Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-25 @ 3:58 PM
Study NCT ID:
NCT01256268
Status:
COMPLETED
Last Update Posted:
2017-08-30
First Post:
2010-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Carboplatin/Taxol/Ridaforolimus in Endometrial, Ovarian and Solids
Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Organization:
Study Overview
Official Title:
Phase 1A/B Study of Combination Carboplatin, Paclitaxel and Ridaforolimus in Patients With Solid, Endometrial, and Ovarian Cancers
Status:
COMPLETED
Status Verified Date:
2017-08
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:
The purpose of this study is to:
* Test the safety of a new investigational drug called MK-8669 (ridaforolimus)
* Determine the maximum tolerated dose of MK-8669
* Determine the effectiveness of the maximum tolerated dose of MK-8669
* Test the safety of a new investigational drug called MK-8669 (ridaforolimus)
* Determine the maximum tolerated dose of MK-8669
* Determine the effectiveness of the maximum tolerated dose of MK-8669
Detailed Description:
This is a phase 1A/1B study. Phase 1A is designed to determine the maximal tolerated dose (MTD) and toxicity of ridaforolimus in combination with paclitaxel and carboplatin in patients with advanced or recurrent solid tumors. The MTD determined in this study will be the recommended dose to study in the phase 1B or in future phase 2 trials.
Study Oversight
Has Oversight DMC:
True
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?: