Reprab Study: PLD + Trabectedin Rechallenge
Phase 2
- Conditions
- Relapsed Ovarian Cancer
- Interventions
- Drug: PLD and Trabectedin rechallenge
- Registration Number
- NCT04887961
- Brief 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 64
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm PLD and Trabectedin rechallenge PLD 30 mg/mq 1 h iv + Trabectedin 1.1 mg/mq 3 h iv d1q21 up to 6 cycles or PD.
- Primary Outcome Measures
Name Time Method Objective Response Rate 30 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fondazione Policlinico Gemelli IRCCS
🇮🇹Roma, Italy