Tumors, BreastPhase 1NCT02496065
Exploratory Study of Safety and ex Vivo Fluorescence of BLZ-100 in Adult Subjects With Solid Tumors Undergoing Surgery
A Phase 1 study testing BLZ-100 in people with Tumors, Breast, run by Blaze Bioscience Inc. at 2 sites in United States.
Trial summary
Surgery is the primary treatment modality for many types of cancer and the extent of surgical resection is directly related to patient survival. However, it is often difficult for surgeons to distinguish normal from neoplastic tissue or to detect metastatic disease or tumor-infiltrated lymph nodes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors, Breast
- What is being tested?
- BLZ-100
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject aged 18 years or older.
- Diagnosed solid tumor scheduled for surgical excision. Subjects with recurrent disease will be eligible only if the duration between last tumor surgery and scheduled new surgery is ≥3 months.
- Able to provide written informed consent.
- If of child-bearing potential, agree to continued use of two reliable methods of contraceptive from study entry (time of informed consent) through 30 days after BLZ-100 administration. Male subjects with vasectomy do not need to use a second form of contraceptive.
- Available for all study visits and able to comply with all study requirements.
Who cannot join
- Suspected central nervous system (CNS) tumor(s) or sarcoma.
- Female who is lactating/breastfeeding.
- Female with a positive pregnancy test or who is planning to become pregnant during the duration of the study.
- Karnofsky Performance Status of <60%.
- Any of the following laboratory abnormalities at Screening:
- Neutrophil count <1.5 x 109/L
Show all 24Show fewer
- Platelets <75 x 109/L
- Hemoglobin <10 g/dL (may be determined following transfusion)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN)
- Total bilirubin >1.5 x ULN (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)
- International Normalized Ratio (INR) >1.5 x ULN
- Creatinine >1.5 x ULN
- QTc prolongation >480 msec.
- History of hypersensitivity or allergic reactions requiring corticosteroids, epinephrine, and/or hospitalization.
- Uncontrolled asthma or asthma requiring oral corticosteroids.
- Known or suspected sensitivity to diagnostic imaging contrast agents.
- Known or suspected sensitivity to indocyanine green (ICG).
- Unstable angina, myocardial infarction, known or suspected transient ischemic events, or stroke within 24 weeks of start of Screening.
- Uncontrolled hypertension.
- Initiation of new photosensitizing drugs within 30 days of Screening.
- Use of any ongoing medications which might generate fluorescence or, according to the medication label, might generate a photochemical reaction. These include haematoporphyrin derivatives and purified fractions, Photofrin®, and the precursors of protoporphyrin IX (5-Aminolevulinic acid) used in Gliolan or Hexvix.
- Receipt of an investigational drug or device within 30 days of enrollment.
- Prior treatment with BLZ-100.
- Any concurrent condition, including psychological and social situations, which, in the opinion of the investigator, would adversely impact the subject or the interpretation of the study data.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Overlake Medical Center
Bellevue, Washington, 98004
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Official title: A Phase 1 Exploratory Study of the Safety and ex Vivo Fluorescence of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Solid Tumors Undergoing Surgery
Surgery is the primary treatment modality for many types of cancer and the extent of surgical resection is directly related to patient survival. However, it is often difficult for surgeons to distinguish normal from neoplastic tissue or to detect metastatic disease or tumor-infiltrated lymph nodes. In some sites, surgical precision is also required to avoid damage to critical normal tissues. The purpose of this exploratory study is to evaluate the intra-operative and ex vivo fluorescence of BLZ-100 in tumor samples from subjects with breast cancer.
Read the detailed description
Subjects diagnosed to have breast cancer for which surgical resection is clinically indicated will be enrolled in this study.
Upon obtaining signed informed consent, subjects will enter a Screening Period for up to 14 days to determine eligibility. Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to participate in the study.
All subjects entered into the study will be required to arrive at the hospital (or Phase 1 unit if applicable) for BLZ-100 administration at least 2 hours before their scheduled surgical procedure. Following administration of BLZ-100, subjects will be continuously monitored for safety and any allergic reaction occurrence for 30 minutes; thereafter, subjects will be evaluated for 7 days after drug administration. All subjects will be followed for at least 30 days following drug administration to monitor for SAEs.
Tumor samples will be imaged in situ and ex vivo with the SIRIS imaging system or equivalent device, processed, and sent to a central laboratory to be evaluated for ex vivo fluorescence using the Odyssey® CLx imaging system.
- Conditions
- Tumors, Breast
- Being tested
- BLZ-100
- Keywords
- breast cancer, BLZ-100, Tumor Paint, breast tumors
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLZ-100Drug
Also called Tumor Paint
| Study group | Role | What they receive |
|---|---|---|
| BLZ-100 | Experimental | Not described Receives: Drug: BLZ-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters. These assessments will be used to determine whether a subject experienced an AE.
Measured: Seven days after study drug administration
Secondary outcomes (2)
Fluorescent signal from excised tumor surgical specimens
Ex vivo fluorescence of excised tumor specimens will be evaluated with the SIRIS or equivalent imaging device and Odyssey imaging system.
Measured: Post-tumor excision (approximately 2 hours post BLZ-100 dosing)
Change of concentration of BLZ-100 in the blood
BLZ-100 levels in blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters.
Measured: 5, 15, and 30 minutes post BLZ-100 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumors, BreastStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blaze Bioscience Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristi M Harrington, MD, Principal investigator, Overlake Medical Center, Overlake Medical Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496065
- Sponsor's protocol ID
- BB-005
- Status last verified
- Jul 2017
- First submitted
- 8 Jul 2015
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Exploratory Study of the Safety and ex Vivo Fluorescence of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Solid Tumors Undergoing Surgery
- ClinicalTrials.gov ID
- NCT02496065
- Acronym / sponsor ID
- BB-005
- Conditions
- Tumors, Breast
- Keywords
- breast cancer, BLZ-100, Tumor Paint, breast tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Blaze Bioscience Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 14 Jul 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.
Surgery is the primary treatment modality for many types of cancer and the extent of surgical resection is directly related to patient survival. However, it is often difficult for surgeons to distinguish normal from neoplastic tissue or to detect metastatic disease or tumor-infiltrated lymph nodes. In some sites, surgical precision is also required to avoid damage to critical normal tissues. The purpose of this exploratory study is to evaluate the intra-operative and ex vivo fluorescence of BLZ-100 in tumor samples from subjects with breast cancer.
Detailed description
Subjects diagnosed to have breast cancer for which surgical resection is clinically indicated will be enrolled in this study.
Upon obtaining signed informed consent, subjects will enter a Screening Period for up to 14 days to determine eligibility. Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to participate in the study.
All subjects entered into the study will be required to arrive at the hospital (or Phase 1 unit if applicable) for BLZ-100 administration at least 2 hours before their scheduled surgical procedure. Following administration of BLZ-100, subjects will be continuously monitored for safety and any allergic reaction occurrence for 30 minutes; thereafter, subjects will be evaluated for 7 days after drug administration. All subjects will be followed for at least 30 days following drug administration to monitor for SAEs.
Tumor samples will be imaged in situ and ex vivo with the SIRIS imaging system or equivalent device, processed, and sent to a central laboratory to be evaluated for ex vivo fluorescence using the Odyssey® CLx imaging system.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BLZ-100 | Experimental | Drug: BLZ-100 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subject aged 18 years or older.
- Diagnosed solid tumor scheduled for surgical excision. Subjects with recurrent disease will be eligible only if the duration between last tumor surgery and scheduled new surgery is ≥3 months.
- Able to provide written informed consent.
- If of child-bearing potential, agree to continued use of two reliable methods of contraceptive from study entry (time of informed consent) through 30 days after BLZ-100 administration. Male subjects with vasectomy do not need to use a second form of contraceptive.
- Available for all study visits and able to comply with all study requirements.
Key exclusion criteria (24 listed)
- Suspected central nervous system (CNS) tumor(s) or sarcoma.
- Female who is lactating/breastfeeding.
- Female with a positive pregnancy test or who is planning to become pregnant during the duration of the study.
- Karnofsky Performance Status of <60%.
- Any of the following laboratory abnormalities at Screening:
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 |
|---|---|---|
| BLZ-100Also: Tumor Paint | Drug | BLZ-100 |
Primary outcome
Number of participants with adverse events
Time frame: Seven days after study drug administration
Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters. These assessments will be used to determine whether a subject experienced an AE.
2 secondary outcomes
Fluorescent signal from excised tumor surgical specimens
Time frame: Post-tumor excision (approximately 2 hours post BLZ-100 dosing)
Change of concentration of BLZ-100 in the blood
Time frame: 5, 15, and 30 minutes post BLZ-100 administration
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 13 Jul 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.
Kristi M Harrington, MD principal investigator
Overlake Medical Center, Overlake Medical Clinics
2 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 BLZ-100 in people with Tumors, Breast, run by Blaze Bioscience Inc. at 2 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 5 inclusion and 24 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 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Number of participants with adverse events (time frame: Seven days after study drug administration). 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 13 Jul 2017.