Health Condition 1: null- Female subjects 18 to 75-years of age with confirmed diagnosis of breast cancer and the performance status â?¤ 2 on the ECOG performance scale (life expectancy of at least 12-weeks) Health Condition 2: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Paclitaxel nano-dispersion: 6-cycles with gap of 3 weeks between them
Control Intervention1: Marketed Paclitaxel nano-dispersion: 1 cycle
Control Intervention2: Conventional Paclitaxel:
Sponsors
Sun Pharma Advanced Research Company Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • Histologically or cytologically confirmed diagnosis of breast cancer after failure of combination chemotherapy for metastatic disease. • Female subjects with age 18 to 75-years inclusive; • Performance status • Must have estimated life expectancy of at least 12-weeks; • Measurable or evaluable disease as per RECIST criteria; • Must have adequate organ and immune system function as indicated by the following laboratory values, obtained ANC >= 1.5 Ã? 109 /L; Hb >= 9.0 g/dL; Platelets>= 100 Ã? 109 /L; Sr Creatinine: • 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; • Prior chemotherapy containing taxanes must have been completed at least 48-weeks before enrollment in this study; • If subject has received taxanes as adjuvant therapy, she must not have relapsed with breast cancer within 48-weeks of completing adjuvant taxane therapy; • Prior hormonal therapy for breast cancer must have been completed at least 2-weeks before enrollment in this study; • Female subjects with childbearing potential must have negative serum pregnancy test within last 7-days of study enrollment. Women of reproductive potential must use an effective contraceptive method while enrolled in the study; • Willing to participate and give written informed consent.
Exclusion criteria
Exclusion criteria: • 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; • Subjects with diabetes mellitus; • Pre-existing peripheral neuropathy (grade 1 or higher â?? 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 >=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 find MTD and PK data for test formulation. To compare adverse events with test formulation.Timepoint: At the end of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor response by Response Evaluation Criteria in Solid Tumors 1.0 (RECIST) criteria.Timepoint: 0.5, 1, 1.5, 2.5, 3.5, 6.5 hours | — |
Countries
India
Contacts
Public ContactDr Mudgal Kothekar MD
Sun Pharma Advanced Reserach Company Ltd.
Outcome results
None listed