Viewing Study NCT00087867



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Last Modification Date: 2024-10-26 @ 9:10 AM
Study NCT ID: NCT00087867
Status: COMPLETED
Last Update Posted: 2010-10-18
First Post: 2004-07-14

Brief Title: Study of Oral SCIO-469 in Relapsed Refractory Patients With Multiple Myeloma
Sponsor: Scios Inc
Organization: Scios Inc

Study Overview

Official Title: An Open-label Study of the Efficacy Safety and Tolerability of Oral SCIO-469 in Treatment of Relapsed Refractory Patients With Multiple Myeloma
Status: COMPLETED
Status Verified Date: 2010-10
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: The main objective of this study is to assess the efficacy of SCIOS-469 as monotherapy in relapsed refractory patients with multiple myeloma MM based on response rates
Detailed Description: The main objective of this study is to assess the efficacy of SCIO-469 as monotherapy in relapsed refractory patients with multiple myeloma MM based on response rates Patients took SCIO-469 two capsules 60 mg by mouth three times a day with water preferably with a meal for 72 days except on Days 1 and 30 of monotherapy and Days 1 and 11 of combination therapy On these days the second dose of SCIO-469 was administered after collection of the 12-hour PK sample and the third dose was not administered

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
Secondary IDs
Secondary ID Type Domain Link
SCIO-469MMY2001 B003 None None None