Advanced Solid TumorsPhase 1NCT04471675
Evaluation of the Safety and Efficacy of Albumin-bound Docetaxel
A Phase 1 study testing Albumin-bound docetaxel in people with Advanced Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This trial is an open-label, single-center, dose-escalation and cohort-expansion Phase I clinical study in patients with advanced solid tumors. The aim of this study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of albumin-bound formulation of docetaxel for… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- Albumin-bound docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 2 Dec 2020to 15 Dec 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18, ≤75 years, no gender limitation；
- Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors, for which standard therapy either does not exist or has proven to be ineffective, intolerable or unacceptable for the patient；
- At least one measurable lesion as per RECIST version 1.1；
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1；
- Life expectancy ≥3 months；
- Adequate bone marrow, cardiac, liver and renal function；
Who cannot join
- Chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor treatment within 4 weeks of the first dose of the study drug, 6 weeks for mitomycin C or nitrosoureas, 2 weeks (or 5 half-lives whichever is longer) for using fluorouracil or small molecule targeted drugs, 2 weeks for using traditional Chinese medicine with anti-tumor indications；
- Currently enrolled in any other clinical study, or administration of other investigational agents w
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Bi Feng
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Albumin-bound Formulation of Docetaxel for Intravenous Infusion in Patients With Advanced Solid Tumors: A Phase 1, Single-center, Open-label, Dose-escalation Study
This trial is an open-label, single-center, dose-escalation and cohort-expansion Phase I clinical study in patients with advanced solid tumors. The aim of this study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of albumin-bound formulation of docetaxel for intravenous infusion in patients with advanced solid tumors.
Read the detailed description
This study was conducted in two stages. The first stage (Stage I) is a dose-escalation study. A classic 3+3 design will be used to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Patients with advanced solid tumors will be assigned to receive sequentially higher doses of albumin-bound formulation of docetaxel once every three weeks (a Cycle) by intravenous infusion, starting at a dose of 50mg/m2. Patients will receive the albumin-bound formulation of docetaxel
- Conditions
- Advanced Solid Tumors
- Being tested
- Albumin-bound docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin-bound docetaxelDrug
Albumin-bound docetaxel by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: solid tumors | Experimental | Albumin-bound docetaxel by intravenous infusion.Patients receive albumin-bound docetaxel once every three weeks (a Cycle), starting at a dose of 50mg/m2. Receives: Drug: Albumin-bound docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who experienced AE during cycle1.
AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.
Measured: 21 days.
Number of participants who experienced DLT during cycle1.
A DLT was graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.02 and defined as any of the following: grade 3 or 4 non-hematologic adverse events unless they were not optimally treated with supportive care; grade 3 or 4 asymptomatic laboratory abnormal values lasting >7 days; prolonged grade 2 toxicity (lasting more than 2 weeks) leading to treatment interruption and/or dose reduction; pancytopenia with a hypocellular bone marrow and no marrow blasts lasting ≥6 weeks (AL participants); grade 3 neutropenia with fever or infection (OHM participants); grade 3 thrombocytopenia with bleeding (OHM participants); or grade 4 neutropenia or thrombocytopenia, regardless of symptoms and lasting ≥3 days (OHM participants).
Measured: 21 days.
Classic 3+3 design to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D)
The maximum tolerated dose (MTD) (if available) and recommended Phase 2 dose (RP2D) of Albumin-bound Docetaxel.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (10)
Area under the concentration-time curve of Albumin-bound Docetaxel from time 0 to last (AUC 0-∞)
The pharmacokinetic parameters AUC0-last of Albumin-bound Docetaxel.
Measured: 21 days.
Area under the concentration-time curve of Albumin-bound Docetaxel from time 0 to infinity (AUC 0-∞)
The pharmacokinetic parameters AUC0-∞ of Albumin-bound Docetaxel.
Measured: 21 days.
Observed maximum concentration (Cmax )of Albumin-bound Docetaxel
The pharmacokinetic parameters Cmax of Albumin-bound Docetaxel.
Measured: 21 days.
Time to maximum concentration (Tmax) of Albumin-bound Docetaxel
The pharmacokinetic parameters Tmax of Albumin-bound Docetaxel.
Measured: 21 days.
Apparent terminal Half-Life (t1/2) of Albumin-bound Docetaxel
The pharmacokinetic parameters t½ of Albumin-bound Docetaxel.
Measured: 21 days.
Apparent total body clearance (CL/F) of Albumin-bound Docetaxel
The pharmacokinetic parameters CL/F of Albumin-bound Docetaxel.
Measured: 21 days.
Objective response rate (ORR)
Efficacy measures overall response rate (ORR) of Albumin-bound Docetaxel.
Measured: Through study completion, an average of 1 year.
Progression free survival (PFS)
Efficacy measures progression-free survival (PFS) of Albumin-bound Docetaxel.
Measured: Through study completion, an average of 1 year.
Disease control rate (DCR)
Efficacy measures disease control rate (DCR) of Albumin-bound Docetaxel.
Measured: Through study completion, an average of 1 year.
Duration of response (DOR)
Efficacy measures duration of response (DOR) of Albumin-bound Docetaxel.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start2 Dec 2020
- Primary completion15 Dec 2022 (estimated)
- Study completion15 Dec 2023 (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 CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471675
- Sponsor's protocol ID
- HB1801-CSP-001
- Status last verified
- Jan 2022
- First submitted
- 7 Jul 2020
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Albumin-bound Formulation of Docetaxel for Intravenous Infusion in Patients With Advanced Solid Tumors: A Phase 1, Single-center, Open-label, Dose-escalation Study
- ClinicalTrials.gov ID
- NCT04471675
- Acronym / sponsor ID
- HB1801-CSP-001
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 15 Jul 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 trial is an open-label, single-center, dose-escalation and cohort-expansion Phase I clinical study in patients with advanced solid tumors. The aim of this study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of albumin-bound formulation of docetaxel for intravenous infusion in patients with advanced solid tumors.
Detailed description
This study was conducted in two stages. The first stage (Stage I) is a dose-escalation study. A classic 3+3 design will be used to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Patients with advanced solid tumors will be assigned to receive sequentially higher doses of albumin-bound formulation of docetaxel once every three weeks (a Cycle) by intravenous infusion, starting at a dose of 50mg/m2. Patients will receive the albumin-bound formulation of docetaxel
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: solid tumors | Experimental | Drug: Albumin-bound docetaxelAlbumin-bound docetaxel by intravenous infusion.Patients receive albumin-bound docetaxel once every three weeks (a Cycle), starting at a dose of 50mg/m2. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18, ≤75 years, no gender limitation；
- Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors, for which standard therapy either does not exist or has proven to be ineffective, intolerable or unacceptable for the patient；
- At least one measurable lesion as per RECIST version 1.1；
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1；
- Life expectancy ≥3 months；
Key exclusion criteria (2 listed)
- Chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor treatment within 4 weeks of the first dose of the study drug, 6 weeks for mitomycin C or nitrosoureas, 2 weeks (or 5 half-lives whichever is longer) for using fluorouracil or small molecule targeted drugs, 2 weeks for using traditional Chinese medicine with anti-tumor indications；
- Currently enrolled in any other clinical study, or administration of other investigational agents w
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 |
|---|---|---|
| Albumin-bound docetaxelAlbumin-bound docetaxel by intravenous infusion. | Drug | Experimental: solid tumors |
Primary outcome
Number of participants who experienced AE during cycle1.
Time frame: 21 days.
AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.
Number of participants who experienced DLT during cycle1.
Time frame: 21 days.
A DLT was graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.02 and defined as any of the following: grade 3 or 4 non-hematologic adverse events unless they were not optimally treated with supportive care; grade 3 or 4 asymptomatic laboratory abnormal values lasting >7 days; prolonged grade 2 toxicity (lasting more than 2 weeks) leading to treatment interruption and/or dose reduction; pancytopenia with a hypocellular bone marrow and no marrow blasts lasting ≥6 weeks (AL participants); grade 3 neutropenia with fever or infection (OHM participants); grade 3 thrombocytopenia with bleeding (OHM participants); or grade 4 neutropenia or thrombocytopenia, regardless of symptoms and lasting ≥3 days (OHM participants).
Classic 3+3 design to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D)
Time frame: Through study completion, an average of 1 year.
The maximum tolerated dose (MTD) (if available) and recommended Phase 2 dose (RP2D) of Albumin-bound Docetaxel.
10 secondary outcomes
Area under the concentration-time curve of Albumin-bound Docetaxel from time 0 to last (AUC 0-∞)
Time frame: 21 days.
Area under the concentration-time curve of Albumin-bound Docetaxel from time 0 to infinity (AUC 0-∞)
Time frame: 21 days.
Observed maximum concentration (Cmax )of Albumin-bound Docetaxel
Time frame: 21 days.
Time to maximum concentration (Tmax) of Albumin-bound Docetaxel
Time frame: 21 days.
Apparent terminal Half-Life (t1/2) of Albumin-bound Docetaxel
Time frame: 21 days.
Apparent total body clearance (CL/F) of Albumin-bound Docetaxel
Time frame: 21 days.
Objective response rate (ORR)
Time frame: Through study completion, an average of 1 year.
Progression free survival (PFS)
Time frame: Through study completion, an average of 1 year.
Disease control rate (DCR)
Time frame: Through study completion, an average of 1 year.
Duration of response (DOR)
Time frame: Through study completion, an average of 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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.
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 Albumin-bound docetaxel in people with Advanced Solid Tumors, run by CSPC ZhongQi 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 6 inclusion and 2 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 31 Jan 2022. 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 Bi Feng, Chief doctor (028-85423203, bifenggcp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who experienced AE during cycle1. (time frame: 21 days.). 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 31 Jan 2022.