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Zoledronic Acid in Advanced Malignant Mesothelioma
NCT01204203Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2009
- Primary completion
- Apr 2015
- Countries
- 1
- Sponsor
- University of Alabama at Birmingham
- Modality
- Small Molecules
- Drugs
- zoledronic acid
- Conditions
- malignant pleural mesothelioma (MPM)
01
Overview
Phase 2, open-label, single-arm trial of zoledronic acid in malignant pleural mesothelioma (MPM), sponsored by University of Alabama at Birmingham. Primary endpoint: Tumor Response Rate Following Zoledronic Acid at 28 months. Started Jun 2009; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Zometa
Zoledronic acid administered IV on Day 1 of a 21-day cycle at a concentration of 4 mg.
03
Who it enrols
Adults with unresectable malignant pleural mesothelioma, measurable disease, ECOG 0-2, adequate organ function, and life expectancy >= 2 months. Excludes patients with CNS tumors, other active malignancies, significant heart disease, HIV/hepatitis, or recent systemic anticancer therapy.
04
Endpoints
Primary
Tumor Response Rate Following Zoledronic Acid
Secondary
Progression Free Survival
Overall Survival
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