Health Condition 1: null- Breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.
Conditions
Interventions
Intervention1: Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial: Cipla Ltd.,India. Patients will receive 260mg/m2 dose of the study drug on the first day of the
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Female patients, 18 to 65 years of age (both inclusive) at the time of screening and capable of giving written informed consent prior to receiving any study medication. 2.Has histological or cytological confirmed metastatic breast cancer after failure of combination chemotherapy for metastatic disease or has had a relapse within 6 months of adjuvant chemotherapy (Prior therapy should have included an anthracycline unless clinically contraindicated). 3.Patients with life expectancy of at least 3 months as per the investigators opinion. 4.ECOG performance status of less than or equal to 2. 5.Acceptable hemopoeitic, renal and liver function. Bone marrow function ANC more than or equal to 1500/mm3, Platelet count more than or equal to 100,000/mm3 Hemoglobin more than or equal to 9.0 g/dl Renal function Serum Creatinine less than 1.5 times ULN Hepatic function AST and ALT less than or equal to 2.5 times ULN Alkaline phosphatase less than 2 times ULN Bilirubin less than or equal to 1.5 times ULN 6.All other clinical laboratory values deemed as not clinically significant by the principal investigator/sub-investigator. 7.Availability for the entire study duration and willingness to comply/adhere to the protocol requirements. 8.Women of childbearing potential must have a negative serum pregnancy test, must be using an adequate method of contraception and must be willing to avoid getting pregnant during the study. Female patients must fulfill at least one of the following: •Be surgically sterile for a minimum of 6 months; •Post-menopausal for a minimum of 1 year; •Agree to avoid pregnancy and use medically acceptable method of contraception from at least 30 days prior and until 30 days after the study has ended (last study procedure). •Medically acceptable methods of contraception include non-hormonal intrauterine device or double barrier method (condom with foam or vaginal spermicidal suppository, diaphragm with spermicide). Complete abstinence alone can be used as a method of contraception.
Exclusion criteria
Exclusion criteria: 1.History of allergy or hypersensitivity reactions to a paclitaxel or the components of paclitaxel protein-bound particles for injectable suspension (albumin-bound) or any related compound at any dose. 2.Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal (e.g., intra-abdominal inflammation), cardiovascular (e.g., congestive heart failure, ventricular arrhythmia, myocardial infarction, unstable angina pectoris), cerebrovascular, pulmonary (e.g., interstitial lung disease), endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological (e.g., bleeding diathesis or coagulopathy) disease or condition other than cancer unless determined as not clinically significant by the investigator. 3.History of any other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer. 4.Sensory peripheral neuropathy of > Grade 2 at baseline. 5.Presence of any significant physical or organ abnormality or active opportunistic infection (i.e. mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis jiroveci) as determined by the Investigator. 6.Patients not completely recovered from any toxicities from previous chemo-, hormone-, immuno-, or radiotherapies less than or equal to Grade 1. 7.A positive HIV, Hepatitis B surface antigen, Hepatitis C, drugs of abuse or breath alcohol test. 8.Difficulty in fasting or consuming standard meals. 9.Patients who are: •pregnant •breast feeding •of childbearing potential without a negative pregnancy test at baseline •had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery 10.Known history or presence of: •Alcohol abuse or dependence within one year prior to first drug administration; •Drug abuse or dependence; •Severe allergic reactions (e.g. anaphylactic reactions, angioedema) 11.History of difficulty with donating blood or difficulty in accessibility of veins. 12.Any clinically significant abnormal findings in 12 lead ECG, 2D ECHO, X-ray findings, as judged by investigator. 13.Patient is taking inhibitor, or inducer of CYP2C8 or CYP3A4 enzymes and in whom these drugs are unable to be restricted for the entire study period. 14.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. 15.Participation in any clinical study, chemotherapy and/ or radiotherapy within the past 30 days of first IP administration or has less than 5 washout periods from previous therapy. 16.Patients who have not recovered from the side effects of previous therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare and evaluate the single dose bioavailability of paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial of test and reference product.Timepoint: Pre-dose sample (within 5 mins prior to dosing), post-dose blood samples - after start of intravenous infusion, will be collected at 0.083 (5 min), 0.167 (10 min), 0.333 (20 min), 0.417 (25 min), 0.50 (30 min), 0.580 (35 min), 0.750 (45 min), 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events and to ensure the safety of patients.Timepoint: NA | — |
Countries
India
Contacts
Public ContactMonica Razdan
Cipla Ltd.
Outcome results
None listed