Advanced Solid TumorsPhase 1NCT04778839
Study of Paclitaxel Micelles for Injection in Chinese Patients With Advanced Solid Tumors.
A Phase 1 study testing Paclitaxel Micelles for Injection and Paclitaxel injection in people with Advanced Solid Tumors, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
A Phase I Study of Dose Escalation and Dose Expansion To Evaluate the Safety、Tolerability、Pharmacokinetics and Preliminary Efficacy of Paclitaxel Micelles for Injection in Chinese Patients With Advanced Solid Tumor. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- Paclitaxel Micelles for Injection and Paclitaxel injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2021to 30 Jun 2026
- 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
- Participants are required to meet all the criteria below in order to be included in the trial:
- Confirmed diagnosis of advanced solid tumors by histological or cytological examination, participants have no effective standard anticancer therapy available or is failed to standard anticancer therapy.
- Male or female patient, aged 18 ~ 70 years.
- Life expectancy ≥ 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Participants with at least 1 measurable tumor lesion and/or assessable non-measurable lesion based on RECIST 1.1.
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- No radiotherapy, chemotherapy, immunotherapy or other anti-tumor therapy (such as experimental drugs, biological agents, Chinese herbal medicine, etc.), surgical treatment (except diagnostic biopsy), or complete recovery from previous surgery within 4 weeks prior to enrollment, and no surgical operation was planned during the study period.
- No severe hematopoietic abnormalities(no blood transfusion, no blood products, no granulocyte colony-stimulating factor, platelet stimulating factor, or other hematopoietic growth factors were corrected within 14 days prior to the screening phase laboratory examination):Hb≥90g/L , ANC≥1.5×109/L , PLT≥100×109/L.
- No serious organic disease of heart, liver or kidney:LVEF≥50% ; ALT(Alanine aminotransferase) or AST(Aspartate transaminase)≤2.5×upper limit of normal(ULN)(for patients with hepatic metastases, ALT or AST≤5 × ULN); TBIL(Total bilirubin)≤1.5×ULN; creatinine≤1.5×ULN and CL≥ 60 mL/min[The calculation formula was as follows: CCR (140- age)× body weight (kg) /0.818× SCR (μmol/L), and female was calculated as ×0.85].
- The coagulation function is normal:PT、APTT and INR≤1.5×ULN。
- Participants (including partners) who are willing to follow reliable contraceptive measures during the study and until 3 months after the last dosing（such as intrauterine devices [IUDs], birth control pills or condoms）.Women of child-bearing age must be negative for serum HCG within 14 days prior to study enrolment and must be non-lactating。
- Participants with voluntarily signature Informed Consent Form (ICF) before the test, and have a full understanding of the test content, process and possible adverse reactions.
- Participants with good compliance, were available for follow-up, and volunteered to comply with study regulations.
Who cannot join
- Eligible participants must not meet any of the following exclusion criteria:
- Patients with the toxicity of previous antitumor therapy did not return to grade 1 or below (CTCAE 5.0 grade >1, excluding toxicity such as alopecia and other toxicity judged by investigators to be of no safety risk).
- Patients with (including suspected) an allergic history to Paclitaxel, or any of its components, or allergic constitution (excluding mild asymptomatic seasonal allergy).
- Patients with bleeding tendency or who are receiving thrombolytic or anticoagulant therapy.
- Patients who had been treated with paclitaxel and were determined by the researchers to be resistant.
- Patients with active central nervous system metastases,But patients with BMs who have received prior treatment and the metastases were stable can participate in the study.
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- Patients with cerebrovascular accident or transient ischemic attack in the previous 6 months were screened.
- People with active infection and need anti-infection or antiviral treatment.
- Patients have suffered from other malignant cancers within 5 years (except for cured basal cell carcinoma and cervical carcinoma in situ).
- Concomitant diseases, as determined by the investigator, that seriously endangers the safety of subjects or affects their completion of the test(such as gastrointestinal bleeding, intestinal obstruction, intestinal paralysis, interstitial pneumonia, pulmonary fibrosis, etc).
- Patients with a clear history of neurological or psychiatric disorders (including epilepsy and dementia).
- Patients who have used any drugs that is CYP2C8 and/or CYP3A4 inducer or inhibitor Within 30 days before use of the test drug(including ketoconazole and other imidazole antifungal agents, verapamil, diazepam, quinidine, cyclosporine, teniposide, etoposide, vincrine, testosterone, 17-α diethylstilbestrol, retinoic acid, quercetin, etc).
- Patients who received blood transfusion and transfusion of blood products, such as albumin, within 2 weeks prior to trial.
- Patients with peripheral neuropathy above grade II.
- Patients with history of myocardial infarction(within 6 months prior to enrollment) ,severe or unstable angina, coronary or peripheral artery bypass grafting or congestive heart-failure (CHF) at NYHA 3-4 level ;and patients with history of uncontrollable hypertension, arrhythmias considered clinically significant by the investigator, or electrocardiogram (ECG) abnormalities.
- HIV infection, or active HBV infection (HBsAg and/or HBcAb positive, with peripheral blood HBV DNA ≥1 x 103 IU/ mL), or active HCV infection (HCV antibody positive, HCV RNA≥500 IU/ mL).
- Alcoholics (drinking more than 14 standard units per week. 1 standard unit contains 14g alcohol,such as 360mL beer or 45mL spirits with 40% alcohol or 150mL wine)within 2 weeks before screening, or patients with drug abuse.
- Patients who participated in other study within the last 1 month.
- Pregnant or nursing women.
- Patients who are thought to be unsuitable for participating in the trial by the researchers because of other factors.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital,ZheJiang Univercity
Hanzhou, Zhejiang, 310000
Jian Liu, Master, 13958054006, lindaliu87@zju.edu.com
About this study
Official title: A Phase I Study of Dose Escalation and Dose Expansion To Evaluate the Safety、Tolerability、Pharmacokinetics and Efficacy of Paclitaxel Micelles for Injection in Chinese Patients With Advanced Solid Tumor.
A Phase I Study of Dose Escalation and Dose Expansion To Evaluate the Safety、Tolerability、Pharmacokinetics and Preliminary Efficacy of Paclitaxel Micelles for Injection in Chinese Patients With Advanced Solid Tumor.
Read the detailed description
The study will be conducted in two parts. The first part is dose escalation and the second part is dose Expansion.During the course of dose escalation, 18-27 subjects will be enrolled to assess the safety、tolerability、pharmacokinetics、preliminary efficacy ,and determine the dose-limiting toxicity (DLT) and maximum tolerated dose(MTD) of Paclitaxel Micelles for Injection, and explore phase II clinical dosages. The second part will be adjusted according to the result of the first part. It will be divided into 4 groups, including advanced breast cancer group, ovarian cancer group, non-small cell lung cancer group and gastric cancer group, with 20 subjects in each group, to further evaluate the safety, tolerance, PK and anti-tumor activity of paclitaxel micelle.
- Conditions
- Advanced Solid Tumors
- Being tested
- Paclitaxel Micelles for Injection, Paclitaxel injection
- Keywords
- Breast cancer, ovarian cancer, non-small cell lung cancer, gastric cancer, Paclitaxel Micelles
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel Micelles for InjectionDrug
Paclitaxel Micelles for Injection was intravenously administrated for three hours, three weeks constituted one course of treatment.
Paclitaxel injectionDrug
Paclitaxel Injection was intravenously administrated for three hours, three weeks constituted one course of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel Micelles for Injection | Experimental | In the First Period, Only three Participants in the first dose group were randomly assigned to 175 mg/m2 paclitaxel micelle for injection at a 1:1 rate.175 mg/m2, 260 mg/m2, 320 mg/m2, and 390 mg/m2 of paclitaxel micelle for Injection was intravenously administrated for three hours,three weeks constituted one course of treatment. Receives: Drug: Paclitaxel Micelles for Injection |
| Paclitaxel Injection | Active comparator | three Participants were randomly assigned to 175 mg/m2 paclitaxel Injection,175 mg/m2 of conventional Paclitaxel Injection was intravenously administrated for three hours, three weeks constituted one course of treatment. Receives: Drug: Paclitaxel injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of Paclitaxel Micelles for Injection in dose ascending and dose extension as measured by assessment of maximum tolerated dose (MTD) and dose limiting toxicity (DLT).
MTD was determined as the dose where more than 2 out of 6 subjects experienced DLT
Measured: 2 years
The recommended dose for the phase II study
Determined as the recommended dose for a phase 2 study based on the adverse events and toxicities at each dose groups
Measured: 2 years
Secondary outcomes (13)
Cmax of Paclitaxel Micelles for Injection
Defined as maximum observed plasma concentration
Measured: Cycles 1(each cycle is 21 days) ,Day1 to Day4.
Tmax of Paclitaxel Micelles for Injection
Defined as time to maximum plasma concentration
Measured: Cycles 1(each cycle is 21 days) ,Day1 to Day4.
AUC0-t of Paclitaxel Micelles for Injection
Defined as area under plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration
Measured: Cycles 1(each cycle is 21 days), Day1 to Day4.
AUC0-inf of Paclitaxel Micelles for Injection
Defined as area under plasma concentration-time curve from Hour 0 to infinity
Measured: Cycles 1(each cycle is 21 days) ,Day1 to Day4.
λz of Paclitaxel Micelles for Injection
Defined as elimination rate constant
Measured: Cycles 1(each cycle is 21 days), Day1 to Day4.
t½ of Paclitaxel Micelles for Injection
Defined as the apparent plasma terminal phase disposition half-life
Measured: Cycles 1(each cycle is 21 days), Day1 to Day4.
CL of Paclitaxel Micelles for Injection
Defined as apparent clearance
Measured: Cycles 1(each cycle is 21 days), Day1 to Day4.
Vz of Paclitaxel Micelles for Injection
Defined as apparent volume of distribution
Measured: Cycles 1(each cycle is 21 days), Day1 to Day4.
%AUCex of Paclitaxel Micelles for Injection
Defined as AUC Extrapolated Percentage
Measured: Cycles 1(each cycle is 21 days), Day1 to Day4.
Objective response rate (ORR) of Paclitaxel Micelles
PR+CR,Imaging evaluations were performed with CT/MRI chest, abdominal, and pelvic scans
Measured: Baseline to date of first documented progression or date of the patients drop out of the study, up to 24 months.
Disease Control Rate (DCR) of Paclitaxel Micelles
PR+CR+SD,Imaging evaluations were performed with CT/MRI chest, abdominal, and pelvic scans
Measured: Baseline to date of first documented progression or date of the patients drop out of the study, up to 24 months.
Progression-free survival (PFS) of Paclitaxel Micelles
Imaging evaluations were performed with CT/MRI chest, abdominal, and pelvic scans
Measured: Baseline to date of first documented progression or date of the patients drop out of the study, up to 24 months.
Duration of remission (DOR) of Paclitaxel Micelles
Imaging evaluations were performed with CT/MRI chest, abdominal, and pelvic scans
Measured: Baseline to date of first documented progression or date of the patients drop out of the study, up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start4 Mar 2021
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Dihua Biotechnology Co., LTD.
- Responsible party
- Sponsor
- Investigators
- jian liu, master, Principal investigator, The First Affiliated Hospital,ZheJiang Univercityxiaochen zhang, docter, Principal investigator, The First Affiliated Hospital,ZheJiang Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778839
- Sponsor's protocol ID
- HZDH20-002
- Status last verified
- Sep 2024
- First submitted
- 19 Feb 2021
- Last updated
- 6 Aug 2025
- 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 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Dose Escalation and Dose Expansion To Evaluate the Safety、Tolerability、Pharmacokinetics and Efficacy of Paclitaxel Micelles for Injection in Chinese Patients With Advanced Solid Tumor.
- ClinicalTrials.gov ID
- NCT04778839
- Acronym / sponsor ID
- HZDH20-002
- Conditions
- Advanced Solid Tumors
- Keywords
- Breast cancer, ovarian cancer, non-small cell lung cancer, gastric cancer, Paclitaxel Micelles
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Hangzhou Dihua Biotechnology Co., LTD.
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 3 Mar 2021 (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.
A Phase I Study of Dose Escalation and Dose Expansion To Evaluate the Safety、Tolerability、Pharmacokinetics and Preliminary Efficacy of Paclitaxel Micelles for Injection in Chinese Patients With Advanced Solid Tumor.
Detailed description
The study will be conducted in two parts. The first part is dose escalation and the second part is dose Expansion.During the course of dose escalation, 18-27 subjects will be enrolled to assess the safety、tolerability、pharmacokinetics、preliminary efficacy ,and determine the dose-limiting toxicity (DLT) and maximum tolerated dose(MTD) of Paclitaxel Micelles for Injection, and explore phase II clinical dosages. The second part will be adjusted according to the result of the first part. It will be divided into 4 groups, including advanced breast cancer group, ovarian cancer group, non-small cell lung cancer group and gastric cancer group, with 20 subjects in each group, to further evaluate the safety, tolerance, PK and anti-tumor activity of paclitaxel micelle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel Micelles for Injection | Experimental | Drug: Paclitaxel Micelles for InjectionIn the First Period, Only three Participants in the first dose group were randomly assigned to 175 mg/m2 paclitaxel micelle for injection at a 1:1 rate.175 mg/m2, 260 mg/m2, 320 mg/m2, and 390 mg/m2 of paclitaxel micelle for Injection was intravenously administrated for three hours,three weeks constituted one course of treatment. |
| Paclitaxel Injection | Active comparator | Drug: Paclitaxel injectionthree Participants were randomly assigned to 175 mg/m2 paclitaxel Injection,175 mg/m2 of conventional Paclitaxel Injection was intravenously administrated for three hours, three weeks constituted one course of treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participants are required to meet all the criteria below in order to be included in the trial:
Key exclusion criteria (20 listed)
- Eligible participants must not meet any of the following exclusion criteria:
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 |
|---|---|---|
| Paclitaxel Micelles for InjectionPaclitaxel Micelles for Injection was intravenously administrated for three hours, three weeks constituted one course of treatment. | Drug | Paclitaxel Micelles for Injection |
| Paclitaxel injectionPaclitaxel Injection was intravenously administrated for three hours, three weeks constituted one course of treatment. | Drug | Paclitaxel Injection |
Primary outcome
Safety and tolerability of Paclitaxel Micelles for Injection in dose ascending and dose extension as measured by assessment of maximum tolerated dose (MTD) and dose limiting toxicity (DLT).
Time frame: 2 years
MTD was determined as the dose where more than 2 out of 6 subjects experienced DLT
The recommended dose for the phase II study
Time frame: 2 years
Determined as the recommended dose for a phase 2 study based on the adverse events and toxicities at each dose groups
13 secondary outcomes
Cmax of Paclitaxel Micelles for Injection
Time frame: Cycles 1(each cycle is 21 days) ,Day1 to Day4.
Tmax of Paclitaxel Micelles for Injection
Time frame: Cycles 1(each cycle is 21 days) ,Day1 to Day4.
AUC0-t of Paclitaxel Micelles for Injection
Time frame: Cycles 1(each cycle is 21 days), Day1 to Day4.
AUC0-inf of Paclitaxel Micelles for Injection
Time frame: Cycles 1(each cycle is 21 days) ,Day1 to Day4.
λz of Paclitaxel Micelles for Injection
Time frame: Cycles 1(each cycle is 21 days), Day1 to Day4.
t½ of Paclitaxel Micelles for Injection
Time frame: Cycles 1(each cycle is 21 days), Day1 to Day4.
CL of Paclitaxel Micelles for Injection
Time frame: Cycles 1(each cycle is 21 days), Day1 to Day4.
Vz of Paclitaxel Micelles for Injection
Time frame: Cycles 1(each cycle is 21 days), Day1 to Day4.
%AUCex of Paclitaxel Micelles for Injection
Time frame: Cycles 1(each cycle is 21 days), Day1 to Day4.
Objective response rate (ORR) of Paclitaxel Micelles
Time frame: Baseline to date of first documented progression or date of the patients drop out of the study, up to 24 months.
Disease Control Rate (DCR) of Paclitaxel Micelles
Time frame: Baseline to date of first documented progression or date of the patients drop out of the study, up to 24 months.
Progression-free survival (PFS) of Paclitaxel Micelles
Time frame: Baseline to date of first documented progression or date of the patients drop out of the study, up to 24 months.
Duration of remission (DOR) of Paclitaxel Micelles
Time frame: Baseline to date of first documented progression or date of the patients drop out of the study, up to 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- 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.
jian liu, master principal investigator
The First Affiliated Hospital,ZheJiang Univercity
xiaochen zhang, docter principal investigator
The First Affiliated Hospital,ZheJiang Univercity
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 Paclitaxel Micelles for Injection and Paclitaxel injection in people with Advanced Solid Tumors, run by First Affiliated Hospital of Zhejiang University 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 20 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 6 Aug 2025. 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 jian liu, master (+86-13958054006, lindaliu87@zju.edu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of Paclitaxel Micelles for Injection in dose ascending and dose extension as measured by assessment of maximum tolerated dose (MTD) and dose limiting toxicity (DLT). (time frame: 2 years). 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 6 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.