Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin bound)of Amneal EU Limited Ireland: Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) 10
Sponsors
Amneal EU Limited
AXIS Clinicals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient with confirmed diagnosis of metastatic breast cancer or breast cancer. 2. Female patient,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 should meet one of the following criteria. a. Has histological or cytological confirmed metastatic breast cancer after failure of combination chemotherapy for metastatic disease. b. Has had a relapse within 6 months of adjuvant chemotherapy. c. Has histological or cytological confirmed breast cancer who is a candidate for albumin bound paclitaxel therapy in accordance with the standard of care (NCCN guidelines- Breast Cancer) as per the judgement of the PI. Note: In case of points a and b, patient should have received prior therapy of an anthracycline unless clinically contraindicated 3. Patient having clinically non-significant ECG and chest X-ray (PA view) as per PI discretion. 4. Patient with ECOG status of 0 to 2 (both inclusive). 5. Patient has adequate hematological, renal, and hepatic function as defined by the following: a. Absolute neutrophil count (ANC) greater or equal to 1500 cells per mm3 (1.5x10 raised to the power of 9 per L) b. Platelet count greater or equal to 100000 cells per mm3 (100x10 raised to the power of 9 per L) c. Hemoglobin greater or equal to 9 g per dL d. Serum creatinine smaller or equal to 1.95 mg per dL e. Creatinine clearance greater or equal to 60 mL per minute f. Total bilirubin smaller or equal to 1.8 mg per dL if patient had liver per bone metastasis, total bilirubin smaller or equal to 3.6 mg per dL will be considered. g. AST (SGOT) smaller or equal to 105 U per L if patient had liver or bone metastasis, AST smaller or equal to 210 U per L will be considered. h. ALT (SGPT) smaller or equal to 137.5 U per L if patient had liver per bone metastasis, ALT smaller or equal to 275 U per L will be considered. i. ALP (Alkaline phosphatase) smaller or equal to 375 U per L if patient had liver or bone metastasis, ALP smaller or equal to 750 U per L will be considered. 6. Patient has expected survival of more than 3 months. 7. Patient with body surface area within 1.2 to 2.2 m2, calculated using the Mosteller Formula 8. Nonpregnant and nonlactating Female Patient 9. Patient with negative serum pregnancy test at screening and negative urine pregnancy test at Day -1. 10. No history of addiction to any recreational drug or drug dependence or alcohol addiction. 11. Female patient of childbearing potential should be willing to use a reliable method of birth control during course of the study and at least 6 months following last dose of IP. Acceptable form of birth control include Tubal sterilization (tubal ligation performed more than one month before Study Day 1, transcervical tubal occlusion procedure performed more than six months before Study Day 1) Intrauterine Device (IUD) Two barrier methods used together (cervical cap, diaphragm contraceptive sponge, or vaginal spermicide plus a male or female condom)
Exclusion criteria
Exclusion criteria: 1. Patient with a history of other malignancies, except for adequately treated nonmelanoma skin cancer, curatively treated in-situ carcinoma of the cervix, in-situ carcinoma of the breast or other solid tumors with no evidence of recurrence for greater or equal to 5 years. 2. Patient who experiences a severe hypersensitivity reaction to Paclitaxel other taxane product or the components of Paclitaxel protein-bound particles for injectable suspension (albumin-bound) or to any of the excipients. 3. Patient who has previously received a taxane within the 30 days prior to randomization. 4. Patient who is using gemcitabine. 5. Patient who has not completely recovered from any toxicities from previous chemotherapy, hormone therapy, immunotherapy, or radiotherapies Grade 2 or higher by CTCAE, with the exception of alopecia. 6. Patient with Sensory or Peripheral neuropathy of Grade 2 or higher by CTCAE. 7. Patient with known brain metastases 8. Patient with severe myelosuppression. 9. Patient with history or presence of sepsis or pneumonitis. 10. Patient with history of difficulty with vascular access. 11. Patient with positive test for alcohol breath test and or or urine drugs of abuse (except for morphine and or or benzodiazepines which are permissible when supported by a prescription). 12. Patient with positive test for HIV 1 & 2 or HBsAg or HCV at screening. 13. Patient with history of difficulty with donating blood or patient donated blood or participated in any clinical study with loss of greater or equal to 350 mL (1 unit) of blood prior to 3 months of screening or difficulty in accessibility of veins. 14. Patient had major surgery within 30 days prior to randomization, or patient has not recovered from prior major surgery. 15. Patient with known history or presence of any clinically significant disease or condition other than cancer unless determined as not clinically significant by the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish bioequivalence between the Test and the Reference product based on ln-transformed pharmacokinetic parameters Cmax, AUC0-t, and AUC0-infinity for unbound and total paclitaxel.Timepoint: Day 35 | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, Kel, T half, and AUC percent extrapolation will be reported for unbound and total paclitaxel.Timepoint: Day 35;To assess safety and tolerability by considering reported adverse events, laboratory and clinical investigations, and vital signsTimepoint: Every Visit | — |
Countries
India
Contacts
Public ContactDr Subhra Lahiri
AXIS Clinicals Ltd
Outcome results
None listed