Newton Study (NEW Dosing mainTenance Therapy Ovarian caNcer)

Last updated on July 2021

Recruitment

Recruitment Status: Recruiting
Estimated Enrollment: Same as current

Summary

Conditions

Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Carcinoma

Type

Interventional

Phase

Phase 2

Design

Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a study built up by a randomized and a no-randomized part. Randomized part: Patients who either have a baseline body weight ?58 and <77kg, or have a baseline body weight ?77kg and baseline platelet count <150,000/µL (named as restricted population) will be randomly assigned to receive RADAR dosing or the SmPC dosing. Randomization ratio will be 1:1 and will be based on a minimization procedure accounting for the following factors: i. platinum sensitivity; ii. use of bevacizumab in conjunction with the penultimate platinum based therapy; iii. best response (complete or partial) during the last platinum regimen. No-randomized part: Patients with weight <58 or ?77kg and baseline platelet count ?150,000/µL will be enrolled into the study but not randomized.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age: Between 18 years and 125 years
Gender: Only males

Description

Not Provided

Tracking Information

NCT #: NCT03891576
Collaborators: North Eastern German Society of Gynaecological Oncology
Investigators: Principal Investigator: Nicoletta Colombo, MD Istituto Europeo di Oncologia (IEO) - Milan