Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087477
Status:
TERMINATED
Last Update Posted:
2005-08-30
First Post:
2004-07-08
Brief Title:
A Pilot Study of Pivanex in Patients With Malignant Melanoma
Sponsor:
Titan Pharmaceuticals
Organization:
Titan Pharmaceuticals
Study Overview
Official Title:
A Pilot Study of Pivanex a Histone Deacetylase Inhibitor in Patients With Malignant Melanoma
Status:
TERMINATED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot study will assess the safety and efficacy of Pivanex alone in patients with malignant melanoma who have relapsed after treatment with chemotherapy or Interleukin-2 IL-2 Pivanex is an investigational agent
Detailed Description:
Rationale Pivanex is a histone deacetylase inhibitor that induces tumor differentiation inhibits proliferation and induces apoptosis Pivanex has been generally well tolerated in clinical trials and has shown preliminary evidence of efficacy in patients with non-small cell lung cancer Pivanex has shown in-vitro and in-vivo evidence of anti-tumor activity against melanoma and therefore represents a promising therapeutic approach to patients with malignant melanoma
Purpose This open-label trial will determine the response rate of Pivanex in patients with malignant melanoma
Objectives
Determine time to disease progression
Determine overall survival
Determine the safety profile of Pivanex in malignant melanoma
Outline This is an open-label single center study in patients with malignant melanoma whose disease has progressed or failed to respond to chemotherapy or Interleukin-2 IL-2 Patients will be treated with 25 gm2 of Pivanex administered intravenously over 6 hours daily on Days 1 - 3
Treatment will be repeated every 21 days until tumor progression or the patient is withdrawn from treatment for other protocol-specified reasons Tumor status will be assessed prior to every odd-numbered treatment cycle using the Response Evaluation Criteria in Solid Tumors RECIST method Patients who continue to experience tumor response or stabilization at the time treatment is discontinued will be followed every 12 weeks for tumor status until disease progression
Purpose This open-label trial will determine the response rate of Pivanex in patients with malignant melanoma
Objectives
Determine time to disease progression
Determine overall survival
Determine the safety profile of Pivanex in malignant melanoma
Outline This is an open-label single center study in patients with malignant melanoma whose disease has progressed or failed to respond to chemotherapy or Interleukin-2 IL-2 Patients will be treated with 25 gm2 of Pivanex administered intravenously over 6 hours daily on Days 1 - 3
Treatment will be repeated every 21 days until tumor progression or the patient is withdrawn from treatment for other protocol-specified reasons Tumor status will be assessed prior to every odd-numbered treatment cycle using the Response Evaluation Criteria in Solid Tumors RECIST method Patients who continue to experience tumor response or stabilization at the time treatment is discontinued will be followed every 12 weeks for tumor status until disease progression
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