Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113438
Status:
COMPLETED
Last Update Posted:
2011-11-01
First Post:
2005-06-07
Brief Title:
Safety and Effectiveness of Combretastatin A-4 Phosphate Combined With Chemotherapy in Advanced Solid Tumors
Sponsor:
Mateon Therapeutics
Organization:
Mateon Therapeutics
Study Overview
Official Title:
A Randomized Open-Labeled Phase II Study of Combretastatin A-4 Phosphate in Combination With Paclitaxel and Carboplatin to Evaluate the Safety and Efficacy in Subjects With Advanced Imageable Malignancies
Status:
COMPLETED
Status Verified Date:
2011-10
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:
This is a study evaluating the safety and effectiveness of Combretastatin A4 Phosphate CA4P combined with the chemotherapy drugs carboplatin and paclitaxel The full treatment and observation time should be about 5 months During this time the patient should receive 18 CA4P infusions and 6 carboplatin followed by paclitaxel treatments Patients will be randomized into one of two CA4P dose-level groups in order to recommend a preferred dose-level for future studies At least 2 dynamic contrast enhanced-magnetic resonance imaging DCE-MRI scans will be conducted to monitor the blood flow through the tumor before and after treatment with CA4P
Detailed Description:
This is a phase II study evaluating the safety and efficacy of Combretastatin A4 Phosphate CA4P combined with carboplatin and paclitaxel Treatment is for a maximum of 6 consecutive 21-day cycles Patients are randomized onto one of two CA4P dosing arms 45 or 63 mgm2 CA4P is administered on days 1 8 and 15 of each cycle Carboplatin and paclitaxel AUC 6 and 200 mgm2 respectively are administered on day 2 of each cycle At least 2 DCE-MRI scans will be performed to evaluate the change in tumor blood flow following treatment with CA4P
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 |
|---|---|---|---|
| HCI-13214 | OTHER | Huntsman Cancer Institute | None |