Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086216
Status:
COMPLETED
Last Update Posted:
2007-12-21
First Post:
2004-06-28
Brief Title:
Safety and Efficacy of Atiprimod for Patients With Refractory Multiple Myeloma
Sponsor:
Callisto Pharmaceuticals
Organization:
Callisto Pharmaceuticals
Study Overview
Official Title:
An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Refractory or Relapsed Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2007-12
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 is a Phase IIIa clinical trial to identify the maximum tolerated dose of atiprimod and to evaluate the safety of atiprimod in patients with refractory or relapsed multiple myeloma
Detailed Description:
This is a multi-center open-label dose escalation study intended to identify the MTD of atiprimod alone and the MTD of atiprimod when given in combination with ursodiol The atiprimod dose will be escalated in sequential cohorts Ten dose levels of atiprimod are planned for the atiprimod alone dose escalation 30 60 90 120 180 240 300 360 420 and 480 mgday to be given orally Six dose levels of atiprimod are planned for the atiprimod in combination with ursodiol dose escalation 180 240 300 360 420 and 480 mgday to be given orally The dose of ursodiol will remain constant for all cohorts 300 mg ursodiol orally three times a day everyday Up to 105 patients will participate depending on the level at which toxicity is observed Patients will be assigned to dose level in the order of study entry
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 |
|---|---|---|---|
| efficacy | None | None | None |
| pharmacokinetics | None | None | None |
| research markers | None | None | None |