Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: NDLS_Intas: Dose: 60, 75 and 100 mg/m2, Mode of Administration: IV, Duration of treatment and frequency:6 cycles (21 days per cycle)
Control Intervention1: Not Applicable: Not Applicabl
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.The patient willing to give written signed and dated informed consent to participate in the study. 2.Female >=18 years and 3.Patient must have histopathologically /cytologically confirmed breast cancer. 4.Patient must have locally advanced or metastatic breast cancer after failure of chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated 5.Have at least one measurable lesion as per the RECIST criteria (version 1.1). 6.Eastern Cooperative Oncology Group (ECOG) performance status 7.Left Ventricular Ejection fraction (LVEF) >= 50% as per Echocardiography (ECHO). 8.Patient must have recovered from any toxic effects of previous chemotherapy or radiotherapy as judged by the Investigator. 9.Previous chemotherapy/radiotherapy should be completed 4 weeks prior to start of IMP administration. 10.Patients with life expectancy of at least 6 months. 11. Serum pregnancy test at screening and urine pregnancy test on Day 1(before randomization) must be negative. 12.Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to Study drug administration] for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. (It is investigatorâ??s responsibility to ensure that above points regarding an effective method of avoiding pregnancy are discussed with patient in detail and patient agreed for this and it is documented in source document. The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol). 13.Patient with adequate bone marrow, renal and hepatic function.
Exclusion criteria
Exclusion criteria: 1.Patient who has a history of hypersensitivity reactions to docetaxel or any other component of formulation or to any drugs formulated with polysorbate 80. 2.Patients with HER2+ status 3.Patient who is already exposed to docetaxel injection. 4.Any of the following cardiac conditions: a.Unstable angina b.Myocardial infarction within the past 6 months c.Severe uncontrolled ventricular arrhythmias d.Clinically significant pericardial disease e.Electrocardiographic evidence of acute ischemia f.Patient with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) except in whom the disease has been stable for the past six months g.History of cardiac disease that met the NYHA Classification class 2 or greater. 5.Uncontrolled diabetes or infection. 6.Known history of drug addiction within last 1 year. 7.Patients with known CNS lesions (brain metastasis or carcinomatous meningitis). 8.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. 9.Pre-existing motor or sensory neurotoxicity of a severity >= grade 2 as defined by NCI CTCAE 4.03 criteria. 10.Known case of HIV infection. 11.Any other condition that, in the investigatorâ??s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study. 12.Patients who are unwilling or unable to follow protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ To compare safety, pharmacokinetics (PK) of NDLS at three dose levels in locally advanced or metastatic breast cancer patients.Timepoint: 6 cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ To compare the BOR (CR or PR) to evaluate the efficacy of NDLSTimepoint: 6 cycles;â?¢ To evaluate the exploratory exposure-response relationship for NDLS in patients for efficacy and toxicity in locally advanced or metastatic breast cancerTimepoint: 6 cycles | — |
Countries
India
Contacts
Public ContactDr Ankit Ranpura
Lambda Therapeutic Research Ltd
Outcome results
None listed