Health Condition 1: null- locally advanced or metastatic breast cancer, locally advanced non-small cell lung cancer, hormone refractory metastatic prostate cancer, other tumor type with no standard treatment
Conditions
Interventions
Intervention1: Docetaxel injection concentrate for nano-dispersion (DICN): 1 Cycle
Control Intervention1: Polysorbate 80 based Docetaxel formulation: 1 cycle
Sponsors
Sun Pharma Advanced Research Company Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Histologically or cytologically confirmed advanced cancer potentially sensitive to single agent docetaxel; e.g. locally advanced or metastatic breast cancer, locally advanced non-small cell lung cancer, hormone refractory metastatic prostate cancer, other tumor type with no standard treatment. Age 18 to 65-years inclusive; Performance status less than or equal to 2 on the ECOG performance scale; Estimated life expectancy of at least 12-weeks; Adequate organ and immune system function as indicated by the following laboratory values, obtained less than or equal to 2 weeks prior to dosing; Any chemotherapy (except taxanes), major surgery, or irradiation must have been completed at least 4-weeks before enrollment in this study (6-weeks for Mitomycin C or nitrosurea); subjects must have recovered from all toxicities incurred as a result of previous therapy; Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s) from atleast 2 months prior to study entry and through the duration of the study; or postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); with a negative urine pregnancy test;Willing to participate and give written informed consent.
Exclusion criteria
Exclusion criteria: Hematological malignancies including leukemia, lymphoma or multiple myeloma; Uncontrolled angina, subjects with a history of myocardial infarction within 2-months of enrollment, or subjects with cardiac functional capacity Class III or IV as defined by NYHA classification; Known hypersensitivity to study drugs or its excipients or analogs; Treatment with any investigational agents within 30-days of study entry; Active and uncontrolled infection; Psychiatric disorders or alcohol/chemical abuse that would interfere with consent or follow-up; Presence of clinically apparent CNS metastases or carcinomatous meningitis; Pre-existing peripheral neuropathy (grade 1 or higher ? as per CTCAE); Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study; HIV positive or who have an AIDS-related illness; Prior radiation therapy to less than or equal to 25% of the bone marrow (e.g. whole pelvic radiation is allowed). Subjects must have recovered from the acute side effects of radiotherapy; Prior bone marrow/stem cell transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine MTD and PK profile of DICNTimepoint: End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate safety of DICN as per CTCAE.Timepoint: During course of study | — |
Countries
India
Contacts
Public ContactDr Mudgal Kothekar MD
Sun Pharma Advanced Research Company Limited
Outcome results
None listed