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Advanced Solid TumorsPhase 1NCT04811118

The Comparison of the Pharmacokinetics of Albumin-bound Docetaxel and Taxotere

A Phase 1 study testing Docetaxel for Injection (Albumin-bound) and Taxotere in people with Advanced Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a randomized, open-label, two-period, crossover trial to evaluate the pharmacokinetic profiles of albumin-bound docetaxel for intravenous infusion and Taxotere in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
Docetaxel for Injection (Albumin-bound) and Taxotere
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteChina
Study dates
18 May 2021to 31 Dec 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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18, ≤65 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, unacceptable or with other limitations 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；
  • Major organ function within 7 days prior to treatment meets the following criteria (no blood transfusion, EPO, G-CSF or other medical support within 14 days prior to study drug administration): ANC≥1.5×109/L，PLT≥100×109/L，Hb≥90g/L or≥5.6 mmol/L；Cr≤1.5×ULN and creatinine clearance rate≥50ml/min；TBIL≤1.0×ULN，AAG≥1.0×LLN，except for those with AST/ALT>1.5 × ULN and ALP>2.5× ULN;
  • Patients of childbearing potential must agree to use effective contraceptive measures (such as IUD, contraceptive pill or condom) during the period of the trial and for at least 6 months after completion of the study. Female patients must be negative on the serum pregnancy test within 7 days before enrollment, and must be nonlactating. Male patients refrains from donating sperm during the study period and for at least 6 months after completion of the study；
  • Signed informed consent form.

Who cannot join

  • Treatment failure of prior docetaxel or paclitaxel treatment (such as: patients who relapse within 6 months after last treatment);
  • 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 within 4 weeks of the first dose of the study drug；
  • Major surgery (excluding biopsy) or significant trauma within 4 weeks of the first dose of the study drug. Or have a surgical schedule during the study period.
  • Administration of glucocorticoids or other immunosuppressants within 14 days prior to the first dose of d the study drug.Local, ocular, intraarticular, intranasal, inhaled glucocorticoids, and a short-term use of glucocorticoids for preventive treatment is allowed；
  • Concomitant use of strong CYP3A4 inhibitors or inducers within 14 days of the first dose of the study drug；
Show all 18Show fewer
  • Allergic history to Taxanes or any excipients of the study drug (CTCAE 5.0 grade ≥ 3 grade)；
  • Adverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0 (except for the toxicity without safety risk judged by the investigator, such as hair loss)；
  • Central nervous system metastasis or meningeal metastasis with clinical symptoms, or other evidence shows that the patient's central nervous system metastasis or meningeal metastasis has not been controlled and not suitable for the study according to the judgment of the investigator；
  • History of autoimmune diseases, immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency, or organ transplant history；
  • Known Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or other active viral infection；
  • History of serious cardiovascular disease；
  • Uncontrollable effusion (eg. large amount of pleural effusion, ascites or pericardial effusion)；
  • Known alcohol or drug abuse；
  • Visual impairment such as cystoid macular edema；
  • History of neurological or psychiatric disorders；
  • Homozygous carriers of ABCB1-1236C>T（rs1128503）;
  • Not suitable for this study as determined by the investigator due to other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cangzhou Central Hospital

    Cangzhou

Other trials in China

About this study

Official title: A Randomized, Open-label, Two-period, Crossover Trial to Compare the Pharmacokinetic Profiles Between Albumin-bound Docetaxel and Taxotere in Patients With Advanced Solid Tumors

This is a randomized, open-label, two-period, crossover trial to evaluate the pharmacokinetic profiles of albumin-bound docetaxel for intravenous infusion and Taxotere in patients with advanced solid tumors.

Read the detailed description

The trial will be performed as a randomized, open-label, two-period crossover trial to compare the test drug (T, albumin-bound docetaxel) to the reference drug (R, Taxotere). Approximately 28 subjects will be randomized to the two treatment sequences (T-R or R-T) at the ratio of 1:1. Each enrolled subject will receive an intravenous infusion of the reference drug and the test drug in two treatment periods per the randomization schedule. The treatment periods will be separated by a washout period of 21 to 35 days. After completing two cycles of treatments, subjects may continue to receive the treatment used in the second cycle according to the responses (up to 1 year).

Being tested
Docetaxel for Injection (Albumin-bound), Taxotere

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Docetaxel for Injection (Albumin-bound)Drug

    Also called Docetaxel

    Docetaxel for Injection (Albumin-bound) by intravenous infusion

  • TaxotereDrug

    Also called Docetaxel

    Taxotere

Study groups in NCT04811118
Study groupRoleWhat they receive
Albumin-bound docetaxelExperimentalSubjects will receive albumin-bound docetaxel via intravenous infusion (IV) once every three weeks (a cycle), at the dose of 75mg/m2
Receives: Drug: Docetaxel for Injection (Albumin-bound)
TaxotereExperimentalSubjects will receive Taxotere via intravenous infusion once every three weeks (a cycle), at the dose of 75mg/m2.
Receives: Drug: Taxotere

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The pharmacokinetic parameters (free docetaxel and total docetaxel) : Cmax

    Peak Plasma Concentration (Cmax)

    Measured: At the end of Cycle 2 (each cycle is 21 days)

  2. The pharmacokinetic parameters (free docetaxel and total docetaxel) : AUC0-t、AUC0-∞

    Area under the plasma concentration versus time curve (AUC)

    Measured: At the end of Cycle 2 (each cycle is 21 days)

Secondary outcomes (5)

  1. 1.The occurrence and frequency of adverse events and serious adverse events

    1. The occurrence and frequency of adverse events and serious adverse events

    Measured: through study completion, up to 18 weeks

  2. 2. 1 Efficacy measures such as overall response rate (ORR)

    overall response rate (ORR)

    Measured: through study completion, up to 18 weeks

  3. 2. 2 Efficacy measures such as progression-free survival (PFS)

    progression-free survival (PFS)

    Measured: through study completion, up to 18 weeks

  4. 2.3 Efficacy measures such as disease control rate (DCR)

    disease control rate (DCR)

    Measured: through study completion, up to 18 weeks

  5. 2. 4 Efficacy measures such as duration of response (DOR).

    duration of response (DOR)

    Measured: through study completion, up to 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2021
  2. Study start18 May 2021
  3. Primary completion31 Oct 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

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
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04811118
Sponsor's protocol ID
HB1801-CSP-002
Status last verified
Jun 2021
First submitted
10 Mar 2021
Last updated
31 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Docetaxel for Injection (Albumin-bound) and Taxotere 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 8 inclusion and 18 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?

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?

The pharmacokinetic parameters (free docetaxel and total docetaxel) : Cmax (time frame: At the end of Cycle 2 (each cycle is 21 days)). 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?

On the ClinicalTrials.gov record for NCT04811118.

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.

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