to evaluate188Re-BMEDA-liposome in Patient With Primary Solid Tumor in Advanced or Metastatic Stage
NCT ID: NCT02271516
Last Updated: 2020-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
3 participants
INTERVENTIONAL
2014-10-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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188Re-BMEDA-liposome
Stage I:
188Re-BMEDA-liposomes, 14±1.4 mCi, single dose
Stage II:
188Re-BMEDA-liposomes, dose-escalation, single dose Dose Level Dose of 188Re-BMEDA-liposome (mCi/kg)
1. 0.42±0.04 mCi/kg
2. 0.63±0.06 mCi/kg
3. 0.84±0.08 mCi/kg
4. 1.05±0.11 mCi/kg
5. 1.26±0.13 mCi/kg
6. 1.47±0.15 mCi/kg
188Re-BMEDA-liposome
EKG at baseline and in 24hours after administration
Interventions
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188Re-BMEDA-liposome
EKG at baseline and in 24hours after administration
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
80 Years
ALL
No
Sponsors
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National Atomic Research Institute, Taiwan
OTHER
Responsible Party
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Principal Investigators
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Shyh-Jen Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Taipei Veterans General Hospital (Taiwain)
Locations
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Taipei Veterans General Hospital (Taiwain)
Taipei, , Taiwan
Countries
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Other Identifiers
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QCR12009
Identifier Type: -
Identifier Source: org_study_id
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