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Clinical Trials/JPRN-UMIN000008093
JPRN-UMIN000008093
Completed
Phase 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

Chiba University Hospital0 sites18 target enrollmentJune 4, 2012

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Malignant Pleural Mesothelioma
Sponsor
Chiba University Hospital
Enrollment
18
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 4, 2012
End Date
December 24, 2018
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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