Health Condition 1: Z854- Personal history of malignant neoplasm of genital organs
Conditions
Interventions
Intervention1: DOCEAQUALIP 20/80
(DOCETAXEL LIPID
SUSPENSION FOR
INJECTION 20/80 mg/vial of
Intas Pharmaceuticals Limited,
India: Dose: 75 mg/meter square
Duration of treatment: 210 days
Control Intervention1: NA: NA
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient willing and able to give informed consent to participate in the study. 2. Patient with confirmed metastatic castration resistant prostate cancer. 3. Measurable disease (minimum 1 measurable lesion) on either computed tomography scan or magnetic resonance imaging or positive bone scan with any level of serum prostate specific antigen (PSA) greater than or equal to 5 ng/ml 4. No use of antiandrogens for at least 6 weeks (except LHRH agonist) 5. Patient must have an adequate bone marrow, renal, cardiac and hepatic function 6. Patients without bilateral orchidectomy must be receiving LHRH agonist therapy for at least 3 months before screening. These patients should be receiving treatment with luteinizing hormone releasing hormone agonist throughout the study period. (LHRH agonist may be taken as per investigator discretion) 7. At least four weeks elapsed between prior surgery or prior radiotherapy and initiation of docetaxel therapy. 8. Rdiograph documented evidence of soft tissue or bony metastatic disease. 9. Patient should be able to comply with study procedures in the opinion of the investigator. 10. Patient with a performance status of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) 11. Patient with Life expectancy more than 7 months 12. Patient or his partner must agree to use effective measures of contraception during the study. Moreover patients should agree to use effective contraceptive method at least for 6 months after the end of treatment.
Exclusion criteria
Exclusion criteria: 1.Patient with the history of hypersensitivity reactions to Taxanes or any other component of formulation. 2. Chronic treatment with immunosuppressive agent (except prednisone) or patient with severely immunocompromised state. 3. Patients with an active, severe infection (e.g., tuberculosis, sepsis and opportunistic infections etc.). 4. Major surgery within 4 weeks prior to dosing or planned major surgery. 5. Prior chemotherapy for prostate cancer 6. Patient with known CNS lesions (brain metastasis or carcinomatous meningitis). 7. Any history or presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease or any other condition which in the opinion of the investigator could jeopardize the safety of the subject or the validity of the study results. 8. Patient has "currently active" second malignancy, other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy if they have completed therapy greater than 5 years previously and have no known evidence of residual or recurrent disease. 9. The receipt of an investigational medicinal product or participation in other drug research study within a period of 30 days prior to the first dose of investigational medicinal Product for the current study. 10. Patients with hepatitis B or hepatitis C infection or HIV infection. 11. Pre-existing motor or sensory neurotoxicity of a severity greater than or equal to grade 2 as defined by NCI CTCAE 4.03 criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the efficacy of DOCEAQUALIP 20/80 (Docetaxel Lipid Suspension for Injection) in the patients with metastatic castration resistant prostate cancerTimepoint: Visit 1, 8, 14, 22 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of DOCEAQUALIP in patientsTimepoint: Visit 1 to visit 25 | — |
Countries
India
Contacts
Public ContactMr Prashant Modi
Lambda Therapeutic Research Ltd
Outcome results
None listed