Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Endoxifen: Endoxifen Enteric coated Tablets 1mg and 2 mg,
Manufactured by Intas Pharmaceuticals Ltd., India.
Control Intervention1: NIL: NIL
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient willing to give written informed consent to participate in the study before initiating any study related procedures. 2. Female more than 18 years of age on the day of signing the ICD 3. Patient with histologically or cytologically confirmed breast cancer before signing of ICD 4. Patients must have confirmation of inoperable metastatic breast cancer before signing of ICD 5. The patients should be eligible for third line therapy with resistance to Tamoxifen or Aromatase Inhibitors. 6. Pt must have negative serum pregnancy test at screening (need not to be performed for postmenopausal women).
Exclusion criteria
Exclusion criteria: 1.Patient with known history of drug addiction within last 1 year. 2.Patients with known CNS lesions (brain metastasis or carcinomatous meningitis). 3.Patient with history of Thromboembolism or stroke. 4.Known case of HIV infection. 5.Patient with history of ocular disturbances including corneal changes, decrement in color vision perception, retinal vein thrombosis, cataract and retinopathy. 6.Patient with history of endometrial adenocarcinoma, uterine sarcoma or known history of abnormal vaginal bleeding. 7.Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate safety, tolerability and steady state Pharmacokinetics (PK) of Endoxifen at escalating multiple-dose administered for 28 days in metastatic breast cancer patientsTimepoint: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate Pharmacodynamics (PD) of Endoxifen administered for 28 days in metastatic breast cancer patients. Assessment of PD includes improvement in serum estradiol,estrone, and estrone sulfate levels.Timepoint: 28 days | — |
Countries
India
Contacts
Public ContactRajesh CN
NIL
Outcome results
None listed