Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma.
- Sponsor
- Swiss Cancer Institute
- Study ID
- NCT03213301
- Phase
- PHASE2
- Status
- Completed
Conditions
- Malignant Pleural Mesothelioma, Advanced
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Lurbinectedin — DRUG3.2 mg/m2 i.v. every 3 weeks
Study Details
Aim of this study is to provide the "proof of concept" of efficacy and tolerability of lurbinectedin monotherapy in progressive malignant mesotheliomas.
Key Dates
- Start date
- Sep 28, 2017
- Status verified
- Jul 2021
- Primary completion
- Jun 11, 2021
- Completion
- Jun 11, 2021
Study Design
- Enrollment
- 42 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: LurbinectedinLurbinectedin 3.2 mg/m2 i.v. every 3 weeks (one cycle) until progression, unacceptable toxicity or patient's withdrawal.
Primary Outcome Measure
Progression free survival (PFS) at 12 weeks [ Time Frame: at 12 weeks ]
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