Breast CancerPhase 1NCT02391194
Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery
A Phase 1 study testing AVB-620 in people with Breast Cancer, run by Avelas Biosciences, Inc. at 3 sites in United States.
Trial summary
This is a Phase 1, open-label, dose escalation study in women with primary, non-recurrent breast cancer undergoing surgery. AVB-620 will be administered prior to surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- AVB-620
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2015to Jan 2017
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ductal carcinoma in situ (DCIS) or Stage I-III, primary invasive carcinoma of the breast
- Primary surgical treatment is planned to be a mastectomy or lumpectomy. Sentinel lymph node (LN) biopsy or axillary LN dissection (ALND) is planned as part of the subject's therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate renal function
- Lab values (hematology and chemistry) within institution's normal laboratory limits
- Willing to remain on-site for approximately 24 hours after administration of AVB-620 or, if required, stay overnight after the surgical procedure
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- If the subject received neoadjuvant therapy, residual tumor is present (to be determined by the primary surgeon)
- If the subject received prior anthracycline therapy, the left ventricular ejection fraction (LVEF) must be within institution's normal limits
- Subject has the ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Recurrent ipsilateral breast cancer
- Prior neoadjuvant chemotherapy or biologic therapy for current clinically or biopsy-proven node positive breast cancer within 4 weeks before the planned surgery.
- Open surgery in the ipsilateral breast within 1 year of AVB-620 administration
- History of radiation therapy to ipsilateral breast
- Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events, and/or heart failure within 1 year of AVB-620 administration
- Diagnosis of autoimmune disorders
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- History of drug-related anaphylactic reactions or allergic reactions; subjects with an active diagnosis of uncontrolled airway hyperactivity, uncontrolled asthma, or asthma requiring oral corticosteroids will be excluded
- History of renal disease or current evidence of renal disease
- Current diagnosis of any other active or clinically significant non-breast cancer
- Systemic investigational drug of any kind within 6 weeks of AVB-620 administration
- Pregnant or breast feeding
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Moores UC San Diego Cancer Center
La Jolla, California, 92093
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
Stanford Hospitals and Clinics
Stanford, California, 94305
About this study
Official title: A Phase 1 Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery
This is a Phase 1, open-label, dose escalation study in women with primary, non-recurrent breast cancer undergoing surgery. AVB-620 will be administered prior to surgery.
Read the detailed description
This study will examine the safety and tolerability of AVB-620 administered as an IV infusion to women with primary, non-recurrent breast cancer undergoing surgery. The study will also characterize the pharmacokinetics of AVB-620 in this subject population and determine the dose of AVB-620 needed to generate a fluorescence signal in tumor and lymph node tissue to enable fluorescence recordings and image analysis with an imaging system. The study will also evaluate the effect of timing of AVB-620 administration, relative to surgery, on fluorescence characteristics.
- Conditions
- Breast Cancer
- Being tested
- AVB-620
- Keywords
- AVB-620, stage I, newly diagnosed, breast cancer, stage II, stage III, ductal carcinoma in situ
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVB-620Drug
| Study group | Role | What they receive |
|---|---|---|
| AVB-620 | Experimental | Eligible subjects will receive a single dose of AVB-620 as an intravenous infusion before the surgical procedure. Receives: Drug: AVB-620 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of AVB-620 as assessed by the incidence of adverse events and abnormal laboratory values
The incidence, nature and severity of adverse events and abnormal laboratory values will be collected and analyzed in the evaluation of the safety of AVB-620.
Measured: 30 days
Secondary outcomes (1)
Characterize the pharmacokinetic profile of AVB-620
The pharmacokinetics (PK) of AVB-620 will be characterized by collecting and reviewing individual subject plasma concentrations and primary parameters, including clearance, Cmax, Cmin, and distribution.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avelas Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391194
- Sponsor's protocol ID
- AVB620-C-001
- Status last verified
- Mar 2017
- First submitted
- 20 Feb 2015
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery
- ClinicalTrials.gov ID
- NCT02391194
- Acronym / sponsor ID
- AVB620-C-001
- Conditions
- Breast Cancer
- Keywords
- AVB-620, stage I, newly diagnosed, breast cancer, stage II, stage III, ductal carcinoma in situ
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Avelas Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 18 Mar 2015 (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 Phase 1, open-label, dose escalation study in women with primary, non-recurrent breast cancer undergoing surgery. AVB-620 will be administered prior to surgery.
Detailed description
This study will examine the safety and tolerability of AVB-620 administered as an IV infusion to women with primary, non-recurrent breast cancer undergoing surgery. The study will also characterize the pharmacokinetics of AVB-620 in this subject population and determine the dose of AVB-620 needed to generate a fluorescence signal in tumor and lymph node tissue to enable fluorescence recordings and image analysis with an imaging system. The study will also evaluate the effect of timing of AVB-620 administration, relative to surgery, on fluorescence characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AVB-620 | Experimental | Drug: AVB-620Eligible subjects will receive a single dose of AVB-620 as an intravenous infusion before the surgical procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ductal carcinoma in situ (DCIS) or Stage I-III, primary invasive carcinoma of the breast
- Primary surgical treatment is planned to be a mastectomy or lumpectomy. Sentinel lymph node (LN) biopsy or axillary LN dissection (ALND) is planned as part of the subject's therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate renal function
- Lab values (hematology and chemistry) within institution's normal laboratory limits
Key exclusion criteria (11 listed)
- Recurrent ipsilateral breast cancer
- Prior neoadjuvant chemotherapy or biologic therapy for current clinically or biopsy-proven node positive breast cancer within 4 weeks before the planned surgery.
- Open surgery in the ipsilateral breast within 1 year of AVB-620 administration
- History of radiation therapy to ipsilateral breast
- Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events, and/or heart failure within 1 year of AVB-620 administration
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 |
|---|---|---|
| AVB-620 | Drug | AVB-620 |
Primary outcome
Safety of AVB-620 as assessed by the incidence of adverse events and abnormal laboratory values
Time frame: 30 days
The incidence, nature and severity of adverse events and abnormal laboratory values will be collected and analyzed in the evaluation of the safety of AVB-620.
1 secondary outcome
Characterize the pharmacokinetic profile of AVB-620
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AVB-620 in people with Breast Cancer, run by Avelas Biosciences, Inc. at 3 sites in United States.
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 11 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: finished, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety of AVB-620 as assessed by the incidence of adverse events and abnormal laboratory values (time frame: 30 days). 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 22 Mar 2017.