Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-27 @ 10:41 PM
Study NCT ID:
NCT02312661
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2014-11-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Metformin With Carboplatin/Paclitaxel Chemotherapy in Patients With Advanced Ovarian Cancer
Sponsor:
University Medical Center Groningen
Organization:
Study Overview
Official Title:
Phase Ib Study of Metformin in Combination With Carboplatin/Paclitaxel Chemotherapy in Patients With Advanced Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2024-05
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:
OVMET
Brief Summary:
Molecularly targeted agents which inhibit the mammalian target of rapamycin (mTOR) pathway and/or circumvent p53 in the induction of apoptosis are exciting potential targets in ovarian cancer. Metformin is a biguanide, widely used in the treatment of type 2 diabetes mellitus, that has shown anti-cancer activity in preclinical studies. The main mechanism of metformin's effect is mTOR pathway inhibition and, in addition, it has been shown to circumvent p53-induced apoptosis making it an exciting, potentially effective drug in ovarian cancer.
Detailed Description:
A phase Ib, single-centre, dose-escalation trial with a traditional escalation rule with fixed dose levels ("3 + 3" rule). The recommended phase II dose will be defined as the maximum predefined dose level at which 0 of 3 or ≤ 1 of 6 subjects experience a drug-related dose limiting toxicity (DLT) during cycle 1 and 2 of treatment. An estimated 10-20 patients will be required for this study.
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?: