DocetaxelPhase 3NCT04889599
A Bioequivalence Study of Docetaxel Injection in Patients With Solid Tumours
A Phase 3 study testing BH009 (Docetaxel injection) and Docetaxel injection in people with Docetaxel and Solid Tumours, run by Zhuhai Beihai Biotech Co., Ltd at 3 sites in India.
Trial summary
The study will be conducted in patients with solid tumors for whom single-agent docetaxel, in the dose of 75 mg/m2, is a suitable treatment option. Each patient, meeting all the inclusion criteria and none of the exclusion criteria, will receive test or reference product in a cross over manner based on randomization… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Docetaxel, Solid Tumours, Bioequivalence
- What is being tested?
- BH009 (Docetaxel injection) and Docetaxel injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesIndia
- Study dates
- 29 Apr 2021to 24 Sep 2021
- Phase
- Phase 3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients meeting all of the following criteria will be considered for enrollment in the study.
- Patients of either gender, ≥18 years of age.
- Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
- Histologically or cytologically confirmed advanced solid tumors who are scheduled to receive treatment with single-agent docetaxel, in the dose of 75 mg/m2 or those whose are already receiving single-agent docetaxel (taxotere® or an approved generic drug of taxotere®), in the dose of 75 mg/m2 and are scheduled to two more cycles, in the same dose, as per the actual treatment plan. Note: Metastatic castration-resistant prostate cancer will not be considered for the study as the patients are required to receive prednisone along with docetaxel and the regime of dexamethasone (CYP 3A4 inducer is different from that in other indications)
- ECOG performance status 0 or 1 and Life expectancy ≥3 months (as per the Investigator's discretion).
- Adequate Hematopoietic, Renal and Liver function defined as the following:
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- Bone marrow function :ANC ≥1500/mm3, Platelet count ≥100,000/mm3, Haemoglobin > 9.0 g/dl Hepatic function:ALT/AST ≤ 1.5 × ULN, Alkaline phosphatase ≤ 2.5 × ULN ,Total Bilirubin ≤ ULN Renal function:Serum creatinine ≤1.5 x ULN
- Prothrombin time, international normalized ratio or activated partial thromboplastin time <1.5 × ULN; Use of full dose anticoagulants is permitted. These laboratories should be maintained within the therapeutic range and closely monitored by the Investigator.
- Recovery, to Grade 0-1 (as per CTCAE 5.04 criteria), from adverse events related to prior anticancer therapy except alopecia and endocrinopathies controlled with hormone replacement therapy.
- Prior chemotherapy (except ongoing taxotere or an approved generic of taxotere, in which last dose must have been received at least 21 days prior to cycle 1 of the study), immunotherapy and radiation therapy must be completed at least 30 days prior to randomization (42 days for mitomycin C or nitrosoureas). Completion of palliative radiotherapy to a single disease site must be completed at least 14 days prior to randomization.
- In case of female patient, the serum pregnancy test at screening visit and urine pregnancy test at baseline must be negative.
- Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to Study drug administration] sexual partner) for at least 1 month prior to study drug administration, during study and up to 6 month after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.
- In case of male patients: either partner or patient must use an effective method of avoiding pregnancy for at least 1 month prior to study drug administration, during study and up to 3 month after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.
Who cannot join
- Patients will be excluded from the study, if they meet any of the following criteria:
- Hypersensitivity or idiosyncratic reaction to docetaxel, its excipients, and/or related substances including polysorbate 80, paclitaxel, alcohol, dexamethasone and Antiemetic (Granisetron or Ondansetron).
- Severe cardiovascular disease, including CVA, TIA, myocardial infarction, or unstable angina within 6 months of study entry; NYHA class III or IV heart failure within 6 months of study entry; uncontrolled arrhythmia within 6 months of study entry.
- Average corrected QT (QTc) interval by Frederica's formula (QTcF) on triplicate ECGs at screening > 470 msec (females) or > 450 msec (males); or on concomitant medications that would prolong the QT interval; or have family history of long QT syndrome.
- Patients with an active infection (e.g. tuberculosis, sepsis and opportunistic infections).
- Patients with severe pleural effusion (volume involving > 40% of the hemithorax on CT scan chest) or gross ascites (>800ml of ascitic fluid)3,4.
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- Peripheral neuropathy ≥grade 2 (as per CTCAE 5.04 criteria).
- A positive hepatitis screen including hepatitis B surface antigen and HCV antibodies.
- Patients with HIV infection.
- Patients with known brain metastasis or those showing neurologic symptoms due to brain metastasis.
- Recent or clinically significant history of drug or alcohol abuse.
- Patients require concomitant treatment with potent Cytochrome P450 3A4 inhibitors, inducers or substrates.
- Use of any Cytochrome P450 3A4 inducers, inhibitors, or substrates that may alter docetaxel metabolism (e.g. dronedarone, epirubicin, sorafenib, CNS depressants) within 14 days before randomization.
- Major surgery within 4 weeks prior to study entry; minor surgery within 2 weeks prior to study entry.
- Patients found positive on urine scan for drugs of abuse and/or breath test for alcohol consumption at screening or baseline. Note: Benzodiazepines and /or opioids given in therapeutic doses under the observation of physician for management of insomnia / anxiety / pain, etc., will be allowed, provided that there is no drug-drug interaction with the study drug and an approval from the Veeda medical monitor is taken.
- The receipt of an investigational medicinal product or participation in other drug research study within a period of 30 days (or 5 half-lives, whichever is longer) prior to the first dose of investigational medicinal product for the current study.
- Pregnant or Breast feeding female.
- Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
- Abnormal baseline laboratory / physical findings considered to be clinical significant by the investigator.
- Patients with any significant history of non-compliance or inability to reliably grant informed consent.
Trial locations and contacts
3 sites in 1 country.
India3 sites
HCG City Cancer center
Āndra
Nirmal Hospital Pvt. Ltd
Gujrāt
HCG Manavata Cancer Centre
Mahara
About this study
Official title: An Open Label, Two Treatment, Two Period, Two Sequence,Crossover, Bioequivalence Study of BH009 Against Winthrop (Docetaxel) Injection in Patients With Solid Tumors
The study will be conducted in patients with solid tumors for whom single-agent docetaxel, in the dose of 75 mg/m2, is a suitable treatment option. Each patient, meeting all the inclusion criteria and none of the exclusion criteria, will receive test or reference product in a cross over manner based on randomization schedule. A balance between T-R and R-T randomization sequence will be ensured using statistical techniques. Blood samples for PK assessment will be collected prior to and after start of intravenous infusion on Day 1 (Period I), Day 22 (Period II)
Read the detailed description
46 patients will be enrolled in the study.
The dosing schedule will be as follows:
Period I (Day 1): Patients will receive 75 mg/m2 dose of docetaxel injection for infusion (either test or reference product) on the first day of the chemotherapy cycle.
Period II (Day 22): Patients will be crossover to another treatment arm to receive 75 mg/m2 dose of docetaxel injection for infusion (either test or reference product depending of crossover sequence) on the first day of the next chemotherapy cycle.
A total of 17 blood samples for PK assessment will be collected during each period.
The pre-infusion blood sample of 06 mL (0.000 hr) will be collected within 5 minutes prior to start of infusion.
On Day 1 (Period I) and Day 22# (Period II):
The blood samples of 06 mL each will be drawn at 0.500 (30 minutes), 0.667 (40 minutes) and 0.833 (50 minutes) during infusion, 1.000 hour* (immediately at the actual end of infusion), and at 0.083 (5 minutes), 0.167 (10 minutes), 0.333 (20 minutes), 0.500 (30 minutes), 1.000, 2.000, 3.000, 6.000, 8.000, 12.000, 24.000 and 48.000 hours after the end of the docetaxel infusion.
Employing the estimated concentration time profiles of Unbound Docetaxel \& Total Docetaxel following variables will be calculated:
Primary variables: Cmax, AUC0-t and AUC0-∞
Secondary variable: Tmax, t1/2, Kel, Vd, CL and AUC_%Extrap_obs
Criteria for evaluation:
For Unbound Docetaxel \& Total Docetaxel, based on the statistical results of 90% confidence intervals for the geometric least square mean ratio (T/R) for the pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞, conclusions will be drawn whether test formulation is bioequivalent to reference formulation. Acceptance range for bioequivalence is 80.00% - 125.00% for 90% confidence intervals of the geometric least square means ratio (T/R) for Cmax, AUC0-t and AUC0-∞.
- Conditions
- Docetaxel, Solid Tumours, Bioequivalence
- Being tested
- BH009 (Docetaxel injection), Docetaxel injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BH009 (Docetaxel injection)Drug
Also called BH009
75mg/m2
Docetaxel injectionDrug
Also called Winthrop (Docetaxel) Injection
75mg/m2
| Study group | Role | What they receive |
|---|---|---|
| BH009 (Docetaxel Injection) | Experimental | Patients will receive single dose BH009 75 mg/m2, as a 1-hour IV infusion. Receives: Drug: BH009 (Docetaxel injection) |
| Docetaxel Injection | Active comparator | Patients will receive single dose Docetaxel Injection 75 mg/m2, as a 1-hour IV infusion. Receives: Drug: Docetaxel injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of docetaxel injection
Peak Plasma Concentration
Measured: On Day 1 (Period I) and Day 24 (Period II)
AUC of docetaxel injection
Area under the plasma concentration versus time curve
Measured: On Day 1 (Period I) and Day 24 (Period II)
Secondary outcomes (1)
To evaluate of safety and tolerability of BH009
Adverse event assessments included laboratory test values, patient reports, and investigator observations.
Number of participants and order of severity with treatment-related adverse events as assessed by CTCAE 5.04.
Measured: From the Period I Day 1 to 7 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start29 Apr 2021
- Primary completion17 Sep 2021
- Study completion24 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DocetaxelStudies 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhuhai Beihai Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gopichand M, Ph. D., Principal investigator, HCG City Cancer center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889599
- Sponsor's protocol ID
- 20-VIN-0225
- Status last verified
- May 2021
- First submitted
- 25 Apr 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho EK, Park JY, Lee KH, Song HS, Min YJ, Kim YH, Kang JH. Open-label, randomized, single-dose, crossover study to evaluate the pharmacokinetics and safety differences between two docetaxel products, CKD-810 and Taxotere injection, in patients with advanced solid cancer. Cancer Chemother Pharmacol. 2014 Jan;73(1):9-16. doi: 10.1007/s00280-013-2264-0. Epub 2013 Dec 12.
PubMed 24337589
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Two Treatment, Two Period, Two Sequence,Crossover, Bioequivalence Study of BH009 Against Winthrop (Docetaxel) Injection in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT04889599
- Acronym / sponsor ID
- 20-VIN-0225
- Conditions
- Docetaxel, Solid Tumours, Bioequivalence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Zhuhai Beihai Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 17 Sep 2021 (actual)
- Study completion
- 24 Sep 2021 (actual)
- First posted
- 17 May 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.
The study will be conducted in patients with solid tumors for whom single-agent docetaxel, in the dose of 75 mg/m2, is a suitable treatment option. Each patient, meeting all the inclusion criteria and none of the exclusion criteria, will receive test or reference product in a cross over manner based on randomization schedule. A balance between T-R and R-T randomization sequence will be ensured using statistical techniques. Blood samples for PK assessment will be collected prior to and after start of intravenous infusion on Day 1 (Period I), Day 22 (Period II)
Detailed description
46 patients will be enrolled in the study.
The dosing schedule will be as follows:
Period I (Day 1): Patients will receive 75 mg/m2 dose of docetaxel injection for infusion (either test or reference product) on the first day of the chemotherapy cycle.
Period II (Day 22): Patients will be crossover to another treatment arm to receive 75 mg/m2 dose of docetaxel injection for infusion (either test or reference product depending of crossover sequence) on the first day of the next chemotherapy cycle.
A total of 17 blood samples for PK assessment will be collected during each period.
The pre-infusion blood sample of 06 mL (0.000 hr) will be collected within 5 minutes prior to start of infusion.
On Day 1 (Period I) and Day 22# (Period II):
The blood samples of 06 mL each will be drawn at 0.500 (30 minutes), 0.667 (40 minutes) and 0.833 (50 minutes) during infusion, 1.000 hour* (immediately at the actual end of infusion), and at 0.083 (5 minutes), 0.167 (10 minutes), 0.333 (20 minutes), 0.500 (30 minutes), 1.000, 2.000, 3.000, 6.000, 8.000, 12.000, 24.000 and 48.000 hours after the end of the docetaxel infusion.
Employing the estimated concentration time profiles of Unbound Docetaxel \& Total Docetaxel following variables will be calculated:
Primary variables: Cmax, AUC0-t and AUC0-∞
Secondary variable: Tmax, t1/2, Kel, Vd, CL and AUC_%Extrap_obs
Criteria for evaluation:
For Unbound Docetaxel \& Total Docetaxel, based on the statistical results of 90% confidence intervals for the geometric least square mean ratio (T/R) for the pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞, conclusions will be drawn whether test formulation is bioequivalent to reference formulation. Acceptance range for bioequivalence is 80.00% - 125.00% for 90% confidence intervals of the geometric least square means ratio (T/R) for Cmax, AUC0-t and AUC0-∞.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BH009 (Docetaxel Injection) | Experimental | Drug: BH009 (Docetaxel injection)Patients will receive single dose BH009 75 mg/m2, as a 1-hour IV infusion. |
| Docetaxel Injection | Active comparator | Drug: Docetaxel injectionPatients will receive single dose Docetaxel Injection 75 mg/m2, as a 1-hour IV infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients meeting all of the following criteria will be considered for enrollment in the study.
- Patients of either gender, ≥18 years of age.
- Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
- Histologically or cytologically confirmed advanced solid tumors who are scheduled to receive treatment with single-agent docetaxel, in the dose of 75 mg/m2 or those whose are already receiving single-agent docetaxel (taxotere® or an approved generic drug of taxotere®), in the dose of 75 mg/m2 and are scheduled to two more cycles, in the same dose, as per the actual treatment plan. Note: Metastatic castration-resistant prostate cancer will not be considered for the study as the patients are required to receive prednisone along with docetaxel and the regime of dexamethasone (CYP 3A4 inducer is different from that in other indications)
- ECOG performance status 0 or 1 and Life expectancy ≥3 months (as per the Investigator's discretion).
Key exclusion criteria (20 listed)
- Hypersensitivity or idiosyncratic reaction to docetaxel, its excipients, and/or related substances including polysorbate 80, paclitaxel, alcohol, dexamethasone and Antiemetic (Granisetron or Ondansetron).
- Severe cardiovascular disease, including CVA, TIA, myocardial infarction, or unstable angina within 6 months of study entry; NYHA class III or IV heart failure within 6 months of study entry; uncontrolled arrhythmia within 6 months of study entry.
- Average corrected QT (QTc) interval by Frederica's formula (QTcF) on triplicate ECGs at screening > 470 msec (females) or > 450 msec (males); or on concomitant medications that would prolong the QT interval; or have family history of long QT syndrome.
- Patients with an active infection (e.g. tuberculosis, sepsis and opportunistic infections).
- Patients with severe pleural effusion (volume involving > 40% of the hemithorax on CT scan chest) or gross ascites (>800ml of ascitic fluid)3,4.
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 |
|---|---|---|
| BH009 (Docetaxel injection)Also: BH00975mg/m2 | Drug | BH009 (Docetaxel Injection) |
| Docetaxel injectionAlso: Winthrop (Docetaxel) Injection75mg/m2 | Drug | Docetaxel Injection |
Primary outcome
Cmax of docetaxel injection
Time frame: On Day 1 (Period I) and Day 24 (Period II)
Peak Plasma Concentration
AUC of docetaxel injection
Time frame: On Day 1 (Period I) and Day 24 (Period II)
Area under the plasma concentration versus time curve
1 secondary outcome
To evaluate of safety and tolerability of BH009
Time frame: From the Period I Day 1 to 7 days after the last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Background: PubMed 24337589Cho EK, Park JY, Lee KH, Song HS, Min YJ, Kim YH, Kang JH. Open-label, randomized, single-dose, crossover study to evaluate the pharmacokinetics and safety differences between two docetaxel products, CKD-810 and Taxotere injection, in patients with advanced solid cancer. Cancer Chemother Pharmacol. 2014 Jan;73(1):9-16. doi: 10.1007/s00280-013-2264-0. Epub 2013 Dec 12.
- Cancer Chemother Pharmacol. 2014 Jan;73(1):9-16. doi: 10.1007/s00280-013-2264-0. Epub 2013 Dec 12.Link provided by the sponsor.
- 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.
Gopichand M, Ph. D. principal investigator
HCG City Cancer center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BH009 (Docetaxel injection) and Docetaxel injection in people with Docetaxel and Solid Tumours, run by Zhuhai Beihai Biotech Co., Ltd at 3 sites in India.
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: finished, as of the sponsor's last update on 11 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 3 sites in India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cmax of docetaxel injection (time frame: On Day 1 (Period I) and Day 24 (Period II)). 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 NCT04889599, which also lists 1 linked publication.
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 11 Jan 2022; AzTrials last refreshed its copy on 7 Nov 2026.