:
SB-497115 Oral Thrombopoietin Receptor Agonist Versus Placebo In Adult Cancer Patients Receiving Chemotherapy
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Double-Blind Randomized Multicenter Placebo-Controlled Parallel Group Dose Ranging Study to Assess the Efficacy Safety and Pharmacokinetics of an Oral Thrombopoietin Receptor AgonistSB497115-GR Administered at 50 75 and 100 mg to Cancer Patients Receiving Multiple Cycles of Chemotherapy
Status:
COMPLETED
Status Verified Date:
2017-03
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:
SB497115 is an oral agent which activates the thrombopoietin receptor and increases platelet counts in healthy volunteers This study is examining several different doses of SB497115 versus placebo as treatment for patients with advanced solid tumors scheduled to receive chemotherapy with carboplatin and paclitaxel every 21 days Patients will receive SB497115 on days 2-11 of each 21 day cycle for at least 2 cycles of chemotherapy and for a maximum of 8 cycles of chemotherapy
Detailed Description:
A Double-Blind Randomized Multicenter Placebo-Controlled Parallel Group Dose Ranging Study to Assess the Efficacy Safety and Pharmacokinetics of an Oral Thrombopoietin Receptor Agonist SB-497115-GR Administered at 50 75 and 100 mg to Cancer Patients Receiving Multiple Cycles of Chemotherapy
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