Metastatic CancerPhase 1/2NCT03058809
Evaluation of Viatar™ Oncopheresis System in Removing CTC From Whole Blood
A Phase 1/2 study testing Oncopheresis in people with Metastatic Cancer, run by Viatar LLC.
Trial summary
This study will access the safety and efficacy of the Viatar™ Oncopheresis System to remove a meaningful quantity of circulating tumor cells from the blood of subjects' with breast, colon or prostate solid tumor cancers in a single treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- Oncopheresis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to May 2019
- Phase
- Phase 1/2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of breast, colon or prostate cancer
- No prior cancer therapy or failed first line therapy
- >= 25 CTC per 7.5 mL of blood within 1 week prior to oncopheresis treatment
- > 1 month life expectancy
- Adequate baseline hematological function as assessed by the following laboratory values:
- Hemoglobin > 9 g/dl
Show all 9Show fewer
- Platelets > 100,000/mm3
- WBC > 3,000/mm3
- Absolute Neutrophil Count > 1,500/mm3
Who cannot join
- Coagulation disorders and/or a history of thromboembolic complications, including known hypersensitivity to citrate: e.g., abnormal platelet count, prothrombin time and partial activated thromboplastin time and with a history of deep vein thrombus or pulmonary embolism
- Patients with known immunodeficiency virus (HIV)
Trial locations and contacts
No sites are listed yet.
Steve Keaney contact
About this study
Official title: Evaluation of the Saftey and Efficacy of the Viatar™ Oncopheresis System in Removing Circulating Tumor Cells From Whole Blood
This study will access the safety and efficacy of the Viatar™ Oncopheresis System to remove a meaningful quantity of circulating tumor cells from the blood of subjects' with breast, colon or prostate solid tumor cancers in a single treatment. CTC reduction will be measured as the change in circulating tumor cells as determined before and after treatment.
- Conditions
- Metastatic Cancer
- Being tested
- Oncopheresis
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OncopheresisDevice
Oncopheresis is a type of apheresis incorporating an extracorporeal blood circuit and a filter to separate circulating tumor cells from normal blood components.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Breast, Colon and Prostate Cancer | Experimental | Metastatic breast, colon or prostate cancer patients will have their CTC levels determined on 3 days before treatment with the Viatar Oncopheresis System to establish a baseline value, a pretreatment value, a post treatment value and on 4 additional instances over a period of 7 days post treatment to establish a CTC rebound profile using a validated CTC enumeration system. Receives: Device: Oncopheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Circulating Tumor Cells
% change in enumerated circulating tumor cells after treatment with Viatar Oncopheresis System
Measured: % change will be determined on the day of treatment
Secondary outcomes (1)
Immune system activation
To assess the effect of oncopheresis on immune system activation
Measured: Immune system activation biomarkers will be followed for 7 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startSep 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will be their own controls
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viatar LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nigel Murray, MD, Principal investigator, Hospital de Carabineros
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058809
- Sponsor's protocol ID
- T30-0002
- Status last verified
- May 2018
- First submitted
- 16 Feb 2017
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Saftey and Efficacy of the Viatar™ Oncopheresis System in Removing Circulating Tumor Cells From Whole Blood
- ClinicalTrials.gov ID
- NCT03058809
- Acronym / sponsor ID
- T30-0002
- Conditions
- Metastatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Viatar LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 23 Feb 2017 (actual)
- 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 study will access the safety and efficacy of the Viatar™ Oncopheresis System to remove a meaningful quantity of circulating tumor cells from the blood of subjects' with breast, colon or prostate solid tumor cancers in a single treatment. CTC reduction will be measured as the change in circulating tumor cells as determined before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will be their own controls
| Arm | Type | Receives |
|---|---|---|
| Metastatic Breast, Colon and Prostate Cancer | Experimental | Device: OncopheresisMetastatic breast, colon or prostate cancer patients will have their CTC levels determined on 3 days before treatment with the Viatar Oncopheresis System to establish a baseline value, a pretreatment value, a post treatment value and on 4 additional instances over a period of 7 days post treatment to establish a CTC rebound profile using a validated CTC enumeration system. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Confirmed diagnosis of breast, colon or prostate cancer
- No prior cancer therapy or failed first line therapy
- >= 25 CTC per 7.5 mL of blood within 1 week prior to oncopheresis treatment
- > 1 month life expectancy
- Adequate baseline hematological function as assessed by the following laboratory values:
Key exclusion criteria (2 listed)
- Coagulation disorders and/or a history of thromboembolic complications, including known hypersensitivity to citrate: e.g., abnormal platelet count, prothrombin time and partial activated thromboplastin time and with a history of deep vein thrombus or pulmonary embolism
- Patients with known immunodeficiency virus (HIV)
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 |
|---|---|---|
| OncopheresisOncopheresis is a type of apheresis incorporating an extracorporeal blood circuit and a filter to separate circulating tumor cells from normal blood components. | Device | Metastatic Breast, Colon and Prostate Cancer |
Primary outcome
Change in Circulating Tumor Cells
Time frame: % change will be determined on the day of treatment
% change in enumerated circulating tumor cells after treatment with Viatar Oncopheresis System
1 secondary outcome
Immune system activation
Time frame: Immune system activation biomarkers will be followed for 7 days post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Steve Keaney contact
Nigel Murray, MD principal investigator
Hospital de Carabineros
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oncopheresis in people with Metastatic Cancer, run by Viatar LLC.
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 9 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael A Patz (9787128210, michael.patz@viatarctcsolutions.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Circulating Tumor Cells (time frame: % change will be determined on the day of treatment). 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 31 May 2018.