NCT04887961

Reprab Study: PLD + Trabectedin Rechallenge

Rechallenge With PLD Added to Trabectedine in Recurrent Ovarian Cancer: a Multicenter Prospective Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RECHALLENGE WITH PEGYLATED LIPOSOMAL DOXORUBICIN ADDED TO TRABECTEDIN IN RECURRENT OVARIAN CANCER: A MULTICENTER, PROSPECTIVE TRIAL

Detailed description

To demonstrate that rechallenge with pegylated liposomal doxorubicin (PLD) with the combination of trabectedin (Yondelis®) is active (objective response rate) in relapsed ovarian cancer patients who have already received pegylated liposomal doxorubicin and progress within 6-12 months after the end of last platinum or in fully platinum sensitive patients not able to receive or not willing to receive other platinum treatments

Conditions

• Relapsed Ovarian Cancer

Interventions

Type	Name	Description
DRUG	PLD and Trabectedin rechallenge	Platinum partially sensitive patients i.e. patients who recur with a platinum free interval between 6 and 12 months, who have previously received pegylated liposomal doxorubicin and are suitable for rechallenge with pegylated liposomal doxorubicin (PLD) with the combination of trabectedin (Yondelis®) and relapsed ovarian cancer fully platinum sensitive patients not able to receive or not willing to receive other platinum treatments

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2021-05-14
• Last updated: 2021-08-09

Locations

1 site across 1 country: Italy