to evaluate188Re-BMEDA-liposome in Patient With Primary Solid Tumor in Advanced or Metastatic Stage

NCT02271516 | Terminated Phase 1

• 1 other identifier: QCR12009
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 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.

Conditions

Tumors

Outcome Measures

Primary Outcomes (1)

• Determine the MTD

  The design will use cohort of 3 patients. If none of the first 3 patients experience DLT, then dose escalation will proceed for the next dose level of patients unless the present dose level is level 6 (1.47±0.15 mCi/kg).

  up to 30 days per cohort

Secondary Outcomes (5)

• change in vital signs and pysical examination

  from day 0 to up t0 60 days per cohort

• change in lab data

  from day 0 to up t0 60 days per cohort

• Adverse event(s)

  from day 0 to up t0 60 days per cohort

• Serious Adverse event(s)

  from day 0 to up t0 60 days per cohort

• Change in EKG

  in 24hrs

Study Arms (1)

188Re-BMEDA-liposome

EXPERIMENTAL

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

Radiation: 188Re-BMEDA-liposome

Interventions

188Re-BMEDA-liposome RADIATION

EKG at baseline and in 24hours after administration

188Re-BMEDA-liposome

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Atomic Research Institute, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital (Taiwain)

Taipei, 11217, Taiwan

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Shyh-Jen Wang, MD

  Taipei Veterans General Hospital (Taiwain)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 22, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 30, 2020

Record last verified: 2020-07

Locations

TW (1)