Solid TumorPhase 1NCT04673396
Phase I Clinical Study for Evaluation of Pharmacokinetic, Safety, Tolerance of Norcantharidin Lipid Microsphere for Injection in Patients With Solid Tumor
A Phase 1 study testing Norcantharidin Lipid Microsphere for Injection and Sodium Demethylcantharidate Injection in people with Solid Tumor, run by Beijing Nuokangda Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This study was designed as a single-center, open, non-randomized trial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Norcantharidin Lipid Microsphere for Injection and Sodium Demethylcantharidate Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2020to 1 Jul 2022
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years old, regardless of gender.
- Condition body mass index (BMI) = Weight (kg)/Height 2 (m2), the body mass index is in the range of 18-28 (Including the cut-off value).
- Patients with locally advanced or metastatic solid tumors that have been clearly diagnosed by histology/cytology, patients whose condition is stable after standard treatment, or those who have failed standard treatment.
- According to the Eastern Cooperative Oncology Group (ECOG) score of 0 to 2, the estimated survival time is ≥ 3 months.
- It has sufficient organ and bone marrow functions, defined as follows:
- Blood routine: white blood cell count (WBC) ≥ 4.0 × 109/L; neutrophil count (NEUT) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 100 × 109/L; hemoglobin concentration ≥ 9.0 g/ dL;
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- Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); for patients with liver cancer or liver metastases, ALT and AST ≤ 5 times ULN; Total bilirubin (TBIL) ≤ 1.5 × ULN;
- Renal function: blood creatinine (CREA) ≤ 1.5 × ULN;
- Heart function: LVEF ≥ 50%.
- Those who have used chemotherapeutics in the past need to stop the drug for more than 4 weeks (mitomycin or nitrosourea, need to stop for more than 6 weeks); have received surgery, molecular targeted therapy, and anti-tumor indications with Chinese medicine Those who need treatment should end at least 4 weeks, and those who have received palliative radiotherapy need more than 4 weeks of treatment.
- Any toxicity associated with previous anti-tumor treatments must have been restored to ≤ Grade 1 (except for hair loss).
- During the study period and within 3 months after the end of the administration, subjects with fertility (whether male or female) must receive effective contraceptive measures.
- With my consent and signed an informed consent form by myself or my legal representative.
Who cannot join
- Suffer from any clinically significant cardiovascular and cerebrovascular diseases within 3 months before taking the trial drug, including but not limited to myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass graft, congestive heart failure, Cerebrovascular accident (including transient ischemic attack).
- There is NCI-CTCAE grade ≥ grade 2 arrhythmia, any grade of atrial fibrillation that is not controlled, or the ECG found at the time of screening that the QT interval (QTc) for two consecutive corrections> 480ms.
- Any drug that may prolong the QTc interval or induce torsade de pointes ventricular tachycardia is required within 14 days before the first use of the test drug or during treatment.
- History of allergic diseases and severe drug allergy.
- Patients with uncontrolled tumor brain metastases with clinical symptoms.
- Patients with severe infections (including but not limited to progressive or active infections) (for example, intravenous infusion of antibiotics, antifungal or antiviral drugs, etc.).
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- Patients with severe medical diseases, such as cardiac dysfunction of grade II and above (NYHA standard), ischemic heart disease (such as myocardial infarction or angina), congestive heart failure and other cardiovascular diseases, poorly controlled diabetes (Fasting blood glucose ≥10mmol/L), poorly controlled hypertension (systolic blood pressure>150mmHg and/or diastolic blood pressure>100mmHg).
- Those who have bleeding tendency or are receiving thrombolysis or anticoagulation therapy.
- Active hepatitis (hepatitis B, hepatitis C) or known HIV infection.
- Other systemic anti-tumor treatments may be accepted during the study period.
- A clear history of neurological or mental disorders, including epilepsy or dementia.
- Have bad habits such as drug and alcohol abuse. Alcoholism refers to drinking behaviors of 4 or more times within about 2 hours. One-time drinking refers to drinking 150ml of wine, 350ml of beer, or 50ml of 80% liquor (or equivalent to the alcohol content).
- Women during pregnancy or lactation.
- Those who have received other drug clinical research within 1 month before the study.
- Other situations where the researcher thinks it is inappropriate to participate in this research.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, China Medical University
Shenyang, Liaoning, 110001
Yunpeng Liu, Ph.D, 13898865122, cmu_trial@163.com
About this study
This study was designed as a single-center, open, non-randomized trial.
Read the detailed description
In this study, patients with locally advanced or metastatic solid tumors were enrolled for a tolerance test and a pharmacokinetic study. The dosage increment principle of 3+3 was adopted. At the end of the tolerance test, 3 dose groups (low, medium and high) were selected to conduct pharmacokinetic studies after evaluation by the researchers on the premise of good safety, and at least 8 patients were included in each group for PK study (at least 8 patients in each group could be evaluated for PK ).
After the end of the experimental drug tolerance and pharmacokinetics study, the safety and pharmacokinetics of single dose administration were compared with that of sodium norcantharidate for injection in the dose range of clinical use.
- Conditions
- Solid Tumor
- Being tested
- Norcantharidin Lipid Microsphere for Injection, Sodium Demethylcantharidate Injection
- Keywords
- Norcantharidin Lipid Microsphere For Injection, Pharmacokinetics, Safety, Tolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norcantharidin Lipid Microsphere for InjectionDrug
Also called Tolerance,and Pharmacokinetic study
The test drug was added to 5% glucose injection to a final volume of 250 mL，and administered by instillation at a rate of 200 mL/h.
This product can be used alone or in combination with chemotherapy, and the dosage and time of administration vary with the chemotherapy regimen.
Sodium Demethylcantharidate InjectionDrug
Also called Comparative Pharmacokinetic Studies
Dissolve the reference drug with appropriate amount of sterile water for injection, and add 250 mL of 5% glucose injection for slow dripping.
| Study group | Role | What they receive |
|---|---|---|
| Tolerance test | Experimental | The design is based on 3+3 dose escalation: three subjects were enrolled in each dose group, administered once a day for 2 weeks, and were observed for 7 days after withdrawal. If dose-limiting toxicity (DLT) was not observed, the dose was incresed to the next dose group. If dose-limiting toxicity (DLT) was found in 2 or more patients in a given dose group, the climbing test was terminated and the dose was reduced by 1 dose. If there were only three subjects, three more subjects were observed, so that the MTD dose group had at least six evaluable subjects.If DLT occurs in 1 patient in a given dose group, 3 more subjects should be added to that dose group. If DLT occurs in 1 or more of these 3 subjects, the climb will be stopped and the dose group will be reduced by 1 dose group. If there are only 3 subjects, 3 more subjects will be observed, so that at least 6 patients in the MTD dose group can be evaluated. Receives: Drug: Norcantharidin Lipid Microsphere for Injection |
| Pharmacokinetic studies | Experimental | At the same time of tolerance test, blood PK sampling was performed. At the end of the tolerance test in each group, on the premise of good safety, and after evaluation by the researchers, additional cases were selected from the three dose groups (low, medium and high) for pharmacokinetic study, so as to ensure that at least 8 patients could be evaluated for PK in each group. Receives: Drug: Norcantharidin Lipid Microsphere for Injection |
| Comparative Study | Active comparator | It is planned to select the 20mg dose of norcantharidin sodium for injection to carry out pharmacokinetic study of 8 cases. The specific research design will be formulated after the tolerance and pharmacokinetic test of norcantharidin lipid microsphere injection is completed. Receives: Drug: Norcantharidin Lipid Microsphere for Injection; Drug: Sodium Demethylcantharidate Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Obtain directly according to the measured data of blood drug concentration-time.
Measured: ±1 minute
AUC 0-t
The area under the curve from the time of administration to the lowest detectable blood concentration: calculated by the linear trapezoidal rule.
Measured: ±1 minute
AUC 0-∞
Area under the curve from administration to extrapolation to infinity: AUC0-∞=AUC0-t+Ct/λz, Ct is the last measurable concentration, and λz is the elimination rate constant.
Measured: ±1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start22 Sep 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Single center, open, non-randomized trial design
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Nuokangda Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yunpeng Liu, Ph.D, Principal investigator, The First Affiliated Hospital, China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673396
- Sponsor's protocol ID
- DXNCTD2019001
- Status last verified
- Dec 2020
- First submitted
- 14 Dec 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study for Evaluation of Pharmacokinetic, Safety, Tolerance of Norcantharidin Lipid Microsphere for Injection in Patients With Solid Tumor
- ClinicalTrials.gov ID
- NCT04673396
- Acronym / sponsor ID
- DXNCTD2019001
- Conditions
- Solid Tumor
- Keywords
- Norcantharidin Lipid Microsphere For Injection, Pharmacokinetics, Safety, Tolerance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Beijing Nuokangda Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 17 Dec 2020 (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 was designed as a single-center, open, non-randomized trial.
Detailed description
In this study, patients with locally advanced or metastatic solid tumors were enrolled for a tolerance test and a pharmacokinetic study. The dosage increment principle of 3+3 was adopted. At the end of the tolerance test, 3 dose groups (low, medium and high) were selected to conduct pharmacokinetic studies after evaluation by the researchers on the premise of good safety, and at least 8 patients were included in each group for PK study (at least 8 patients in each group could be evaluated for PK ).
After the end of the experimental drug tolerance and pharmacokinetics study, the safety and pharmacokinetics of single dose administration were compared with that of sodium norcantharidate for injection in the dose range of clinical use.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Single center, open, non-randomized trial design
| Arm | Type | Receives |
|---|---|---|
| Tolerance test | Experimental | Drug: Norcantharidin Lipid Microsphere for InjectionThe design is based on 3+3 dose escalation: three subjects were enrolled in each dose group, administered once a day for 2 weeks, and were observed for 7 days after withdrawal. If dose-limiting toxicity (DLT) was not observed, the dose was incresed to the next dose group. If dose-limiting toxicity (DLT) was found in 2 or more patients in a given dose group, the climbing test was terminated and the dose was reduced by 1 dose. If there were only three subjects, three more subjects were observed, so that the MTD dose group had at least six evaluable subjects.If DLT occurs in 1 patient in a given dose group, 3 more subjects should be added to that dose group. If DLT occurs in 1 or more of these 3 subjects, the climb will be stopped and the dose group will be reduced by 1 dose group. If there are only 3 subjects, 3 more subjects will be observed, so that at least 6 patients in the MTD dose group can be evaluated. |
| Pharmacokinetic studies | Experimental | Drug: Norcantharidin Lipid Microsphere for InjectionAt the same time of tolerance test, blood PK sampling was performed. At the end of the tolerance test in each group, on the premise of good safety, and after evaluation by the researchers, additional cases were selected from the three dose groups (low, medium and high) for pharmacokinetic study, so as to ensure that at least 8 patients could be evaluated for PK in each group. |
| Comparative Study | Active comparator | Drug: Norcantharidin Lipid Microsphere for Injection, Drug: Sodium Demethylcantharidate InjectionIt is planned to select the 20mg dose of norcantharidin sodium for injection to carry out pharmacokinetic study of 8 cases. The specific research design will be formulated after the tolerance and pharmacokinetic test of norcantharidin lipid microsphere injection is completed. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18-70 years old, regardless of gender.
- Condition body mass index (BMI) = Weight (kg)/Height 2 (m2), the body mass index is in the range of 18-28 (Including the cut-off value).
- Patients with locally advanced or metastatic solid tumors that have been clearly diagnosed by histology/cytology, patients whose condition is stable after standard treatment, or those who have failed standard treatment.
- According to the Eastern Cooperative Oncology Group (ECOG) score of 0 to 2, the estimated survival time is ≥ 3 months.
- It has sufficient organ and bone marrow functions, defined as follows:
Key exclusion criteria (15 listed)
- Suffer from any clinically significant cardiovascular and cerebrovascular diseases within 3 months before taking the trial drug, including but not limited to myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass graft, congestive heart failure, Cerebrovascular accident (including transient ischemic attack).
- There is NCI-CTCAE grade ≥ grade 2 arrhythmia, any grade of atrial fibrillation that is not controlled, or the ECG found at the time of screening that the QT interval (QTc) for two consecutive corrections> 480ms.
- Any drug that may prolong the QTc interval or induce torsade de pointes ventricular tachycardia is required within 14 days before the first use of the test drug or during treatment.
- History of allergic diseases and severe drug allergy.
- Patients with uncontrolled tumor brain metastases with clinical symptoms.
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 |
|---|---|---|
| Norcantharidin Lipid Microsphere for InjectionAlso: Tolerance,and Pharmacokinetic studyThe test drug was added to 5% glucose injection to a final volume of 250 mL，and administered by instillation at a rate of 200 mL/h. This product can be used alone or in combination with chemotherapy, and the dosage and time of administration vary with the chemotherapy regimen. | Drug | Comparative Study, Pharmacokinetic studies, Tolerance test |
| Sodium Demethylcantharidate InjectionAlso: Comparative Pharmacokinetic StudiesDissolve the reference drug with appropriate amount of sterile water for injection, and add 250 mL of 5% glucose injection for slow dripping. | Drug | Comparative Study |
Primary outcome
Cmax
Time frame: ±1 minute
Obtain directly according to the measured data of blood drug concentration-time.
AUC 0-t
Time frame: ±1 minute
The area under the curve from the time of administration to the lowest detectable blood concentration: calculated by the linear trapezoidal rule.
AUC 0-∞
Time frame: ±1 minute
Area under the curve from administration to extrapolation to infinity: AUC0-∞=AUC0-t+Ct/λz, Ct is the last measurable concentration, and λz is the elimination rate constant.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Yunpeng Liu, Ph.D principal investigator
The First Affiliated Hospital, China Medical University
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 Norcantharidin Lipid Microsphere for Injection and Sodium Demethylcantharidate Injection in people with Solid Tumor, run by Beijing Nuokangda Pharmaceutical Technology Co., Ltd. at 1 site in China.
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 13 inclusion and 15 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 21 Dec 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunpeng Liu, Ph.D (13898865122, cmu_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: ±1 minute). The study lists 3 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 21 Dec 2020.