JPRN-UMIN000008093CompletedPhase 1
Phase 1 Clinical Trial of intra-thoracic administration of Zoredronic Acid in Subjects with Unresectable Malignant Pleural Mesothelioma - Phase 1 Trial of Zoredronic Acid in Malignant Pleural Mesothelioma
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Chiba University Hospital
- Enrollment
- 18
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to 80years-old (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Patient with active multiple primary cancer (synchronous multiple primary cancer and invasive cancer of other organs) Patient with symptomatic brain metastasis requiring any treatments Patient underwent thoracic irradiation therapy or pleurodesis (within a month). Patient with interstitial pneumonia, confirmed by clinical examination or by chest CT scan Patients with history of myocardial infarction (MI) in recent 6 month, or those with any risk of MI recurrence. Patient with other severe medical complications. Patient with history of drug-related allergy to zoredronic acid or other bisphosphonate or those with AEs over Grade 3 in CTCAE. Patient with stomatognathic disease (pulpitis, gingivitis,etc) requiring invasive (surgical) treatment. Patient who received chemotherapy for mesothelioma, or those participated other clinical trial for unapproved drug with in a month. Difficult to participate in the trial because of psychiatric disorder or psychiatric symptoms Pregnant or lactating woman. Ineligible to the trial based on decision of an investigator, such as poor compliance to follow up in the clinical course.
Investigators
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