Metastatic Breast CancerPhase 1NCT03062007
Open-label Study of Safety, Tolerability and Pharmacokinetics of Multiple Doses of BI-CON-02 in Patients With HER2-positive Metastatic Breast Cancer, Previously Treated With Trastuzumab
A Phase 1 study testing BI-CON-02 in people with Metastatic Breast Cancer, run by Biointegrator LLC at 6 sites in Russia.
Trial summary
This study will evaluate the safety and tolerability of BI-CON-02 in patients with HER2-positive metastatic breast cancer, previously treated with trastuzumab The clinical trial protocol for BI-CON-02 prescribes a start dose of 0,3 mg/kg. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- BI-CON-02
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 6 sitesRussia
- Study dates
- Sep 2016to 5 Jun 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
- To participate in the clinical study, patients must comply to the following criteria:
- Signed patient's information sheet and informed consent form to participate in the study
- Females aged ≥ 18 years
- Histologically confirmed diagnosis of locally advanced or metastatic breast cancer.
- HER2-positive tumor status by results of immunohistochemistry (IHC3+) or hybridization in-situ (ISH), received at the local laboratory, experienced/certified to determine HER2 expression by means of accurate and validated methods.
- Disease progression during or after trastuzumab-based chemotherapy.
Show all 18Show fewer
- Previous chemotherapy on metastatic breast cancer.
- Requirements for laboratory parameters determined below:
- Hematology: Absolute neutrophil count:
- Platelets:
- Hemoglobin: ≥ 1500/mm3 (1.5 x 109 cells/L)
- 100 000/mm3 (100 x 109 cells/L)
- 9.0 g/dl
- Liver function: Total bilirubin:
- Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkalinephosphatase ≤ 1.5 x ULN
- ≤ 2.5 x ULN or ≤ 5.0 х ULN in case of liver and/or bones metastasis Renal function: Serum creatinine or GFR (according to Cocroft-Golt formula): ≤ 1.5 mg/dl > 60 ml/min
- Patients must have an ECOG status of 0, 1 or 2
- Women of childbearing potential (not sterile or in menopause less than 2 years) must be practicing an effective method of birth control during the whole period of the study and 6 months after the last administration of the investigational product. Effective methods of birth control include usage of a condom or diaphragm (barrier method) with spermicide.
Who cannot join
- The patient will be considered ineligible for the study in case she has any criteria listed here below:
- Clinically significant cardiovascular diseases:
- Myocardial infarction within 6 months before screening
- Unstable angina within 3 months before screening
- Congestive heart failure Class III or IV according to the New York Heart Association (NYHA) criteria
- Clinically significant ventricular arrhythmia, that have to be treated, including ventricular tachycardia, ventricular fibrillation, history of cardiac arrest
Show all 27Show fewer
- QTc interval > 460 ms (ECG) (calculated according to Fredericia formula), or a diagnosis of long QTc syndrome
- Ejection fraction of left ventricle ≤ 50% (EchoCG)
- Hypotension (systolic arterial blood pressure < 86 mm of mercury) or bradycardia with a heart rate of < 50 beats per min., except when caused by medications (e.g. beta-blockers)
- Uncontrolled arterial hypertension (systolic arterial blood pressure > 170 mm of mercury or diastolic arterial blood pressure > 105 mm of mercury)
- Troponins I ≥ 0.2 ng/ml
- Patients with known cerebral metastases or clinical signs of cerebral metastases.
- Patients with severe dyspnea at rest, or those who need additional oxygen therapy in everyday life.
- History of hypersensitivity to trastuzumab ≥ 3 severity level
- History of any toxicity related to trastuzumab administration that resulted in the termination of trastuzumab therapy.
- Peripheral neuropathy ≥ II severity level
- Bisphosphonate therapy for symptomatic hypercalcemia.
- Any chemotherapy, hormonotherapy, radiotherapy, immunotherapy or biological products therapy used for breast cancer treatment within 4 weeks before the first administration of the investigational product.
- Previous indication of doxorubicin in maximum cumulated dose > 360 mg/kg2, or its equivalent.
- Participation in other clinical studies or administration of other investigational products within 4 weeks before the first administration of the investigational product, or presence of on-going toxicities ≥ II grade according to CTCAE, related to any prior antitumour therapy (excluding alopecia).
- History of other malignancies with the exception of cervical carcinoma in situ or skin basal-cell carcinoma, that had undergone surgical removal and treatment within ≥ 5 years before the first administration of the investigational product.
- Presence of antibodies to human immunodeficiency virus (HIV), or hepatitis С virus (HCV), presence of HBsAg
- Active infection within 4 weeks before the first administration of the investigational product.
- Uncontrolled concomitant diseases and conditions, including mental or social, which, in the Investigator's opinion, may prevent the patient from participation in the study.
- Drug or alcohol abuse on the moment of screening or in the past, which, in the Investigator's opinion, makes the patient unsuitable for participation in the study.
- Pregnant or lactating women, or women who plan to get pregnant during the clinical study
- Inability to read or write, unwillingness to understand and comply with the procedures of the study protocol, as well as any other concomitant medical or serious mental conditions, that make the patient unsuitable for participation in the clinical study, limit the validity of informed consent receipt or may affect the patient's ability to participate in the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Russia6 sites
3. State Medical Preventive Institution "Kirov Region Clinical Oncological Dispensary"
Kirov, 610021
5. State Budgetary Public Healthcare Institution "Leningrad Region Oncological Dispensary", department of surgery
Leningrad Region Settlement Kuz'molovsky, 188663
1. Federal State Budgetary Institution "Russian Oncological Scientific Center n.a. N.N.Blokhin" of the Russian Academy of Medical Sciences.
Moscow, 115478
2. Moscow State Public Healthcare Institution "Moscow City Oncological Hospital #62 of the Moscow Public Healthcare Department"
Moscow Region, Krasnogorsk District, Settlement Istra, 143423
6. State Budgetary Public Healthcare Institution of the Nizhni Novgorod Region "Nizhni Novgorod Region Oncological Dispensary"
Nizhny Novgorod, 603081
4. State Budgetary Educational Institution of Higher Professional Education "Saint-Petersburg State Medical University n.a. academician I.P.Pavlov of the Federal Agency for Public Healthcare and Social Development"
Saint Petersburg, 197022
About this study
This study will evaluate the safety and tolerability of BI-CON-02 in patients with HER2-positive metastatic breast cancer, previously treated with trastuzumab The clinical trial protocol for BI-CON-02 prescribes a start dose of 0,3 mg/kg. After the Data and Safety Monitoring Committee evaluates the data of tolerability and safety of BI-CON-02, received during 3 weeks of investigational product therapy (Week 3, Day 1) and approves, extra doses can be used.
Once the safety of investigational product is confirmed, the dose will be increased in the subsequent cohorts. Planned doses - 0,3 mg/kg; 0,6 mg/kg; 1,2 mg/kg; 2,4 mg/kg; 3,6 mg/kg and 4,8 mg/kg.
- Conditions
- Metastatic Breast Cancer
- Being tested
- BI-CON-02
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI-CON-02Drug
BI-CON-02 prescribed as intravenous infusion once per 3 weeks. Investigational product therapy during 1 year (up to 18 cycles, duration of 21 days each).
| Study group | Role | What they receive |
|---|---|---|
| BI-CON-02 | Experimental | The start dose of BI-CON-02 will be 0,3 mg/kg and it will be possible to increase gradually BI-CON-02 doses up to 0,6 mg/kg; 1,2 mg/kg; 2,4 mg/kg; 3,6 mg/kg and 4,8 mg/kg for subsequent dose cohorts. A possibility to include a new dose cohort in the study will be considered by the Data and Safety Monitoring Committee, basing on the data of BI-CON-02 safety and tolerability, received at the Visit (Week 3, Day1) in the previous dose cohort (3 weeks after - 21st day of therapy). Receives: Drug: BI-CON-02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) Safety and tolerability of multiple doses of Safety and tolerability of multiple doses of BI-CON-02
The number of patients with treatment-related AEs assessed by CTCAE, abnormal laboratory values and instrumental tests (ECG).
Measured: Up to Week 55
Maximum tolerated dose (MTD) or recommended dose (RD) of BI-CON-02
MTD is defined as maximum dose at which DLT occurs in more than 1 patient of 6
Measured: At Week 3 Day 1
Secondary outcomes (6)
Area under the plasma concentration versus time curve (AUC)
PK analysis of multiple doses of BI-CON-02
Measured: Up to 55 weeks
Immunogenetics of BI-CON-02
Assessment of Antibodies to BI-CON-02 in blood samples
Measured: Up to Week 55
Peak Plasma Concentration (Cmax)
PK analysis of multiple doses of BI-CON-02
Measured: Up to 55 weeks
Elimination half-life (T1/2)
PK analysis of multiple doses of BI-CON-02
Measured: Up to 55 weeks
Volume of distribution at steady state (Vss)
PK analysis of multiple doses of BI-CON-02
Measured: Up to 55 weeks
Clearance (CL)
PK analysis of multiple doses of BI-CON-02
Measured: Up to 55 weeks
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 2016
- Primary completion5 Jun 2017
- Study completion5 Jun 2017
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biointegrator LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062007
- Sponsor's protocol ID
- ONC-BICON02-01
- Status last verified
- Feb 2017
- First submitted
- 8 Feb 2017
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study of Safety, Tolerability and Pharmacokinetics of Multiple Doses of BI-CON-02 in Patients With HER2-positive Metastatic Breast Cancer, Previously Treated With Trastuzumab
- ClinicalTrials.gov ID
- NCT03062007
- Acronym / sponsor ID
- ONC-BICON02-01
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Biointegrator LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- 5 Jun 2017 (actual)
- Study completion
- 5 Jun 2017 (actual)
- 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 evaluate the safety and tolerability of BI-CON-02 in patients with HER2-positive metastatic breast cancer, previously treated with trastuzumab The clinical trial protocol for BI-CON-02 prescribes a start dose of 0,3 mg/kg. After the Data and Safety Monitoring Committee evaluates the data of tolerability and safety of BI-CON-02, received during 3 weeks of investigational product therapy (Week 3, Day 1) and approves, extra doses can be used.
Once the safety of investigational product is confirmed, the dose will be increased in the subsequent cohorts. Planned doses - 0,3 mg/kg; 0,6 mg/kg; 1,2 mg/kg; 2,4 mg/kg; 3,6 mg/kg and 4,8 mg/kg.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BI-CON-02 | Experimental | Drug: BI-CON-02The start dose of BI-CON-02 will be 0,3 mg/kg and it will be possible to increase gradually BI-CON-02 doses up to 0,6 mg/kg; 1,2 mg/kg; 2,4 mg/kg; 3,6 mg/kg and 4,8 mg/kg for subsequent dose cohorts. A possibility to include a new dose cohort in the study will be considered by the Data and Safety Monitoring Committee, basing on the data of BI-CON-02 safety and tolerability, received at the Visit (Week 3, Day1) in the previous dose cohort (3 weeks after - 21st day of therapy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Signed patient's information sheet and informed consent form to participate in the study
- Females aged ≥ 18 years
- Histologically confirmed diagnosis of locally advanced or metastatic breast cancer.
- HER2-positive tumor status by results of immunohistochemistry (IHC3+) or hybridization in-situ (ISH), received at the local laboratory, experienced/certified to determine HER2 expression by means of accurate and validated methods.
- Disease progression during or after trastuzumab-based chemotherapy.
Key exclusion criteria (27 listed)
- The patient will be considered ineligible for the study in case she has any criteria listed here below:
- Clinically significant cardiovascular diseases:
- Patients with known cerebral metastases or clinical signs of cerebral metastases.
- Patients with severe dyspnea at rest, or those who need additional oxygen therapy in everyday life.
- History of hypersensitivity to trastuzumab ≥ 3 severity level
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 |
|---|---|---|
| BI-CON-02BI-CON-02 prescribed as intravenous infusion once per 3 weeks. Investigational product therapy during 1 year (up to 18 cycles, duration of 21 days each). | Drug | BI-CON-02 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) Safety and tolerability of multiple doses of Safety and tolerability of multiple doses of BI-CON-02
Time frame: Up to Week 55
The number of patients with treatment-related AEs assessed by CTCAE, abnormal laboratory values and instrumental tests (ECG).
Maximum tolerated dose (MTD) or recommended dose (RD) of BI-CON-02
Time frame: At Week 3 Day 1
MTD is defined as maximum dose at which DLT occurs in more than 1 patient of 6
6 secondary outcomes
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to 55 weeks
Immunogenetics of BI-CON-02
Time frame: Up to Week 55
Peak Plasma Concentration (Cmax)
Time frame: Up to 55 weeks
Elimination half-life (T1/2)
Time frame: Up to 55 weeks
Volume of distribution at steady state (Vss)
Time frame: Up to 55 weeks
Clearance (CL)
Time frame: Up to 55 weeks
Results and safety
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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.
6 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 BI-CON-02 in people with Metastatic Breast Cancer, run by Biointegrator LLC at 6 sites in Russia.
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 18 inclusion and 27 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 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Russia. 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: Sponsor's decision). 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?
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) Safety and tolerability of multiple doses of Safety and tolerability of multiple doses of BI-CON-02 (time frame: Up to Week 55). The study lists 2 primary outcomes in all. 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 16 Jul 2019.