Phase I/II clinical trial

Phase 1

• Conditions: Malignant pleural mesothelioma

• Registration Number: JPRN-jRCT2080222946
• Lead Sponsor: Kyorin Pharmaceutical Co.,LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Histologic diagnosis of malignant pleural mesothelioma
-Patients must have measurable lesions, which are diagnosed.
-Patients refractory to the chemotherapy including pemetrexed or Patients who cannot undergo chemotherapy, Patients who refuse the systemic chemotherapy for malignant pleural mesothelioma.
-ECOG Performance status score: 0 - 2
-Prior radiotherapy must be completed at least 4 weeks before study enrollment, and the patients must have recovered from the toxic effects of the treatment prior to case entry.
-If chemotherapy was performed before study enrollment, prior chemotherapy must be completed at least 4 weeks and the patients must have recovered from the toxic effects of the treatment prior to case entry.
-Patients who have adequate main organs function
- Patients expected to be alive for at least 12 weeks before study enrollment
, etc.

Exclusion Criteria

-Patients with recurrent malignant pleural mesothelioma after surgical therapy or Patients with pneumonectomy due to the disease other than malignant pleural mesothelioma
-Patients with simultaneous tumor and/or metachronaus tumor (excluding patients with them whose disease-free interval is over 2 years)
-Patients with brain metastasis
-Patients who have received prior any gene therapies and immunotherapies
, etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified