Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095628
Status:
COMPLETED
Last Update Posted:
2017-03-06
First Post:
2004-11-05
Brief Title:
SB-715992 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study of SB-715992 in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2017-01
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 phase II trial is studying how well SB-715992 works in treating patients with recurrent or metastatic head and neck cancer Drugs used in chemotherapy such as SB-715992 work in different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I To determine the antitumor activity of SB-715992 in recurrent andor metastatic squamous cell carcinoma of the head and neck using objective response rates partial and complete responses
SECONDARY OBJECTIVES
I To determine the duration of objective response rate and duration of stable disease progression-free median and overall survival rates of SB-715992 in recurrent andor metastatic squamous cell carcinoma of the head and neck
II To document the safety and tolerability of SB-715992 in recurrent andor metastatic squamous cell carcinoma of the head and neck
III 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
OUTLINE This is an open-label nonrandomized multicenter study
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
Patients are followed for survival
I To determine the antitumor activity of SB-715992 in recurrent andor metastatic squamous cell carcinoma of the head and neck using objective response rates partial and complete responses
SECONDARY OBJECTIVES
I To determine the duration of objective response rate and duration of stable disease progression-free median and overall survival rates of SB-715992 in recurrent andor metastatic squamous cell carcinoma of the head and neck
II To document the safety and tolerability of SB-715992 in recurrent andor metastatic squamous cell carcinoma of the head and neck
III 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
OUTLINE This is an open-label nonrandomized multicenter study
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
Patients are 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01CM62203 | NIH | None | httpsreporternihgovquickSearchN01CM62203 |
| PHL-031 | None | None | None |
| 6803 | None | None | None |