Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465491
Status:
UNKNOWN
Last Update Posted:
2009-04-14
First Post:
2007-04-23
Brief Title:
Study of Picoplatin Efficacy After Relapse
Sponsor:
Poniard Pharmaceuticals
Organization:
Poniard Pharmaceuticals
Study Overview
Official Title:
A Randomized Controlled Phase III Trial of Picoplatin and BSC Versus BSC Alone in Patients With Small Cell Lung Cancer SCLC Refractory or Progressive Within Six Months of Completing First-Line Platinum-Containing Chemotherapy
Status:
UNKNOWN
Status Verified Date:
2009-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
SPEAR
Brief Summary:
Picoplatin is a new type of platinum drug that has been investigated in several clinical trials and may provide an improved safety profile over current treatment options This study is designed to compare the efficacy and safety of picoplatin plus Best Supportive Care BSC with BSC alone Best Supportive Care includes care and treatment to optimize the comfort of patients and their ability to function as well as to minimize the side-effects of anti-cancer treatments
Detailed Description:
This Phase 3 study will enroll subjects with Small Cell Lung Cancer SCLC who are refractory or progressive within 6 months of completing first-line platinum-containing chemotherapy Subjects will be centrally randomized 21 to receive picoplatin plus BSC every 3 weeks or BSC alone After discontinuation of picoplatin all subjects will continue to receive BSC and will continue to be evaluated every 3 weeks until discontinuation from the study death or the end of the study After discontinuation of picoplatin subjects may be treated with another chemotherapy at their physicians discretion and then will be followed for survival
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