TumorsPhase 1NCT02271516
to evaluate188Re-BMEDA-liposome in Patient With Primary Solid Tumor in Advanced or Metastatic Stage
A Phase 1 study testing 188Re-BMEDA-liposome in people with Tumors, run by National Atomic Research Institute, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Tumors
- What is being tested?
- 188Re-BMEDA-liposome
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2014to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read the detailed description
Rhenium-188 is an ideal radionuclide for therapeutic use due to its maximum beta emission of 2.12MeV, short physical half-life of 16.9 hours, and its 155-keV gamma emission for imaging purposes. 188Re-BMEDA-liposome consists of 2 separate components (Rhenium-188 and liposome) and BMEDA as a linker. This study aims to find the MTD, evaluate the safety, efficacy profiles and investigate the biodistribution, radioactivity and radiation dosimetry of 188Re-BMEDA-liposome on primary solid tumor in metastatic stage patient by a single intravenous injection course.
- Conditions
- Tumors
- Being tested
- 188Re-BMEDA-liposome
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
188Re-BMEDA-liposomeRadiation
EKG at baseline and in 24hours after administration
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: 188Re-BMEDA-liposome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 30 days per cohort
Secondary outcomes (5)
change in vital signs and pysical examination
assess the safety issue from the change in vital signs (BP, PR, RR and temperature) and physical examinations
Measured: from day 0 to up t0 60 days per cohort
change in lab data
assess the safety issue from the change in lab data including heatology lab data change, Biochemistry laboratory data change and urinalysis data change
Measured: from day 0 to up t0 60 days per cohort
Adverse event(s)
assessed by NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v4.03
Measured: from day 0 to up t0 60 days per cohort
Serious Adverse event(s)
All AE(s) and SAE(s) which occurred within follow-up visit after the single dose administration of study drug should be followed until resolution or the event is considered stable.
Measured: from day 0 to up t0 60 days per cohort
Change in EKG
Patient will be examined the EKG by standard 12-lead at screen visit for eligibility. After enrollment, patient will be attached on a 24h-portable EKG monitor to monitoring EKG before and post-administration of Stage I and II low dose and therapeutic infusion dose for 24hrs
Measured: in 24hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Some concerns arose for the accumulation of radioactivity in liver and spleen.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Atomic Research Institute, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shyh-Jen Wang, MD, Principal investigator, Taipei Veterans General Hospital (Taiwain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271516
- Sponsor's protocol ID
- QCR12009
- Status last verified
- Jul 2020
- First submitted
- 15 Oct 2014
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02271516
- Acronym / sponsor ID
- QCR12009
- Conditions
- Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Some concerns arose for the accumulation of radioactivity in liver and spleen.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- National Atomic Research Institute, TaiwanUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rhenium-188 is an ideal radionuclide for therapeutic use due to its maximum beta emission of 2.12MeV, short physical half-life of 16.9 hours, and its 155-keV gamma emission for imaging purposes. 188Re-BMEDA-liposome consists of 2 separate components (Rhenium-188 and liposome) and BMEDA as a linker. This study aims to find the MTD, evaluate the safety, efficacy profiles and investigate the biodistribution, radioactivity and radiation dosimetry of 188Re-BMEDA-liposome on primary solid tumor in metastatic stage patient by a single intravenous injection course.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 188Re-BMEDA-liposome | Experimental | Radiation: 188Re-BMEDA-liposomeStage 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- brain metastases
- serious concurrent infection or nonmalignant illness that is uncontrolled
- uncontrolled intercurrent illness
- Immunocompromised
- significant traumatic injury within 3 weeks before Day 0
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 188Re-BMEDA-liposomeEKG at baseline and in 24hours after administration | Radiation | 188Re-BMEDA-liposome |
Primary outcome
Determine the MTD
Time frame: up to 30 days per cohort
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).
5 secondary outcomes
change in vital signs and pysical examination
Time frame: from day 0 to up t0 60 days per cohort
change in lab data
Time frame: from day 0 to up t0 60 days per cohort
Adverse event(s)
Time frame: from day 0 to up t0 60 days per cohort
Serious Adverse event(s)
Time frame: from day 0 to up t0 60 days per cohort
Change in EKG
Time frame: in 24hrs
Results and safety
The study was stopped early (reason given: Some concerns arose for the accumulation of radioactivity in liver and spleen.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shyh-Jen Wang, MD principal investigator
Taipei Veterans General Hospital (Taiwain)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 188Re-BMEDA-liposome in people with Tumors, run by National Atomic Research Institute, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Some concerns arose for the accumulation of radioactivity in liver and spleen.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the MTD (time frame: up to 30 days per cohort). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.