Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Docetaxel Injection 80 mg/4 mL, developed by: Zhuhai Beihai Biotech Co. Ltd.: Period I (Day 1): Patients will receive 75 mg/m2 dose of docetaxel injection for intravenous infusion (eith
manufactured by: Sanofi-Aventis Deutschland GmbH): Period I (Day 1): Patients will receive 75 mg/m2 dose of docetaxel injection for intravenous infusion (either test or reference product) on the first
Sponsors
Zhuhai Beihai Biotech Co Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients meeting all of the following criteria will be considered for enrollment in the study. 1. Patients of either gender, more than or equal 18 years of age. 2. 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. 3. 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 taxotereÃ?®), 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) 4. ECOG performance status 0 or 1 and Life expectancy ââ?°Â¥3 months (as per the Investigatorââ?¬•s discretion). 5. Adequate Hematopoietic, Renal and Liver function defined as the following: Body system Parameters Bone marrow function Bone marrow function ANC more than or equal to 1500/mm3 Platelet count more than or equal to 100,000/mm3 Haemoglobin more than 9.0 g/dl Hepatic function ALT/AST less than or equal 1.5 Ã?â?? ULN Alkaline phosphatase less than or equal 2.5 Ã?â?? ULN Total Bilirubin less than or equal ULN Renal function Serum creatinine less than or equal 1.5 x ULN 6. Prothrombin time, international normalized ratio or activated partial thromboplastin time less than 1.5 Ã?â?? ULN; Use of full dose anticoagulants is permitted. These laboratories should be maintained within the therapeutic range and closely monitored by the Investigator. 7. 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. 8. 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. 9. In case of female patient, the serum pregnancy test at screening visit and urine pregnancy test at baseline must be negative. 10. 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 dr
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study, if they meet any of the following criteria: 1. Hypersensitivity or idiosyncratic reaction to docetaxel, its excipients, and/or related substances including polysorbate 80, paclitaxel, alcohol, dexamethasone and Antiemetic (Granisetron or Ondansetron). 2. 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. 3. Average corrected QT (QTc) interval by Fredericaââ?¬•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. 4. Patients with an active infection (e.g. tuberculosis, sepsis and opportunistic infections). 5. Patients with severe pleural effusion (volume involving > 40% of the hemithorax on CT scan chest) or gross ascites ( >800 mL of ascitic fluid)3,4. 6. Peripheral neuropathy ââ?°Â¥grade 2 (as per CTCAE 5.04 criteria). 7. A positive hepatitis screen including hepatitis B surface antigen and HCV antibodies. 8. Patients with HIV infection. 9. Patients with known brain metastasis or those showing neurologic symptoms due to brain metastasis. 10. Recent or clinically significant history of drug or alcohol abuse. 11. Patients require concomitant treatment with potent Cytochrome P450 3A4 inhibitors, inducers or substrates. 12. 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. 13. Major surgery within 4 weeks prior to study entry; minor surgery within 2 weeks prior to study entry. 14. 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. 15. 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. 16. Pregnant or Breast feeding female. 17. 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. 18. Abnormal baseline laboratory/physical findings considered to be clinical significant by the investigator. 19. Patients with any significant history of non-compliance or inability to reliably grant informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate pharmacokinetic and establish the bioequivalence of the test product Docetaxel Injection 80 mg/4 mL) of Zhuhai Beihai Biotech Co., Ltd., China relative to that of reference product Winthrop (docetaxel) injection 20 mg/mL (an authorized generic drug of TaxotereÃ?®), manufactured by: Sanofi Aventis Deutschland GmbH in patients with solid tumors requiring treatment with docetaxel monotherapy at a dose of 75 mg/m2Timepoint: Total 17 blood samples for PK assessment will be collected on Day 1 and Day 21.The pre-infusion blood sample of 06 ml will be collected within 5 minutes prior to start of infusion. The blood samples of 06 ml each will be drawn at 0.500(30 min), 0.667(40 min), 0.833(50 min) during infusion, 1 hr (immediately at actual end of infusion), 0.083 (5 min), 0.167 (10 min), 0.333 (20 min), 0.500 (30 min),1.000, 2.000, 3.000, 6.000, 8.000, 12.000, 24.000 and 48.000hrs post infusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability profile of the study formulations.Timepoint: Physical examination,vital signs,ECG,laboratory evaluations and adverse event monitored at Baseline at screening and 24 hrs prior dosing and 48 hrs post dose. Day 7 safety assessment. On Day 21 at 24 hrs prior dosing and 48 hrs post dose. Day 29 at end of the study vist. For AE will be followed for 30 days or until resolution/ stabilization after last IMP administration. | — |
Countries
India
Contacts
Public ContactDr Ravi Alamchandani
Veeda Clinical Research Pvt, Ltd.
Outcome results
None listed