NCT04421547

Efficacy of Letrozole in Recurrent Ovarian Cancer

Phase III Randomized Control Case Study of Letrozole in Women With Heavily Pretreated Ovarian Cancer (MITO32)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized phase III multicenter study investigating the role of letrozole in heavily pretreated recurrent ovarian cancer.

Detailed description

This is a randomized, open-label, phase III, multicenter, global study evaluating the efficacy and safety of Letrozole in heavily pretreated recurrent ovarian cancer patients in comparison to physician' choice chemotherapy. Subjects who meet all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to one of the two arms, as follow: Arm A: Letrozole 1 tablet (2,5 mg) orally once a day in 28-day cycles Arm B: Pegylated Liposomal Doxorubicin 40 mg/m2 d1q28 or Topotecan 4 mg/m2 d1,8,15q28 or Gemcitabine 1000 mg/m2 d1,8,15q28 or Paclitaxel 80 mg/m2 d1,8,15q28 In case of objective response and acceptable toxicity, no maximum number of cycles of treatment is defined. The aim of the study is to assess the activity of Letrozole in women with recurrent epithelial ovarian cancer, heavily pretreated.

Conditions

• Epithelial Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Letrozole 2.5mg	This study will investigate the role of Letrozole in patients affected by heavily pretreated platinum resistant ovarian cancer, compared to standard treatment.
DRUG	Standard single agent chemotherapy	Either Paclitaxel 80 mg/m2 as a 1-h infusion, on days 1,8,15,22 every 28 days or Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 given every 4 weeks or Topotecan 4mg/m2 IV on days 1,8,15 every 4 weeks or Gemcitabine 1000 mg/m2 IV over 30 min on days 1,8,15 every 28 days.

Timeline

• Start date: 2020-06-22
• Primary completion: 2024-11-01
• Completion: 2024-11-04
• First posted: 2020-06-09
• Last updated: 2025-03-07

Locations

1 site across 1 country: Italy