Health Condition 1: C801- Malignant (primary) neoplasm, unspecified
Conditions
Interventions
Intervention1: Cabazitaxel Lipid Suspension for injection 50 mg/vial: Dose-15,20 and 25 mg/m2,Frequency-Single dose,Mode of Administration-IV,Duration of treatment-1 cycle
Control Intervention1: JEVTA
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient and /or LAR or impartial witness able to give written informed consent for participation in the trial. 2. Male or female patients with age >= 18 years at the screening visit. 3. Patients with histopathologically/cytologically confirmed following primary advanced solid tumors: Breast cancer, Head and neck, Lung, Melanoma, gastric, colon or Prostate for which Cabazitaxel monotherapy is a viable treatment option. 4. Patients with advanced solid malignancies refractory to conventional treatment. 5. Patient with an ECOG performance status of 0-2. 6. Patient must have an adequate bone marrow, renal and hepatic function 7. Patient should be able to comply with study procedures in the opinion of the investigator. 8. Life expectancy should be >2 months
Exclusion criteria
Exclusion criteria: 1. Known hyper sensitivity to Cabazitaxel or any of its excipients or related group of drugs. 2. Intolerance to any antineoplastic agents belonging to the taxane family. 3. If the patient had undergone prior surgery, radiation, chemotherapy, or other anticancer therapy within 4 weeks (28 days) prior to dosing in the study 4. Patients with known human immunodeficiency virus (HIV) infection. 5. A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies. 6. Use of any recreational drugs or history of drug addiction. 7. 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. 8. Any other condition or abnormal baseline findings that, in the investigatorâ??s judgement, 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 |
|---|---|
| â?¢ To evaluate the pharmacokinetic profile of escalating dose of the sponsorâ??s test formulation (Cabazitaxel Lipid Suspension for injection) relative to that of reference formulationTimepoint: 0.5, 1, 2, 4, 24 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ To monitor the safety and tolerability of the patients exposed to the Investigational Medicinal Product.Timepoint: At the end of study | — |
Countries
India
Contacts
Public ContactDevang Chauhan
Lambda Therapeutic Research Ltd
Outcome results
None listed