Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00383851
Status:
UNKNOWN
Last Update Posted:
2007-12-06
First Post:
2006-10-02
Brief Title:
Randomized Trial of ATN-224 and Temozolomide in Advanced Melanoma
Sponsor:
Attenuon
Organization:
Attenuon
Study Overview
Official Title:
A Randomized Phase II Trial of ATN-224 in Combination With Temozolomide or Temozolomide Followed by ATN-224 in Patients With Advanced Melanoma
Status:
UNKNOWN
Status Verified Date:
2007-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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 is a multicenter randomized phase II study to evaluate the safety and efficacy of oral ATN-224 plus temozolomide in patients with advanced melanoma Patients will be randomized 11 between temozolomide and ATN-224 and temozolomide followed by ATN-224 Patients assigned to the sequential treatment group will receive temozolomide until progression of disease is documented and then receive ATN-224 as a single agent until documentation of progression of disease using the last tumor assessment on temozolomide therapy as the baseline assessment
Detailed Description:
According to the National Cancer Institute PDQ database advanced melanoma is refractory to most standard systemic therapy and all newly diagnosed patients should be considered candidates for clinical trials Although advanced melanoma is relatively resistant to therapy several biologic response modifiers and cytotoxic agents have been reported to produce objective responses Once melanoma is metastatic treatments are palliative rather than curative In spite of many attempts at multimodality therapy the prognosis in this disease remains poor Further agents are needed if progress is to be made with melanoma treatment
ATN-224 is an orally active small molecule that has been shown in cellular and animal models to be antiangiogenic and to have activity against melanoma cell lines Clinical studies with a similar agent ammonium tetrathiomolybdate indicate that the agent can be administered continuously on a daily basis for years in some patients ATN-224 has the potential to affect the progression of melanoma by mechanisms that include both antiangiogenic and antitumor pathways Temozolomide a commonly used agent for melanoma also has a tolerable profile
ATN-224 is an orally active small molecule that has been shown in cellular and animal models to be antiangiogenic and to have activity against melanoma cell lines Clinical studies with a similar agent ammonium tetrathiomolybdate indicate that the agent can be administered continuously on a daily basis for years in some patients ATN-224 has the potential to affect the progression of melanoma by mechanisms that include both antiangiogenic and antitumor pathways Temozolomide a commonly used agent for melanoma also has a tolerable profile
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