NCT02312661

Study of Metformin With Carboplatin/Paclitaxel Chemotherapy in Patients With Advanced Ovarian Cancer

Phase Ib Study of Metformin in Combination With Carboplatin/Paclitaxel Chemotherapy in Patients With Advanced Ovarian Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epithelial Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Metformin	Metformin in increasing doses will be added to carboplatin/paclitaxel chemotherapy
DRUG	Carboplatin	Intravenous carboplatin chemotherapy in three-weekly cycles, for a maximum of 6 cycles
DRUG	Paclitaxel	Intravenous paclitaxel chemotherapy in three-weekly cycles, for a maximum of 6 cycles

Timeline

• Start date: 2015-10-05
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2014-12-09
• Last updated: 2024-05-06

Locations

1 site across 1 country: Netherlands