Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113334
Status:
COMPLETED
Last Update Posted:
2014-08-07
First Post:
2005-06-07
Brief Title:
Study of ABT-510 Thrombospondin Analogue in Patients With Advanced Head and Neck Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase 1b2 Study of ABT-510 Thrombospondin Analogue in Patients With Advanced Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2014-07
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 goals of this clinical research study are to see how individuals with advanced head and neck cancer respond to treatment with the new drug thrombospondin ABT-510 and to learn how effective it is in destroying cancer cells The safety of ABT-510 and the effect ABT-510 has on cells in the body will also be studied
Detailed Description:
This is a phase IbII single-center open-label study designed to assess the safety tolerability pharmacokinetics and biologic efficacy of ABT-510 thrombospondin Participants will be patients with incurable head and neck cancer
Patients will begin at a fixed dose level of thrombospondin subcutaneously twice daily Cycles of treatment are 28 days 4 weeks Patients will be treated with thrombospondin until progression of tumor or toxicity
Patients will begin at a fixed dose level of thrombospondin subcutaneously twice daily Cycles of treatment are 28 days 4 weeks Patients will be treated with thrombospondin until progression of tumor or toxicity
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