CTRI/2021/04/033049已完成未知
A multicenter, open label, randomized, balanced, two treatment, two period, twosequence, crossover, single dose, bioequivalence study of BH009 [DocetaxelInjection 80 mg/4 mL (20 mg/mL), developed by: Zhuhai Beihai Biotech Co.,Ltd.] against Winthrop (docetaxel) injection 20 mg/mL (an authorized generic drugof Taxotere�®; manufactured by: Sanofi-Aventis Deutschland GmbH) in patientswith solid tumors requiring treatment with docetaxel monotherapy (Dose: 75mg/m2).
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •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
排除标准
- •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.
研究者
相似试验
进行中（未招募）
不适用
To compare the blood levels of liposomal Doxorubicin (Sun Pharma) with Caelyx (Pegylated Liposomal doxorubicin) of Janssen-Cilag International NV in patients with ovary and breast cancerCTRI/2018/10/016089Sun Pharmaceutical Industries Ltd Vadodara India59
已完成
不适用
A bioequivalence study of Capecitabine tablets in adult human cancer patients.CTRI/2015/02/005514Shilpa Medicare Limited54
进行中（未招募）
不适用
To compare the blood levels of liposomal Doxorubicin (Sun Pharma) with Doxil® (PegylatedLiposomal doxorubicin)) in patients with platinum resistant recurrence or relapse mullerian carcinoma (epithelial ovarian cancer, primary fallopian tube cancer, peritoneal cancer)CTRI/2022/01/039082Sun Pharmaceutical Industries Limited
已完成
不适用
This is comparative study for the Imatinib Mesylate 400mg tablets with Imatinib Mesylate 400mg tablets of ( Gleevec)Novartis Pharmaceuticals Corporation, East Hanover, New Jersey in patients with Chronic Myeloid Leukemia and/or Gastrointestinal Stromal Tumor under fed steady-state condition.CTRI/2013/02/003435Onco Therapies Limited A subsidiary of Strides Arcolab Ltd32
已完成
不适用
This is comparative study for the Imatinib Mesylate 400mg tablets with Imatinib Mesylate 400mg tablets of (GLIVEC®)Novartis Europharm Limited, United Kingdom in patients with Chronic Myeloid Leukemia and/or Gastrointestinal Stromal Tumor under fed steady-state condition.CTRI/2013/04/003546Onco Therapies Limited which is a subsidiary of Strides Arcolab Ltd32