Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103311
Status:
COMPLETED
Last Update Posted:
2015-03-02
First Post:
2005-02-07
Brief Title:
SB-715992 in Treating Patients With Advanced or Metastatic Colorectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Non-Comparative Study of SB-715992 Given Weekly or Every Three Weeks in Advanced or Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2013-10
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 randomized phase II trial is studying how well SB-715992 works in treating patients with advanced or metastatic colorectal cancer Drugs used in chemotherapy such as SB-715992 work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
Detailed Description:
PRIMARY OBJECTIVES
I To determine the objective response rate in patients with advanced or metastatic colorectal cancer treated with SB-715992 once a week for 3 weeks every 28 days and SB-715992 once every 21 days
SECONDARY OBJECTIVES
I To determine the time to tumor progression progression free and overall survival of patients and toxicity in patients with advanced or metastatic colorectal cancer treated with SB-715992 once a week for 3 weeks every 28 days and SB-715992 once every 21 days
II To characterize the population pharmacokinetic PK parameters of SB-715992 including an assessment of significant covariates on SB-715992 PK and an assessment of the potential relationships between the pharmacokinetics of SB-715992 and relevant safety and efficacy endpoints
IV To examine cytoskeletal morphology changes in response to SB-715992 in peripheral blood mononuclear cells and tumors by fluorescent immunohistochemistry
V To evaluate mRNA expression of betaΙΙΙ-tubulin and KSP in archival tumor tissue
VI To determine the frequency of genomic polymorphisms in genes targeted by SB-715992 measured in peripheral blood mononuclear cells and to assess whether germline polymorphisms DNA of genes targeted by SB-715992 KSP inhibitor are associated with toxicity and clinical outcome in patients with colorectal cancer Further whether genes involved with the metabolism CYP3A4 and resistance MDR1 affect the outcome in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive SB-715992 IV over 1 hour on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
ARM II Patients receive SB-715992 IV over 1 hour on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter
I To determine the objective response rate in patients with advanced or metastatic colorectal cancer treated with SB-715992 once a week for 3 weeks every 28 days and SB-715992 once every 21 days
SECONDARY OBJECTIVES
I To determine the time to tumor progression progression free and overall survival of patients and toxicity in patients with advanced or metastatic colorectal cancer treated with SB-715992 once a week for 3 weeks every 28 days and SB-715992 once every 21 days
II To characterize the population pharmacokinetic PK parameters of SB-715992 including an assessment of significant covariates on SB-715992 PK and an assessment of the potential relationships between the pharmacokinetics of SB-715992 and relevant safety and efficacy endpoints
IV To examine cytoskeletal morphology changes in response to SB-715992 in peripheral blood mononuclear cells and tumors by fluorescent immunohistochemistry
V To evaluate mRNA expression of betaΙΙΙ-tubulin and KSP in archival tumor tissue
VI To determine the frequency of genomic polymorphisms in genes targeted by SB-715992 measured in peripheral blood mononuclear cells and to assess whether germline polymorphisms DNA of genes targeted by SB-715992 KSP inhibitor are associated with toxicity and clinical outcome in patients with colorectal cancer Further whether genes involved with the metabolism CYP3A4 and resistance MDR1 affect the outcome in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive SB-715992 IV over 1 hour on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
ARM II Patients receive SB-715992 IV over 1 hour on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter
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 |
|---|---|---|---|
| 6800 | OTHER | CTEP | None |
| NCI-2012-02834 | REGISTRY | None | None |
| PHII-51 | OTHER | None | None |