Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Paclitaxel protein-bound particles for injectable suspension, rapid suspension (albumin-bound) (SYHX2011G1) 100mg/vial: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Dosage: 260
Sponsors
Conjupro Biotherapeutics, Inc.
CBCC Global Research
Eligibility
Inclusion criteria
Inclusion criteria: Subjects will be considered eligible for the study based on the following criteria. 1. Willing and able to provide written informed consent prior to any study related activities being performed and to follow protocol requirements. 2. Female subjects aged 18 to 75 years, both inclusive, and having body mass index at least 17 kilograms per meter squared. 3. Subjects with histopathologically or cytologically confirmed breast cancer. 4. Subjects with breast cancer after failure of combination chemotherapy for metastatic disease or having relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. 5. Eastern Cooperative Oncology Group performance status of less than or equal to 2. 6. Life expectancy of at least 3 months at the time of enrolment. 7. Acceptable hematology status: a. Hemoglobin at least 9 grams per deciliter b. Absolute neutrophil count at least 1500 cells per microliter c. Platelet count at least 100000 cells per cubic millimeter 8. Acceptable liver function: a. Alanine aminotransferase less than or equal to 2.5 times the upper limit of normal. For patients with liver metastasis, less than or equal to 5 times the upper limit of normal b. Aspartate aminotransferase less than or equal to 2.5 times the upper limit of normal. For patients with liver metastasis, less than or equal to 5 times the upper limit of normal c. Bilirubin less than or equal to 1.5 times the upper limit of normal d. Alkaline phosphatase less than or equal to 2.5 times the upper limit of normal. For patients with liver metastasis, less than or equal to 5 times the upper limit of normal 9. Subjects with creatinine clearance at least 45 milliliters per minute using the Cockcroft Gault equation: For males: Creatinine clearance equals open bracket 140 minus age in years close bracket multiplied by weight in kilograms divided by open bracket 72 multiplied by serum creatinine in milligrams per deciliter close bracket For females: Creatinine clearance equals open bracket 140 minus age in years close bracket multiplied by weight in kilograms multiplied by 0.85 divided by open bracket 72 multiplied by serum creatinine in milligrams per deciliter close bracket 10. Subjects of child bearing potential with negative serum pregnancy test at screening and negative urine pregnancy test at Day 0. 11. Women of child bearing potential, defined as women physiologically capable of becoming pregnant, unless they are using an effective method of contraception during treatment with the investigational product, must practice two acceptable methods of contraception during the study and for at least 6 months after the last dose of study medication. Female subjects of non child bearing potential or who have completed menopause are not required to use an effective method of contraception during the study. Acceptable methods of contraception are: a. Hormonal method, including oral, vaginal ring, transdermal patch, implanted, or injection, started at least 7 days prior to Day 0 plus one barrier method such as cervical cap, diaphragm, contraceptive sponge, vaginal spermicide, female condom, or male condom b. Intrauterine device or intrauterine system placed 7 days prior to Day 0 c. Two barrier methods used together such as cervical cap, diaphragm, co
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study based on the following criteria: 1. Known hypersensitivity to Paclitaxel, other taxane products or the components of Paclitaxel protein-bound particles for injectable suspension (albumin-bound) or to any of the excipients. 2. In addition to cancer, have any other serious liver, kidney/genitourinary, gastrointestinal (e.g., abdominal inflammation), cardiovascular (e.g., congestive heart failure, ventricular arrhythmia, myocardial infarction, unstable angina), cerebrovascular, pulmonary (e.g., interstitial lung disease), endocrine, immune, musculoskeletal, neurological, psychiatric, skin, or blood (e.g., bleeding tendency or clotting disorders) diseases. 3. Major surgical procedure (including periodontal) within 4 weeks prior to screening or planned to undergo major surgery during the study period 4. Subjects with positive serology for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb) and Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).Note: Subjects with Hepatitis B core antibody (HBcAb) positive result, can be enrolled if a confirmatory negative test is obtained suggestive of no active infection currently. 5. Subjects with congenital long QT syndrome or demonstration of repeated prolonged QTc interval greater than 470 milliseconds in females. QTc interval to be calculated with Fridericia formula as QT divided by open bracket 60 divided by heart rate close bracket raised to the power of 0.33. 6. Subjects with Grade 2 or higher peripheral neuropathy. 7. Subjects with history of other malignancy within the last five years prior to screening. Potential patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. 8. History or presence of sepsis or pneumonitis. 9. Presence of any uncontrolled systemic disease such as cardiovascular disease, hypertension, or diabetes mellitus. 10. Subjects who have been administered any inhibitors or inducers of either CYP2C8 or CYP3A4 within 28 days prior to dosing. Acceptable drug use is stable in homeostasis, meaning the dosing regimen remains unchanged. However, the use of moderate to strong inhibitory agents or moderate to strong inducers or drugs including herbal medicines that can affect the absorption, distribution, metabolism, and excretion of the study drugs should be prohibited. 11. Subjects who have consumed more than 14 units of alcohol per week in the 3 months before screening, where 1 unit is approximately 360 milliliters for beer, or 45 milliliters for spirits, or 150 milliliters for wine, or who cannot stop drinking during the study period or who are urine positive for alcohol. 12. Subjects who are smoking more than 5 cigarettes per day within 3 months prior to screening or who cannot stop smoking during the study. 13. History of drug abuse, except regular use of pain medications due to cancer pain, or subjects with positive urine screen for drugs of abuse including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, and morphine. 14. Has not recovered to Grade 0 or Grade 1 toxicity from previous anticancer treatments or previous investigational agents. Exceptions are alopecia, where any grade is acceptable, and fatigue, where Grade 2 is acceptable, as per National Cancer Institute Common Terminology Criteria for Adverse Events Version 6.0. 15. Subjects receivin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetic consistency of SYHX2011G1 of Conjupro Biotherapeutics, Inc. with paclitaxel protein-bound particles for injectable suspension (albumin-bound) (Abraxane ) of Abraxis BioScience, LLC in breast cancer patientsTimepoint: A total of 16 blood samples will be collected in each study period. The pre-infusion blood sample (0.00) will be collected within 1 hour prior to start of infusion. After start of infusion, blood samples will be collected at 0.25 (15 min), 0.50 (30 min), 0.67 (40 min), 0.83 (50 min), 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 24.00, 48.00 and 72.00 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events & to ensure the safety & tolerability of investigational product in study patients.Timepoint: approximately 64 days | — |
Countries
India
Contacts
Public ContactDr Sandeep Singh
CBCC Global Research
Outcome results
None listed