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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02271516 |
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Date of registration:
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15/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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to evaluate188Re-BMEDA-liposome in Patient With Primary Solid Tumor in Advanced or Metastatic Stage
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Scientific title:
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A Phase I, Open-label, Dose-escalation Study to Determine the Maximum Tolerance Dose (MTD) and to Evaluate the Safety of 188Re-BMEDA-liposome in Patient With Primary Solid Tumor in Advanced or Metastatic Stage. |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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3 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02271516 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Shyh-Jen Wang, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Taipei Veterans General Hospital (Taiwain) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient with histologically confirmed diagnosis of primary solid tumor, and with
pathologically or radiologically documented metastases
- Disease that is measurable or evaluable by RECIST 1.1 criteria (for Solid Tumors)
- Patient with metastatic cancer that are refractory to current standard/available
therapies
Exclusion Criteria:
- brain metastases
- serious concurrent infection or nonmalignant illness that is uncontrolled
- uncontrolled intercurrent illness
- Immunocompromised
- significant traumatic injury within 3 weeks before Day 0
- History of hypersensitivity to any component of study drug
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Tumors
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Intervention(s)
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Radiation: 188Re-BMEDA-liposome
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Primary Outcome(s)
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Determine the MTD
[Time Frame: up to 30 days per cohort]
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Secondary Outcome(s)
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Change in EKG
[Time Frame: in 24hrs]
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Adverse event(s)
[Time Frame: from day 0 to up t0 60 days per cohort]
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change in lab data
[Time Frame: from day 0 to up t0 60 days per cohort]
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Serious Adverse event(s)
[Time Frame: from day 0 to up t0 60 days per cohort]
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change in vital signs and pysical examination
[Time Frame: from day 0 to up t0 60 days per cohort]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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