Health Condition 1: C801- Malignant (primary) neoplasm, unspecified
Conditions
Interventions
Intervention1: Docetaxel lipid suspension: Patients will be administered Docetaxel Injection concentrate (either Reference product
or Test product) (75 mg/m2), by IV
Control Intervention1: TAXOTERE®
Sponsors
Intas Pharmaceuticals Limited India
Eligibility
Inclusion criteria
Inclusion criteria: 1.The patient must have given written, personally signed and dated, informed consent to participate in the study before initiating any study related procedures. 2. Male and Female ≥18 years and 3. Must have histopathologically /cytologically confirmed following primary tumors: Breast cancer, Head and neck, Lung, Melanoma, or Prostate for which docetaxel is a viable treatment option. 4.Able to comply with study requirement in opinion of Principal Investigator.
Exclusion criteria
Exclusion criteria: 1.Patient having hypersensitivity to Docetaxel injection 2. Intolerance to any antineoplastic agents belonging to the taxoid family. 3. Prior anticancer therapy within 21 days prior to the first day of study treatment. 4. Participation in another experimental drug study within 30 days prior to the first day of study treatment. 5.If bilirubin > ULN, or if SGOT and/or SGPT > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN. 6. If neutrophil counts are < 1500 cells/mm3 7.Any other condition that, in the investigators judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Parameters: Cmax, AUC0-t, AUC0-∞Timepoint: NA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Parameters: Tmax, λz, t½, AUC_%Extrap, CL and VzTimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Praveen Shetty
Lambda therapeutic research Ltd
Outcome results
None listed