Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000763
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposis Sarcoma
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposis Sarcoma
Status:
COMPLETED
Status Verified Date:
2021-10
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:
To assess toxicity and determine the MTD of intravenous TNP-470 administered weekly in patients with AIDS-related Kaposis sarcoma To assess pharmacokinetics and tumor response of the drug
Since evidence shows that neovascularization is important in the development of Kaposis sarcoma drugs that inhibit angiogenesis such as TNP-470 may be of benefit in patients with the disease
Since evidence shows that neovascularization is important in the development of Kaposis sarcoma drugs that inhibit angiogenesis such as TNP-470 may be of benefit in patients with the disease
Detailed Description:
Since evidence shows that neovascularization is important in the development of Kaposis sarcoma drugs that inhibit angiogenesis such as TNP-470 may be of benefit in patients with the disease
Patients are entered at 7 escalating dose levels of TNP-470 PER AMENDMENT 9396 dose maximum level changed Four patients treated at a given dose level must receive at least 4 weeks of therapy before escalation in subsequent cohorts proceeds If 50 percent of patients at a given dose level experience dose-limiting toxicity the previous dose is defined as the MTD and an additional two patients are treated at the MTD Patients receive treatment for 12 weeks followed by 2 weeks of rest followed by an additional 12 weeks of treatment Patients are followed for 12 weeks post-treatment
Patients are entered at 7 escalating dose levels of TNP-470 PER AMENDMENT 9396 dose maximum level changed Four patients treated at a given dose level must receive at least 4 weeks of therapy before escalation in subsequent cohorts proceeds If 50 percent of patients at a given dose level experience dose-limiting toxicity the previous dose is defined as the MTD and an additional two patients are treated at the MTD Patients receive treatment for 12 weeks followed by 2 weeks of rest followed by an additional 12 weeks of treatment Patients are followed for 12 weeks post-treatment
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11192 | REGISTRY | DAIDS ES Registry Number | None |